Impact of BPC-157 on Recovery Following Rotator Cuff Repair Surgery
NCT07803250 · PHASE1 · NOT_YET_RECRUITING · Rotator Cuff Tear · 18 Years
Registered intervention descriptionBPC-157: BPC-157 is a synthetic pentadecapeptide derived from human gastric juice. It has demonstrated pro-angiogenic, cytoprotective, and tissue-regenerative effects in multiple preclinical models of musculoskeletal injury, including tendon and ligament healing. Although widely discussed in experimental and anecdotal contexts, BPC-157 has not undergone formal human clinical trials and remains an investigational compound not approved by the FDA. This study is designed to explore its potential role in promoting tendon regeneration and functional recovery in a postoperative orthopaedic setting. Sham (No Treatment): Participants in this group will not receive any active treatment or placebo injections. This sham group serves as a no-treatment control to evaluate the natural course of postoperative recovery following arthroscopic rotator cuff repair without investigational intervention. Participants will continue to receive standard postoperative...
Registered arm groupsBPC-157 Group, Sham
BPC 157 for Acute Hamstring Muscle Strain Repair
NCT07437547 · PHASE2 · RECRUITING · Hamstring Muscle Strain, Skeletal Muscle Injury · 18 Years · 45 Years
Registered intervention descriptionPentadecapeptide BPC 157: subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.
Placebo: subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.
Registered arm groupsArm 1: Experimental - BPC 157, Arm 2: Placebo Comparator - Placebo
PCO-02 - Safety and Pharmacokinetics Trial
NCT02637284 · PHASE1 · UNKNOWN · Healthy Volunteers · 18 Years · 35 Years
Registered intervention descriptionBepecin: Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.
Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics.
Placebo: Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.
Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group.
Registered arm groupsIntervention 1a (cohort 1), Intervention 1a (cohort 2), Intervention 1a (cohort 3), Intervention 1b, Control group 1 a (cohort 3), Control group 1a (cohort 1), Control group 1a (cohort 2), Control group 1b
A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight
NCT07745504 · PHASE3 · RECRUITING · Overweight, Obesity · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously.
Placebo cagrilintide: Placebo matched to cagrilintide will be administered subcutaneously.
Registered arm groupsCagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2, Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1, Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
NCT07607587 · PHASE1 · RECRUITING · Obesity, Overweight · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously.
Placebo (matched to Cagrilintide): Placebo matched to Cagrilintide will be administered subcutaneously.
Registered arm groupsCagrilintide, Placebo
A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight
NCT07605052 · PHASE1 · COMPLETED · Overweight, Obesity · 18 Years · 64 Years
Registered intervention descriptionCagrilintide B: Cagrilintide B will be administered subcutaneously.
Cagrilintide D: Cagrilintide D will be administered subcutaneously.
Registered arm groupsCagrilintide B, Cagrilintide D
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
NCT07564414 · PHASE3 · RECRUITING · Obesity, Type 2 Diabetes · 18 Years
Registered intervention descriptionCagrisema: Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Registered arm groupsCagrisema - dose level 1, Cagrisema - dose level 2
A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
NCT07557953 · PHASE1 · RECRUITING · Overweight, Obesity · 18 Years · 64 Years
Registered intervention descriptionCagrilintide: Cagrilintide is administered subcutaneously .
Placebo Cagrilintide: Placebo Cagrilintide is administered subcutaneously.
Registered arm groupsCagrilintide, Placebo Cagrilintide
A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity
NCT07597018 · PHASE1 · RECRUITING · Obesity, Overweight · 18 Years · 64 Years
Registered intervention descriptionCagrilintide D: Cagrilintide D will be administered subcutaneously.
Cagrilintide B and placebo semaglutide I: Cagrilintide B and placebo semaglutide I will be administered subcutaneously
Registered arm groupsCagrilintide D-Injection site 1, Cagrilintide D-Injection site 2, Cagrilintide D-Injection site 3, Cagrilintide B and Placebo Semaglutide I
Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health)
NCT07527195 · PHASE1 · RECRUITING · Obesity · 50 Years · 70 Years
Registered intervention descriptionCagrilintide: Participants will receive cagrilintide subcutaneously.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema, Cagrilintide, Placebo
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese
NCT07411560 · PHASE1 · RECRUITING · Overweight, Obese · 18 Years · 64 Years
Registered intervention descriptionCagrilintide: Participants will receive Cagrilintide subcutaneously.
Registered arm groupsArm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide, Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide, Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide, Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
NCT07357766 · PHASE3 · WITHDRAWN · Overweight, Obesity · 18 Years
Registered intervention descriptionCagrisema: Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
Placebo CagriSema: Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Registered arm groupsCagriSema B in device 2 + Placebo in device 1, CagriSema in device 1 + Placebo in device 2, Placebo in device 1 + Placebo in device 2
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
NCT07357740 · PHASE2 · WITHDRAWN · Diabetes Mellitus, Type 2 · 18 Years · 64 Years
Registered intervention descriptionCagriSema: Cagrilintide and Semaglutide will be administered subcutaneously using device 1 or device 2.
Placebo CagriSema: Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Registered arm groupsCagriSema B in device 2 + Placebo CagriSema in device 1, CagriSema in device 1 + Placebo CagriSema B in device 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
NCT07282613 · PHASE3 · RECRUITING · Diabetes Mellitus, Type 2 · 10 Years · 18 Years
Registered intervention descriptionCagriSema (Cagrilintide B and Semaglutide I): Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I): Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Registered arm groupsPart 1: CagriSema, Part 2: CagriSema, Part 1: Placebo
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
NCT07253285 · PHASE3 · RECRUITING · Overweight, Obesity · 8 Years · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive cagrilintide subcutaneously.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema, Cagrilintide, Placebo
Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
NCT07220642 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity, Overweight · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo: Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Registered arm groupsCagrilintide, Placebo
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
NCT07220759 · PHASE3 · ACTIVE_NOT_RECRUITING · Overweight, Obesity, Type 2 Diabetes · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo (matched to Cagrilintide): Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Registered arm groupsCagrilintide, Placebo
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
NCT07184086 · PHASE1 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years · 65 Years
Registered intervention descriptionCagriSema (Cagrilintide B + semaglutide I): Cagrilintide and semaglutide will be administered subcutaneously.
Registered arm groupsCagriSema (Cagrilintide + Semaglutide) / CagriSema, Low Energy Diet (LED) / CagriSema
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
NCT07011667 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years
Registered intervention descriptionCagriSema (Cagrilintide B and Semaglutide I): CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I): Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Registered arm groupsCagriSema, Placebo
The Role of the Amylin Analogue Cagrilintide in Bone Metabolism
NCT07010432 · PHASE1 · RECRUITING · Obesity · 50 Years · 70 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly cagrilintide subcutaneously.
Placebo cagrilintide: Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema, Cagrilintide, Placebo
A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
NCT06797869 · PHASE2 · COMPLETED · Diabetes Mellitus, Type 2, Diabetic Peripheral Neuropathy · 18 Years
Registered intervention descriptionCagriSema (Cagrilintide B and Semaglutide I): Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I): Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Registered arm groupsCagriSema, Placebo
A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
NCT06780449 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive cagrilintide subcutaneously.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema, Placebo
A Study on How NNC0174-1213 Works in People With Overweight or Obesity.
NCT06719011 · PHASE1 · COMPLETED · Obesity, Overweight · 18 Years · 55 Years
Registered intervention descriptionCagrilintide B: Participants will be randomized to receive Cagrilintide B administered as subcutaneous (s.c. under the skin) injection.
Single ascending dose (SAD) will be injected for Part A cohorts and multiple ascending doses (MAD) will be injected for Part B cohorts.
Registered arm groupsPart A: Cagrilintide (SDA and SDB), Part A: NNC0174-1213 (SD1-SD5), Part A: Placebo, Part B: Cagrilintide (MDA), Part B: NNC0174-1213 (MD1-MD5), Part B: Placebo
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Single Doses of Different Versions of Injectable CagriSema in Adults With Overweight or Obesity
NCT06716307 · PHASE1 · COMPLETED · Obesity · 18 Years · 64 Years
Registered intervention descriptionCagriSema (cagrilintide B and semaglutide I): Cagrilintide and semaglutide will be administered subcutaneously using DV3384 pen-injector.
CagriSema A: Cagrilintide and semaglutide will be administered subcutaneously using PDS290 pen-injector.
Registered arm groupsTreatment sequence 1, Treatment sequence 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
NCT06534411 · PHASE3 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly cagrilintide subcutaneously.
Registered arm groupsCagriSema
Effects of NNC0194-0499, Cagrilintide, and Semaglutide Alone or in Combinations on Liver Damage and Alcohol Use in People With Alcohol-related Liver Disease
NCT06409130 · PHASE2 · COMPLETED · Alcohol-related Liver Disease · 18 Years
Registered intervention descriptionCagrilintide + semaglutide: Administered subcutaneously.
Cagrilintide: Administered subcutaneously.
Cagrilintide placebo: Administered subcutaneously.
Registered arm groupsCagriSema, Cagrilintide + semaglutide placebo, Cagrilintide placebo + semaglutide placebo
Investigating How CagriSema, Semaglutide and Cagrilintide Regulate Insulin Effects in the Body of People With Type 2 Diabetes
NCT06403761 · PHASE1 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years · 75 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly cagrilintide subcutaneously.
Placebo cagrilintide: Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema, Cagrilintide, Placebo
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
NCT06388187 · PHASE3 · COMPLETED · Obesity · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly cagrilintide subcutaneously.
Placebo: Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.
Registered arm groupsCagriSema Dose 1, CagriSema Dose 2, Placebo Dose 1, Placebo Dose 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
NCT06323174 · PHASE3 · COMPLETED · Type 2 Diabetes · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly cagrilintide subcutaneously.
Placebo: Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Registered arm groupsCagriSema Dose 2, Cagrisema Dose 1, Placebo Dose 1, Placebo Dose 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
NCT06323161 · PHASE3 · COMPLETED · Type 2 Diabetes · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly cagrilintide subcutaneously.
Placebo: Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Registered arm groupsCagriSema Dose 1, CagriSema Dose 2, Placebo Dose 1, Placebo Dose 2
A Study on How CagriSema Affects Levels of Atorvastatin and Warfarin in the Blood of Participants With Excess Body Weight
NCT06289504 · PHASE1 · COMPLETED · Obesity · 18 Years · 65 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously once weekly.
Registered arm groupsCagriSema +Atorvastatin + Warfarin
A Study of How CagriSema Works on Appetite in People With Excess Body Weight
NCT06267092 · PHASE1 · COMPLETED · Overweight, Obesity · 18 Years · 65 Years
Registered intervention descriptionCagrilintide and Semaglutide: Participants will receive subcutaneous (s.c.) injections of Cagrilintide and Semaglutide.
Placebo: Participants will receive subcutaneous (s.c.) injections of placebo matched to Cagrilintide and Semaglutide.
Registered arm groupsPart B
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
NCT06221969 · PHASE3 · COMPLETED · Type 2 Diabetes · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously.
Registered arm groupsCagriSema
A Research Study to Look at How CagriSema Influences Food Intake, Appetite and Emptying of the Stomach in People With Excess Body Weight
NCT06207877 · PHASE1 · COMPLETED · Obesity · 18 Years · 65 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously.
Registered arm groupsCagriSema
A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo
NCT06131372 · PHASE2 · COMPLETED · Chronic Kidney Disease, Type 2 Diabetes, Obesity · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive Cagrilintide subcutaneously.
Placebo: Participants will receive placebo matched to cagrilintide or placebo matched to semaglutide subcutaneously.
Registered arm groupsCagriSema, Cagrilintide, Placebo, Semaglutide
A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
NCT06131437 · PHASE3 · COMPLETED · Obesity · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously.
Registered arm groupsCagriSema 2.4 mg/2.4 mg
A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
NCT06065540 · PHASE3 · COMPLETED · Type 2 Diabetes Mellitus · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema Dose 1, CagriSema Dose 2, Cagrilintide Dose 1, Placebo Dose 1, Placebo Dose 2
A Research Study to See How Well CagriSema Helps People in China With Excess Body Weight Lose Weight
NCT05996848 · PHASE3 · COMPLETED · Obesity or Overweight · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive 2.4 mg cagrilintide subcutaneously.
Placebo Cagrilintide: Participants will receive placebo matched to cagrilintide subcutaneously.
Registered arm groupsCagriSema, Placebo
A Research Study to See How Well CagriSema Helps People in East Asia With Excess Body Weight Lose Weight
NCT05813925 · PHASE3 · COMPLETED · Obesity or Overweight · 18 Years
Registered intervention descriptionCagrilintide: Participants will receive 2.4 mg cagrilintide s.c. OW after a dose escalation period of 16 weeks for 52 weeks
Registered arm groupsCagriSema 2.4 mg/2.4 mg
A Research Study Looking at How Cagrilintide Works on the Heart Rhythm in Healthy Participants
NCT05804162 · PHASE1 · COMPLETED · Obesity · 18 Years · 55 Years
Registered intervention descriptionCagrilintide: Participants will receive 0.6 mg subcutaneous injections of cagrilintide once weekly and the dose will be then escalated once in 2 weeks for 8 weeks until the target maintenance dose of 4.5 mg is reached followed by a 38-day post-treatment period.
Cagrilintide Placebo: Participants will receive cagrilintide placebo subcutaneously once weekly.
Registered arm groupsCagrilintide (Arm 1), Cagrilintide Placebo (Arm 2A), Cagrilintide Placebo (Arm 2B)
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
NCT05669755 · PHASE3 · ACTIVE_NOT_RECRUITING · Cardiovascular Disease · 55 Years
Registered intervention descriptionCagrilintide: Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Placebo: Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.
Registered arm groupsCagriSema, Placebo
A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
NCT05567796 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously.
Placebo cagrilintide: Participants will receive placebo matched to cagrilintide.
Registered arm groupsCagrilintide, Cagrisema, Placebo s.c., Semaglutide
A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body
NCT05564104 · PHASE1 · COMPLETED · Hepatic Impairment, Healthy Volunteers · 18 Years · 80 Years
Registered intervention descriptionCagrilintide: Cagrilintide will be administered subcutaneously in the abdomen in the form of a solution for injection as well as intravenously in the form of solution for injection.
Registered arm groupsPart A: Participants with mild hepatic impairment, Part A: Participants with moderate hepatic impairment, Part A: Participants with normal hepatic function, Part A: Participants with severe hepatic impairment, Part B: Sequence 1, Part B: Sequence 2
A Research Study to See How Well CagriSema Helps People With Type 2 Diabetes and Excess Body Weight Lose Weight
NCT05394519 · PHASE3 · COMPLETED · Overweight, Obesity, Type 2 Diabetes Mellitus · 18 Years
Registered intervention descriptionCagrilintide: Cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
Placebo cagrilintide: Placebo cagrilintide administered subcutaneously (s.c., under the skin) once-weekly
Registered arm groupsCagriSema, Placebo
Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes
NCT04982575 · PHASE2 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionCagrilintide 2.4 mg: Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Placebo (cagrilintide): Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly.
Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
Registered arm groupsCagrilintide 2.4 mg and placebo (semaglutide), Cagrilintide 2.4 mg and semaglutide 2.4 mg, Semaglutide 2.4 mg and Placebo (cagrilintide)
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
NCT04940078 · PHASE1 · COMPLETED · Obesity & Overweight · 18 Years · 55 Years
Registered intervention descriptionCagrilintide: Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks
Cagrilintide and semaglutide: Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe
Registered arm groupsPart A: Cagrilintide and semaglutide in separate syringes, Part A: Cagrilintide and semaglutide combined in DV3384 device, Part B: Cagrilintide and semaglutide combined in DV3384 device
Cerebrolysin in Early Stroke Rehabilitation - Tertiary Study
NCT07043686 · NA · RECRUITING · Ischemic Stroke, Acute, Rehabilitation Outcome, Cerebrolysin · 18 Years
Registered intervention descriptionCerebrolysin treatment: The patients will receive Cerebrolysin treatment, 10 days consecutively, 30 ml/day, intravenous infusion diluted up to 100 ml of 0.9% saline in 15 minutes.
Registered arm groupsArm 1: Cerebrolysin Group
Safety and Feasibility of Using Cerebrolysin in the Treatment of Primary Intracerebral Hemorrhage - a Prospective Randomized Open Blinded End-point Trial
NCT06899464 · PHASE4 · NOT_YET_RECRUITING · Intracerebral Hemorrhage, Hemorrhagic Stroke, Intracerebral, Hemorrhagic Stroke · 18 Years · 80 Years
Registered intervention description14-day Cerebrolysin treatment: 14-day cerebrolysin treatment initiated within 6 hours of onset of stroke
Registered arm groupsCerebrolysin
Effects of Cerebrolysin on Language Ability in Non-fluent Aphasia Patients After Stroke: A Randomized, Placebo-controlled, Double-blinded, Single Center Study
NCT06897176 · PHASE4 · RECRUITING · Stroke · 19 Years · 90 Years
Registered intervention descriptionCerebrolyisin: This intervention uses Cerebrolysin, which is a treatment aimed at improving language abilities and providing neuroprotection for patients with non-fluent aphasia following a stroke. Cerebrolysin is administered via intravenous injection, with the goal of improving language skills and promoting brain function recovery. The treatment is evaluated based on improvements in language abilities, neurological function recovery, and safety.
Placebo: The placebo is administered alongside standard language therapy to the patients with non-fluent aphasia following a stroke. This allows for comparison with the Cerebrolysin group to assess the impact of the treatment on language abilities and neurological function recovery. The goal is to evaluate the improvements in language skills, neurological function recovery, and safety, comparing the effects between the active treatment and placebo.
Registered arm groupsExperimental Group (Cerebrolysin Treatment), Placebo Group (Placebo Treatment)
Cerebrolysin in Critically Ill Patients With Delirium
NCT06677502 · NA · ENROLLING_BY_INVITATION · Cognitive Impairment · 18 Years · 100 Years
Registered intervention descriptionCerebrolysin: Patients were randomized into two groups: CBL - patients treated with cerebrolysin at the daily dose of 50 mL, and K - control patients treated without cerebrolysin. Cerebrolysin was administrated intravenously on the day the delirium was detected and then for seven consecutive days.
Registered arm groupsCerebrolysin arm.
Cerebrolysin as an Add-On Therapy to Standard Treatment of Basilar Artery Occlusion
NCT06489925 · EARLY_PHASE1 · UNKNOWN · Basilar Artery Occlusion, Posterior Circulation Brain Infarction · 18 Years
Registered intervention descriptionCerebrolysin: The Cerebrolysin will be administered at least one hour after the standard treatment and no later than 24 hours after the stroke symptom onset.
Registered arm groupsCerebrolysin group
Cerebrolysin After Reperfusion in Extended-window EndoVascular Thrombectomy
NCT06339411 · PHASE2 · NOT_YET_RECRUITING · Acute Ischemic Stroke · 18 Years · 80 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin 30 mL diluted in 70 mL normal saline will be administered intravenously over 60 minutes once daily for 10 consecutive days. Treatment will begin after successful endovascular reperfusion and randomization and within 36 hours of stroke onset.
Normal saline placebo: Normal saline 100 mL will be administered intravenously over 60 minutes once daily for 10 consecutive days according to the same schedule as Cerebrolysin. Infusion bags, drip chambers, and visible tubing will be covered to maintain masking.
Registered arm groupsCerebrolysin After Successful Extended-Window Thrombectomy, Matched Placebo After Successful Extended-Window Thrombectomy
Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke
NCT06273020 · PHASE4 · UNKNOWN · Ischemic Stroke, Acute, Diabetes Mellitus, Type 2, Blood Brain Barrier · 18 Years · 80 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days Brain-MRI with contrast after 10-14 days of cerebrolysin: Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which...
Registered arm groupsIntravenous thrombolysis and cerebrolysin, Patients with cerebrolysin without IVT, Intravenous thrombolysis without cerebrolysin
Clinical Characteristics and Treatment of Anosmia and Ageusia Due to SARS-CoV2 Variants
NCT06208540 · PHASE4 · COMPLETED · Post-covid-19 Persistent Smell and Taste Disorders · 10 Years · 70 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin Dose:5 ml ampoule (1ml contains 215.2 mg cerebrolysin) once daily through intramuscular injection five times per week, for a total of 20 treatments (for 4 weeks), after which the cycle was repeated again for at least 6 weeks till a maximum of 24 weeks.
Registered arm groupsPatients group (with interventional treatment)
CERebrolysine Effect on Blood-brain Barrier in acUte Ischemic Stroke
NCT06078215 · PHASE4 · UNKNOWN · Acute Ischemic Stroke · 18 Years
Registered intervention descriptionCerebrolysin: Intravenous infusion of 30 ml Cerebrolysine in 500 ml of buffered crystalloid solution intravenously initiated within 12 hours from symptoms onset
Registered arm groupsCerebrolysin
Combined Cerebrolysin and Amantadine Sulfate Administration for Patients With Traumatic Brain Injury in the ICU
NCT06052787 · PHASE3 · COMPLETED · Traumatic Brain Injury · 18 Years · 70 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin, a mixture of free amino acids and low molecular weight peptides, has a neurotrophic factor-like activity with immediate pleiotropic neuroprotective activity and long-term multimodal effects on endogenous post-lesional regulation. Cerebrolysin has been suggested to exert beneficial effects on neurobehavioural functions, cognitive performance , and neuro-motor recovery , as part of initial therapy in severe and moderate acute TBI.
Registered arm groupsstandard of care + Cerebrolysin, standard of care + Cerebrolysin + Amantadine sulfate
A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)
NCT06070753 · NA · UNKNOWN · Acute Ischemic Stroke · 18 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of EVT. Daily infusion for 10 consecutive days.
Registered arm groupsParticipants undergo EVT plus Cerebrolysin
Efficacy of Prednisolone Versus Cerebrolysin in the Treatment of Bell's Palsy
NCT05821075 · PHASE1, PHASE2 · RECRUITING · Bell Palsy · 18 Years · 60 Years
Registered intervention descriptionCerebrolysin: intramuscular Cerebrolysin 10 mg daily for 3 weeks
Registered arm groupsCerebrolysin, Prednisolone and Cerebrolysin
Evaluation of the Effect of Neuroprotective Drug on Treatment Result in Patients After Traumatic Brain Injury
NCT05807503 · COMPLETED · TBI (Traumatic Brain Injury) · 18 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin administration in short period of time after TBI
Registered arm groupsA with Cerebrolysin administration
CERebrolysin In CADASIL
NCT05755997 · PHASE2 · ACTIVE_NOT_RECRUITING · Cadasil · 18 Years
Registered intervention descriptionCerebrolysin: 40 ml Cerebrolysin and 60 ml 0.9% NaCl per day for 4 days every month for 1 year
Registered arm groupsStudy group 1, Study group 2
Cerebrolysin in Prevention of Postoperative Delirium in Cardiac Surgery
NCT05864677 · NA · UNKNOWN · Neurocognitive Disorders, Surgery-Complications, Critical Illness · 18 Years · 90 Years
Registered intervention descriptionCerebrolysin: Patients, who will be randomized to group CER, will receive Cerebrolysin at the dose of 50 mL before surgery, followed by 50 mL on the morning of days 1,2,3, and 4.
Registered arm groupsGroup CER - treatment with Cerebrolysin
Hair Repigmentation During Cerebrolysin Therapy
NCT05288465 · NA · COMPLETED · Hair Problems · 40 Years
Registered intervention descriptionCerebrolysin: Patients prescribed for Cerebrolysin treatment due neurological disease are invited to donate a scalp punch biopsy prior to and after completing the prescribed treatment.
Registered arm groupsHair repigmentation during Cerebrolysin treatment for neurological diseases
Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT
NCT05124353 · PHASE2, PHASE3 · UNKNOWN · Stroke, Acute, Ischemic · 18 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin 30ml i.v., administrated in first 6 hours after stroke onset and fo 10 day afterwards in Neurology Department or ICU conditions.
Registered arm groupsG1 : Treatment Group (TG)r
Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
NCT04913831 · PHASE4 · UNKNOWN · Stroke · 19 Years · 90 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
Registered arm groupsCerebrolysin
Efficacy of Cerebrolysin Treatment as an add-on Therapy to Mechanical Thrombectomy in Acute Ischemic Stroke.
NCT04904341 · PHASE3 · UNKNOWN · Stroke, Ischemic, Stroke, Acute, Stroke Sequelae · 18 Years · 80 Years
Registered intervention descriptionCerebrolysin: neuroprotection treatment
Registered arm groupsactive
the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome
NCT04751136 · PHASE2 · COMPLETED · Down Syndrome · 6 Months · 7 Months
Registered intervention descriptioncerebrolysin: Infants of the treatment group were given Cerebrolysin in a dose of 0.1 ml / kg body weight once weekly intramuscular injection for 12 month (total of 48 injections).Each selected infant, in both treatment and control group, was assessed as regard: Socioeconomic status, Nutritional status and feeding practice, assessed for neurocognitive development
Registered arm groupsIntervention Arm
Cerebrolycin for Treatment of Covid-related Anosmia and Ageusia
NCT04830943 · PHASE3 · COMPLETED · Covid19 Related Anosmia and Aguesia · 20 Years · 50 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin will be prescribed in a dose of 5 ml ampoule once daily through intramuscular injection (1ml contains 215.2 mg cerebrolysin) for five times per week, for a total of 40 treatments (for 8 weeks), after which the cycle was individually repeated according to the response of the patient to therapy for a maximum of 24 weeks
Registered arm groupsOlfactory and gustatory disorders after covid 19 infection (n = 150)
Efficacy and Safety of Cerebrolysin on Prolonged Disorders of Consciousness
NCT04427241 · PHASE4 · RECRUITING · Disorder of Consciousness, Hemorrhagic Stroke · 19 Years · 120 Years
Registered intervention descriptionCerebrolysin: 30 ml cerebrolysin + 70 ml normal saline, days 4-17, once/day, intravenously
Registered arm groupsCerebrolysin
IMPULSE - StIMulation of Brain Plasticity to Improve Upper Limb Recovery After StrokE
NCT04124367 · PHASE2 · TERMINATED · Chronic Stroke, Subacute Stroke · 18 Years · 80 Years
Registered intervention descriptionCerebrolysin: 30 ml once daily (+70 ml 0.9% saline)
Registered arm groupsVerum
Cerebrolysin and Neurodevelopment in Preterm Infants
NCT03506841 · PHASE1 · COMPLETED · Infant Development, Cerebral Palsy, Preterm Infant · 5 Months · 1 Year
Registered intervention descriptionCerebrolysin: Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).
Registered arm groupsCerbrolysin
Cerebrolysin REGistry Study in Stroke - a High-quality Observational Study of Comparative Effectiveness
NCT03480698 · COMPLETED · Acute Ischemic Stroke · 18 Years
Registered intervention descriptionCerebrolysin: Dosage, frequency, duration and mode of administration of Cerebrolysin follow the local hospital practice in accordance with the terms of the local marketing authorization and is not amended or influenced by the study. Prescribed Cerebrolysin will be used as solution for injection/concentrate for solution for infusion.
Registered arm groupsCerebrolysin and standard stroke care
Effects of Cerebrolysin Combined With Rehabilitation on Motor Recovery in Stroke
NCT02768571 · PHASE4 · COMPLETED · Stroke · 19 Years · 80 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day \* 21 days with rehabilitation
Registered arm groupsCerebrolysin
Comprehensive Reparative Therapy in Ischemic Stroke COMplex Repair in Ischemic Stroke-Arm
NCT02581371 · PHASE4 · UNKNOWN · Ischemic Stroke · 45 Years · 75 Years
Registered intervention descriptionCerebrolysin infusion: Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
Registered arm groupsCerebrolysin infusion
Cerebrolysin REGistry Study in Stroke
NCT02541227 · TERMINATED · Ischemic Stroke
Registered intervention descriptionCerebrolysin: Cerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization
Registered arm groupsCerebrolysin group
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
NCT02149875 · PHASE1, PHASE2 · COMPLETED · Acute Cerebral Stroke Within 12 Hours for the First Time · 30 Years · 90 Years
Registered intervention descriptionCerebrolysin: Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
Registered arm groupsCerebrolysin
Cerebrolysin Neural Repair Therapy in Children With Traumatic Brain Injury and Cerebral Palsy
NCT02116348 · PHASE2 · UNKNOWN · Cerebral Palsy Children, Children With Traumatic Brain Injury, Mental Handicap · 3 Months · 18 Years
Registered intervention descriptionCerebrolysin (Nerve growth factor): Cerebrolysin will be given to the intervention group
Registered arm groupsCerebrolysin
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
NCT01996761 · PHASE4 · COMPLETED · Cerebrolysin · 18 Years · 80 Years
Registered intervention descriptionporcine brain peptide (Cerebrolysin)
Registered arm groupsStudy Group 1
Cerebrolysin Compared to Donepezil in Patients With Mild to Moderate Dementia of Alzheimer's Type (DAT)
NCT01822951 · PHASE4 · WITHDRAWN · Alzheimer Disease · 50 Years
Registered intervention descriptionCerebrolysin: Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20.
Placebo for donepezil:1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o.
Registered arm groupsCerebrolysin Verum
Randomized, Double-blind, Placebo-controlled Trial to Investigate Safety and Efficacy of Cerebrolysin™ in Patients With Aneurysmal Subarachnoid Hemorrhage
NCT01787123 · PHASE2, PHASE3 · COMPLETED · Subarachnoid Hemorrhage, Intracranial Aneurysm, Delayed Cerebral Ischemia · 18 Years · 70 Years
Registered intervention descriptionIntravenous Cerebrolysin: 14-day course of intravenous Cerebrolysin started within 4 days of ictus
Registered arm groupsIntervention: standard management AND Cerebrolysin
The CAPTAIN Trial: Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery
NCT01606111 · PHASE4 · TERMINATED · Traumatic Brain Injury · 18 Years · 60 Years
Registered intervention descriptionCerebrolysin: IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30)
Registered arm groupsCerebrolysin
Navigation Brain Stimulation for Evaluation of the Neuroprotective Drug Efficiency in Patients After Ischemic Stroke.
NCT01388738 · PHASE3 · COMPLETED · Stroke · 18 Years · 70 Years
Registered intervention descriptioncerebrolysin: Cerebrolysin IV 10 ml daily 10 days
Registered arm groupscerebrolysin
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy
NCT01059461 · PHASE2 · COMPLETED · Hypoxic-Ischemic Encephalopathy · 3 Months · 6 Months
Registered intervention descriptionCerebrolysin®: injection of cerebrolysin® 0.1ml/kg IM twice weekly for 10 injections after discharge from NICU (postneonatal)
Registered arm groupsCerebrolysin®, neuroregeneration
A Clinical Trial to Evaluate the Safety and Efficacy of 20 ml Cerebrolysin in Patients With Vascular Dementia
NCT00947531 · PHASE4 · COMPLETED · Vascular Dementia · 50 Years · 85 Years
Registered intervention descriptionCerebrolysin
Registered arm groupsCerebrolysin
Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease
NCT00911807 · PHASE2 · COMPLETED · Alzheimer Disease · 51 Years
Registered intervention descriptionCerebrolysin + donepezil: Cerebrolysin (10 ml) was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions. Donepezil was given PO once daily during the whole study duration (28 weeks). After four weeks the daily dosage was increased from 5 mg to 10 mg. Cerebrolysin + placebo: Cerebrolysin (10 ml) was given as IV infusion on five days per week for four consecutive weeks (week 1-4) with repetition of this treatment course (week 13-16) after a two-months treatment free interval, accounting for a total of 40 infusions. Placebo for donepezil was given PO once daily during the whole study...
Registered arm groupsCerebrolysin + donepezil, Cerebrolysin + placebo, Donepezil + placebo
The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
NCT00868283 · PHASE4 · COMPLETED · Ischemic Stroke · 18 Years · 85 Years
Registered intervention descriptionCerebrolysin: 30 ml study drug will be given once daily by intravenous infusion for 10 consecutive days.
Registered arm groupsCerebrolysin
Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke
NCT00840671 · PHASE3 · COMPLETED · Stroke · 18 Years · 80 Years
Registered intervention descriptionCerebrolysin: Cerebrolysin, 30 ml/day as intravenous infusion, first infusion after completion of thrombolytic therapy. Daily infusion for 10 consecutive days.
Registered arm groupsCerebrolysin
Phase I: Safety and Efficacy of an Injectable Follistatin Plasmid Gene Therapy in Humans
NCT06411366 · PHASE1 · COMPLETED · Frailty, Aging · 22 Years
Registered intervention descriptionFollistatin plasmid: Follistatin-344 plasmid
Registered arm groupsExperimental
Topical GHK-Cu Gel for Acute Skin Wound Healing
NCT07437586 · PHASE2 · RECRUITING · Acute Standardized Cutaneous Wounds (Punch-biopsy Wounds) · 18 Years · 55 Years
Registered intervention descriptionGHK-Cu Gel (Copper(II)-peptide complex): topical gel, 0.1% w/w; apply a thin film (approx. 0.5 g) once daily for 14 days.
Registered arm groupsArm A: GHK-Cu Gel (0.1% w/w) applied once daily to the assigned wound for 14 days + standard non-adh, Arm B: Vehicle Gel applied once daily to the assigned wound for 14 days + standard non-adherent dres
Nephroplex — Dosage and Administration
BioActive Nutritional, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS • 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a physician for use in children under 12 years of age.
Glutathione — Dosage and Administration
Energique, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.
Apizelen — Dosage and Administration
BioActive Nutritional, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: • 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.
Free Radical — Dosage and Administration
Deseret Biologicals, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.
Free Radical — Dosage and Administration
Deseret Biologicals, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: 1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.
Kidney Tonic II — Dosage and Administration
BioActive Nutritional, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: • 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.
Hepataplex — Dosage and Administration
BioActive Nutritional, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: • 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.
Comparison Between Topical N-acetyl Cysteine (NAC) in Cold Cream Versus Cold Cream in Mild and Moderate Atopic Dermatitis: Clinical and Bacteriological Evaluation. A Randomized Control Trial.
NCT07323719 · NA · COMPLETED · Atopic Dermatitis (AD) · 2 Years · 18 Years
Registered intervention descriptionn-acetyl cyteien: n-acetyl cyteien 10% in cold cream
cold cream: cold cream is made of vaseline ,bees wax and other emollients as a placebo arm
Registered arm groupsn-acetyl cyteine arm, control arm
Effect of N-acetylcysteine as Adjunct Therapy on the Clinical Outcome of Neonatal Sepsis
NCT07380347 · PHASE3 · NOT_YET_RECRUITING · Neonatal Sepsis · 1 Day · 28 Days
Registered intervention descriptionN-Acetyl Cysteine (NAC): A group of 25 neonates will receive (12.5 mg/kg for preterm and 25 mg/kg for full-term neonates) of NAC intravenously every 12 hours for 3 days. Each dose will be infused over 60 min
Normal Saline: A group of 25 neonates as controls will receive Normal saline in the same volume of the diluted NAC.
Registered arm groupsInterventional Group, Control Group
Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia
NCT06922669 · NA · RECRUITING · Drug Induced Liver Injury · 18 Years · 80 Years
Registered intervention descriptionGlutathione: It is suitable for patients with hepatocellular or mixed DILI. A daily dose of 1.2g to 1.8g
Registered arm groupsConventional treatment, Glucocorticoids group
Expanded Access Treatment Protocol With DCA for Patients With PDCD
NCT06931262 · AVAILABLE · Pyruvate Dehydrogenase Complex Deficiency · 0 Years · 17 Years
Registered intervention descriptionDichloroacetate (DCA): Study medication DCA is an oral solution mixed with an artificial sweetener containing aspartame and strawberry extract (50mg/mL) Participants will be genotyped to determine GSTZ1 (glutathione S-transferase Zeta-1) haplotype status, which will stratify this group into 1 of 2 dose regimens: EGT carriers will receive 12 mg/kg/12hr DCA. EGT non-carriers will receive 6 mg/kg/12 hr DCA.
SPI-1005 for the Treatment of Meniere's Disease (Open Label)
NCT06859788 · PHASE3 · ACTIVE_NOT_RECRUITING · Meniere's Disease, Ménière's Disease · 18 Years · 75 Years
Registered intervention descriptionEbselen: Glutathione peroxidase mimetic
Registered arm groupsOpen Label
FEELSHION Dark Spot Remover Serum — Dosage and Administration
505G(a)(3) · Beijing JUNGE Technology Co., Ltd. · EXTRACORPOREAL
Source-supplied dosage sectionDOSAGE & ADMINISTRATION Use Morning and evening after bath.
Strength M — Dosage and Administration
BioActive Nutritional, Inc. · ORAL
Source-supplied dosage sectionDIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Identification of Serum Level of Glutathione Peroxidase 4
NCT06554392 · NOT_YET_RECRUITING · Spondyloarthropathy · 18 Years · 85 Years
Registered intervention descriptionBlood sample: Blood sample from each subject to detect Glutathione Peroxidase 4.
Registered arm groupsAnkylosing Spondylitis patients, Axial Psoriatic Arthritis Patients, healthy controls
Streptococcus Salivarius K12@Lip@GSH Alleviates Oral Mucositis in Patients Undergoing Radiotherapy
NCT06446180 · PHASE1 · COMPLETED · Oral Mucositis · 18 Years · 80 Years
Registered intervention descriptionSsK12@Lip@GSH: SsK12@Lip@GSH powder contained 1×10\^9 CFU viable cells of SsK12@Lip@GSH as the active ingredient.
Registered arm groupsExperimental group
BSS PLUS — Dosage and Administration
NDA018469 · Alcon Laboratories, Inc.
Source-supplied dosage sectionDOSAGE AND ADMINISTRATION The solution should be used according to the standard technique employed by the operating surgeon. Use an administration set with an air-inlet in the plastic spike since the bag does not contain a separate airway tube. Follow the directions for the particular administration set to be used. Insert the spike aseptically into the bag through the center target area of the rubber stopper. Allow the fluid to flow to remove air from the tubing before intraocular irrigation begins.
Clinical Analysis of Vitamin B6 in Sepsis
NCT06008223 · NA · COMPLETED · Sepsis, Vitamin B6, Kidney Injury · 18 Years · 65 Years
Registered intervention descriptionvitamin B6: The Patients in experimental group were given vitamin B6 injection 300mg/d (100mg/2ml× 3) intravenous injection.
0.9% sodium chloride solution: That in control group were injected with 0.9% sodium chloride solution 6 ml intravenously.
Registered arm groupsexperimental group (vitamin B6), control group (0.9% sodium chloride solution)
The Evaluation of Balanced Salt Solution During Cataract Surgery
NCT05853978 · PHASE4 · COMPLETED · Fuchs Dystrophy, Cataract · 22 Years
Registered intervention descriptionBSS Plus: BSS PLUS® Sterile Intraocular Irrigating Solution (balanced salt solution enriched with bicarbonate, dextrose, and glutathione)
Registered arm groupsBSS Plus
The Efficacy of Topical Serum X for Skin Brightening
NCT05693948 · NA · COMPLETED · Healthy · 18 Years · 30 Years
Registered intervention descriptionOther: Serum X: Serum X contain arbutin and glutathione
Registered arm groupsSerum X
Dates as a Functional Food for Autism
NCT04261595 · NA · COMPLETED · Autistic Spectrum Disorder · 3 Years · 12 Years
Registered intervention descriptionDates fruit as functional Food: Two groups will receive Dates; The number per group is dependant on the child age. For children aged 3-6 years; they will receive the minimum numbers of dates (3 pieces). For children aged more than 6-12 years will receive 5 pieces of Dates the choice of the minimum numbers of dates (3 pieces) in this current trial is based on a study that was done by Al Jaouni and his colleagues, 2019 which proved the effects of three pieces of Ajwa on infection, hospitalization, and survival among 26 pediatric cancer patients in a university hospital; for which their treatment outcome was improved due to their intake of this amount of Ajwa during their standard treatment nutritional Guidance: The nutritional education...
Registered arm groupsDates group 1, Dates group 2, Group 3
A Breathing-Based Meditation Intervention for Patients With Treatment Resistant Late Life Depression
NCT03368560 · PHASE1 · WITHDRAWN · Late Life Depression · 60 Years · 80 Years
Registered intervention descriptionSudarshan Kriya Yoga: Sudarshan Kriya Yoga (SKY): A 12-week training course conducted by certified instructors from the Art of Living Foundation. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario.SKY training involves attending a week-long (5 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. This will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet...
Registered arm groupsSudarshan Kriya Yoga
36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid in the Patients With Chronic Recurrent DILI
NCT03266146 · PHASE1, PHASE2 · COMPLETED · Drug-induced Liver Injury,Chronic · 18 Years · 60 Years
Registered intervention description36 Weeks Methylprednisolone: Participants in 36 weeks of glucocorticoid treatment group will receive methylprednisolone, 48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 20 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal. Participants in 36 weeks of glucocorticoid treatment group also will receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA).The total treatment duration will be 36 weeks. Follow-up duration is 24 weeks. 48 weeks Methylprednisolone: Participants in 48 weeks of glucocorticoid treatment group will receive methylprednisolone, 48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in...
Registered arm groups36 Weeks Methylprednisolone, 48 Weeks Methylprednisolone
Phase IIb Study of Intranasal Glutathione in Parkinson's Disease
NCT02424708 · PHASE2 · COMPLETED · Parkinson's Disease · 21 Years
Registered intervention descriptionReduced Glutathione 100mg: 100mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Reduced Glutathione 200mg: 200mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
Registered arm groupsReduced Glutathione 100mg, Reduced Glutathione 200mg
Whey Protein Supplementation in Cancer Patients
NCT02065726 · NA · COMPLETED · Solid Tumors · 18 Years
Registered intervention descriptionNutritional counseling: Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
Registered arm groupsNutritional counseling
Methionine Metabolism in Parenterally Fed Pediatric Sepsis
NCT01891682 · COMPLETED · Sepsis, Critical Illness · 1 Month · 19 Years
Registered intervention descriptionObservational: Observational, Translational non-treatment study
Registered arm groupsCritically Ill Pediatric Patients
The Effects of a Glutathione Precursor (FT061452),on Serum and Intracellular Glutathione Levels
NCT01251315 · PHASE1 · COMPLETED · Oxidative Stress · 30 Years · 65 Years
Registered intervention descriptionPlacebo low dose: This is a prospective randomized controlled pilot study, which will include twenty-four (24) healthy individuals.The first 12 subjects (low dose) will be randomized into three sub groups. The first group will be given a single dose of placebo. N Acetyl cysteine, 600mg (low dose): The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC). Proimmune 200 (FT061452) 3000mg low dose: The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low dose' Placebo (high dose): The second sub set of 12 subjects (high dose) will be randomized into three sub groups. The first group will be given a single dose of placebo. N Acetyl...
Registered arm groupsPlacebo low dose, N Acetyl cysteine, 600mg (low dose), Proimmune 200(FT061452), Placebo high dose, N Acetyly cysteine, 1200mg (high dose), FT061452, 6000mg high dose
Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity
NCT00811083 · PHASE1, PHASE2 · COMPLETED · Autism · 3 Years · 8 Years
Registered intervention descriptionDMSA - dimercaptosuccinic acid: dose of 10 mg/kg bodyweight 3 doses/day, for 3 days, followed by 11 days off
Registered arm groupsDMSA- 1 round, DMSA-7 rounds
Immune Restoration by Lipoic Acid in AIDS
NCT00033176 · PHASE2 · COMPLETED · Acquired Immunodeficiency Syndrome, HIV Infections · 18 Years
Registered intervention descriptionAlpha Lipoic Acid
Registered study designHCG FET-LET-2x2: Clinical Pregnancy Rates After Frozen Embryo Transfer in Natural and Modified Natural Cycles
NCT07425990 · NA · NOT_YET_RECRUITING · Infertility Female, Frozen Embryo Transfer (FET) · 18 Years · 40 Years
Registered intervention descriptionChoriogonadotropin alpha (r-hCG): Recombinant human chorionic gonadotropin (hCG) 250 mcg administered subcutaneously to trigger ovulation when follicular and endometrial criteria are met.
Progesterone: Luteal phase support with either vaginal progesterone 200 mg twice daily or subcutaneous progesterone 25 mg once daily, initiated after ovulation (or 2 days after hCG trigger) and continued until 12 weeks of gestation if pregnancy occurs.
Registered arm groupsModified Natural Cycle With Letrozole, Modified Natural Cycle Without Letrozole, True Natural Cycle With Letrozole, True Natural Cycle Without Letrozole
Registered study designHCG Sleep Quality and the Menstrual Cycle
NCT06906133 · ACTIVE_NOT_RECRUITING · Sleep Quality · 18 Years · 36 Years
Registered intervention descriptionUrinary-hCG: Ovulation days will be detected using a commercial urine test for luteinizing hormone (LH) (PREGMATE, Ovulation Midstream Test Predictor Kit; sensitivity level:25mlU/mL). Participants will be instructed to use ovulation tests, starting 5 days before the expected ovulation (day 10) and for the next 7-10 days or until the first the first positive results are detected notify the study co-ordinator and share a photo of the results. Then participants will be asked to continue using the ovulation test for 3 more days.
Registered arm groups30 women using hormonal contraceptives, 30 women with natural cycle
Registered study designHCG Histopathological, Biochemical And Electrophysiological Evaluation Of Single Or Combined Use Of Diode Laser/Steroid Treatment On Facial Nerve Injury
NCT06185426 · EARLY_PHASE1 · UNKNOWN · Nerve Injury, Laser Therapy, Methylprednisolone · 4 Months · 6 Months
Registered intervention descriptionMethyprednisolon and low level laser theraphy: All rats will be anesthetized with ketamine hydrochloride at a dose of 50 mg/kg (i.p) (Ketalar ®, Eczacıbaşı Parke-Davis, İstanbul, Türkiye) and Xylazine HCl (Alfazyne ®, Alfasan International B.V. Woerden, Hollanda) at a dose of 10 mg/kg (intraperitoneal). A right postauricular incision will made under general anesthesia, and an external trunk of the facial nerve will be found. In the DCG and other experimental groups, the facial nerve was dissected, and it will be clamped with an average force of 150 g for about 1 minute. Afterward, the surgical area will be sutured in all rats in the DCG, L, S, and LSG groups. At the end of the 4 weeks of study, tissue samples will be taken from...
Registered arm groupsDamaged Control Group (DCG):, Healthy Control Group (HCG), Laser Group (LG), Laser+Steroid Group (LSG):, Steroid group (SG)
Registered study designHCG Detection of Urinary Human Chorionic Gonadotropin (hCG)
NCT05458778 · UNKNOWN · Pregnancy Detection · 18 Years · 80 Years
Registered intervention descriptionDaily test with urine by the product: Women perform the hCG test and share the test results
Registered arm groupsWomen who are trying to conceive
Registered study designHCG Natural Versus Programmed Frozen Embryo Transfer (NatPro)
NCT04551807 · PHASE3 · ACTIVE_NOT_RECRUITING · Pregnancy Related, Pre-Eclampsia · 18 Years · 41 Years
Registered intervention descriptionModified natural cycle: This treatment protocol is defined as a modified natural cycle as the participant will be instructed to (1) administer human chorionic gonadotropin (hCG) to assist with timing of the embryo transfer and (2) supplement the luteal phase with a low dose of progesterone.
Registered arm groupsModified natural cycle
Registered study designHCG GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET
NCT04064840 · PHASE3 · RECRUITING · Subfertility · 18 Years · 42 Years
Registered intervention descriptionIVF: Decapeptyl and hCG: When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and decapeptyl 0.2mg will be injected subcutaneously.
IVF: hCG and normal saline: When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and normal saline will be injected subcutaneously.
Registered arm groupsIVF: dual trigger, IVF: hCG trigger
Registered study designHCG The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
NCT03457233 · NA · UNKNOWN · Invitro Fertilization · 20 Years · 44 Years
Registered intervention descriptionGonadotropins: 1\) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
GNRH antagonist: cetrorelix 0,25mg s.c is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
Human chorionic gonadotropin Chorimon: 10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
Natural progesterone: 400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
Registered arm groupsNormal weight, Obese, Overweight
Registered study designHCG Study of Brentuximab Vedotin And Bevacizumab In Refractory CD-30 Positive Germ Cell Tumors
NCT02988843 · PHASE2 · TERMINATED · Germ Cell Tumor · 18 Years
Registered intervention descriptionBrentuximab Vedotin: Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)
Bevacizumab: 15 mg/kg every 21 days
Registered arm groupsBrentuximab Vedotin & Bevacizumab
Registered study designHCG Evaluation of Different Luteal Phase Support Methods in Patients With Poor Ovarian Response
NCT02798653 · PHASE3 · UNKNOWN · Infertility · 40 Years · 52 Years
Registered intervention descriptionChoriomon® injection: Intramuscular injection of 1,500 IU of hCG (Choriomon®; IBSA) on the embryos transfer (ET) day, as well as 4 days after the embryos transfer for luteal support
Choriomon® injection+Endometrin ®: Intramuscular injection of 1,500 IU of hCG (Choriomon®; IBSA) on the ET day, as well as 3 and 6 days after the transfer along with Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.
Registered arm groupsChoriomon®, Choriomon®+Endometrin ®
Registered study designHCG GnRH Agonist Triggering Supplemented With Hcg in Women With Poor Ovarian Response
NCT02144818 · NA · UNKNOWN · Women With Poor Ovarian Response · 18 Years · 45 Years
Registered intervention descriptionOvitrel: Triggering of ovulation with Ovitrel
Decapeptyl: Triggering with GnRH agonist
Registered arm groupsdual triggering: GnRH agonist and hCG, hCG, GnRH agonist
Registered study designHCG A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
NCT01497197 · PHASE3 · TERMINATED · Infertility, Fertility, Follicle Stimulating Hormone Deficiency · 36 Years · 42 Years
Registered intervention descriptionRecombinant human chorionic gonadotropin (r-hCG): A single injection of r-hCG (Ovidrel®/Ovitrelle®) 250 mcg to induce final oocyte maturation.
Registered arm groupsGonal-f® Followed by Luveris®, Gonal-f®+Luveris®
Registered study designHCG Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
NCT00947713 · PHASE1, PHASE2 · COMPLETED · Endocrine System Diseases, Gonadal Disorders · 18 Years · 30 Years
Registered intervention descriptionlow dose human chorionic gonadotropin: patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Registered arm groupsLow dose hCG group
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
NCT07678073 · NA · RECRUITING · Kidney Disease, End-Stage, Kidney Transplant, Kidney · 18 Years · 70 Years
Registered intervention descriptionSevoflurane General Anesthesia: Participants will receive standardized sevoflurane general anesthesia according to institutional kidney transplantation protocols. Anesthesia induction will include preoxygenation with 100% oxygen for 3-5 minutes, followed by intravenous propofol (1.5-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium bromide (0.6 mg/kg). Endotracheal intubation will be performed after short mask ventilation using direct laryngoscopy, and correct placement will be confirmed by auscultation. Anesthesia maintenance will be provided with sevoflurane (1.5-2.0% end-tidal) in a 40-50% oxygen/air mixture and remifentanil infusion (0.05-0.2 µg/kg/min). Mechanical ventilation will be set to 6-8 mL/kg tidal volume, PEEP 5 cmH₂O, and end-tidal CO₂ 35-40 mmHg. At the end of surgery, sevoflurane will be discontinued, neuromuscular blockade will be reversed with sugammadex (2-4 mg/kg), and extubation will be performed after recovery. Postoperative analgesia...
Registered arm groupsSevoflurane General Anesthesia (SGA), Combined Spinal-Epidural Anesthesia (CSEA)
How Are the Muscles Affected in Cerebral Palsy? A Study of Muscle Biopsies Taken During Orthopaedic Surgery.
NCT05506228 · RECRUITING · Cerebral Palsy, Muscle, Muscle Contracture · 2 Years · 18 Years
Registered intervention descriptionNo intervention
Registered arm groupsCerebral Palsy (CP) / Acquired Brain Injury (ABI), TD (Typically Developed)
Trifecta Research Study
NCT07717866 · ACTIVE_NOT_RECRUITING · PTSD - Post Traumatic Stress Disorder, Cognitive Dysfunction, Brain Injury · 18 Years
Registered intervention descriptionPhysiological Supplementation: Physiological Supplementation describes a treatment program aimed at restoring healthy endocrine functioning, using supplements such as the following: Synthetic testosterone, Anastrozole, Gonadorelin, Vitamin and amino acid supplementation, Fish oil, Ipamorelin.
Registered arm groupsIntervention Sequence 1, Intervention Sequence 2
Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function
NCT01280344 · PHASE2 · COMPLETED · Gastrointestinal Dysmotility · 18 Years · 85 Years
Registered intervention descriptionIpamorelin: Intravenous (IV)
Registered arm groups0.03 mg/kg BID, 0.06 mg/kg BID, 0.06 mg/kg TID
Safety and Efficacy of Ipamorelin for Management of Post-Operative Ileus
NCT00672074 · PHASE2 · COMPLETED · Ileus · 18 Years · 85 Years
Registered intervention descriptionIpamorelin: IV
Registered arm groups1 Ipamorelin
Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
NCT05456854 · PHASE1 · WITHDRAWN · Metabolic Disease · 18 Years · 40 Years
Registered intervention descriptionKisspeptin-10: Administration of kisspeptin-10 \* 16 hr
Registered arm groupsKisspeptin
Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
NCT04532801 · PHASE1 · WITHDRAWN · Insulin, Glucose, Healthy Volunteers · 18 Years · 40 Years
Registered intervention descriptionKisspeptin-10: kisspeptin-10 IV infusion
Registered arm groupskisspeptin-10
KP-10 and Insulin Secretion in Men
NCT03771326 · PHASE3 · COMPLETED · Kisspeptin Action on Insulin in Healthy Normal Men, Kisspeptin Action on Insulin in Obese Diabetic Men · 20 Years · 45 Years
Registered intervention descriptionKisspeptin-10: Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
Registered arm groupsNormal men, obese men
Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men
NCT03315325 · PHASE3 · COMPLETED · Sterility, Reproductive · 25 Years · 75 Years
Registered intervention descriptionHuman kisspeptin-10 (metastin 45-54): Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.
Registered arm groupsAdult men, Advance age men, Middle age men
Link Between the Sensitivity of Kisspeptin Signalling and Pubertal Onset in Boys.
NCT03286517 · PHASE3 · COMPLETED · Reproductive Physiological Phenomena
Registered intervention descriptionKisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany): A neurohormone
Registered arm groupsAdult Group, Tanner Stage I, Tanner Stage II, Tanner Stage III, Tanner Stage IV, Tanner stage V
Registered study designLL-37 Peri-implant Vitamin D and Cathelicidin (LL-37) Levels
NCT06867250 · COMPLETED · Peri-Implantitis and Peri-implant Mucositis · 18 Years
Registered intervention descriptionThe patients' periodontal clinical parameters were recorded. PISF samples were collected, and the evaluations of 25(OH)D and LL-37 were conducted using enzyme-linked immunosorbent assay.: In vitro studies have shown that vitamin D promotes the release of antimicrobial peptides from gingival epithelial cells, no clinical research has specifically examined its effect on LL-37 levels in peri-implant tissue diseases. This study seeks to investigate the relationship between vitamin D levels in peri-implant sulcus fluid and clinical parameters in individuals with both peri-implant health and disease. Additionally, it aims to assess the correlation between vitamin D and the antimicrobial peptide LL-37.
Registered arm groupsperi-implant healthy, peri-implant mucositis, peri-implantitis
Registered study designLL-37 Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels
NCT04946617 · UNKNOWN · Mouth and Tooth Diseases, Periodontal Diseases, Gingivitis · 25 Years · 40 Years
Registered intervention descriptionundefined: Rinsing with mouthwashes
Registered arm groupsCP group, G group, H group
Registered study designLL-37 The Role of Anti-inflammatory Cytokines and Antimicrobial Peptide LL-37 Biomarkers in the Treatment of Periodontal Disease.
NCT04404335 · COMPLETED · Periodontal Diseases, Periodontitis · 18 Years
Registered intervention descriptionCrevicular fluid analysis by using ELISA testing.: Samples of crevicular fluid (fluid existing in the space between the gums and the roots of the teeth) will be obtained from healthy and periodontal patients. In periodontal patients, samples will be taken before and after receiving a routine course of periodontal treatment (root scale and polish) to assess the levels of a peptide called LL-37 and inflammatory cytokines (IL-4, IL-6, IL-10): Samples will then be analysed using laboratory procedures (ELISA)
Registered arm groupsHealthy (control group), Periodontitis (test group)
Registered study designLL-37 Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children
NCT04292548 · COMPLETED · Passive Smoking, Oxidative Stress, Dental Caries · 6 Years · 12 Years
Registered intervention descriptiontaking saliva samples to determine TAS, TOS and LL-37
Registered arm groupscontrol group, study group (passive smoking children)
Registered study designLL-37 Efficacy of LL-37 Cream on Bacteria Colonization, Inflammation Response and Healing Rate of Diabetic Foot Ulcers
NCT04098562 · PHASE2 · UNKNOWN · Diabetic Foot Ulcer · 18 Years · 60 Years
Registered intervention descriptionLL37: cream
Registered arm groupsTreatment
Registered study designLL-37 Effects of Smoking and Vitamin D3 on the Levels of Human Cathelicidin Peptide LL-37
NCT03923218 · COMPLETED · Periodontitis · 35 Years · 50 Years
Registered intervention descriptionLL-37 levels in Gingival crevicular fluid: Collected gingival crevicular fluid
Registered arm groupsSmoker patients with chronic periodontitis, non-smoker patients with chronic periodontitis, periodontally healthy patients
Registered study designLL-37 Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
NCT01689441 · PHASE2 · COMPLETED · Severe Sepsis or Septic Shock · 18 Years
Registered intervention descriptionCalcitriol
Placebo
Registered arm groupsCalcitriol, Placebo
Registered study designLL-37 Clinical Trial of Phenylbutyrate and Vitamin D in Tuberculosis (TB)
NCT01580007 · PHASE2 · COMPLETED · Pulmonary Tuberculosis · 18 Years · 60 Years
Registered intervention descriptionActive Sodium Phenylbutyrate and active cholecalciferol: Sodium Phenylbutyrate: 500 mg twice daily orally for 2 months Cholecalciferol: 5000 IU once daily orally for 2 months
Placebo Sodium Phenylbutyrate plus active cholecalciferol: Placebo Sodium Phenylbutyrate: twice daily orally for 2 months Cholecalciferol: 5000 IU once daily for 2 months
Active Sodium Phenylbutyrate and placebo cholecalciferol: Sodium phenylbutyrate: 500 mg twice daily orally for 2 months Placebo cholecalciferol: once daily orally for 2 months
Placebo Sodium Phenylbutyrate plus placebo cholecalciferol: Placebo Sodium Phenylbutyrate: twice daily orally for 2 months Placebo cholecalciferol: once daily orally for 2 months
Registered arm groupsActive Sodium Phenylbutyrate and active cholecalciferol, Placebo Sodium Phenylbutyrate plus active cholecalciferol, Active Sodium Phenylbutyrate and placebo cholecalciferol, Placebo Sodium Phenylbutyrate plus placebo cholecalciferol
Registered study designLL-37 hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease
NCT01026363 · NA · WITHDRAWN · Chronic Kidney Disease, Vitamin D Deficiency · 18 Years · 80 Years
Registered intervention descriptionErgocalciferol: Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses
Calcitriol: 0.25 mcg tablet once daily for 14 days
Registered arm groupsergocalciferol, calcitriol
Registered study designLL-37 Therapeutic Induction of Endogenous Antibiotics
NCT00800930 · PHASE2 · COMPLETED · Shigellosis · 18 Years · 55 Years
Registered intervention descriptionSodium Butyrate: Patients will be instructed to lie on a bed (cholera cot) in left lateral position. A soft rectal catheter will be introduced by a nurse/physician, through which 80 ml of butyrate solution will be instilled slowly with a 50 ml plastic syringe. Patients will be asked to retain the enema for at least ½ hour by remaining supine for 30 minutes after the administration. However, if a patient cannot retain the enema for 30 minutes, he will be given a second round of enema immediately after defecation. Saline: Patients will be instructed to lie on a bed (cholera cot) in left lateral position. A soft rectal catheter will be introduced by a nurse/physician, through which 80 ml of saline solution will be instilled...
Registered arm groups1, 2
Registered study designLL-37 Vitamin D in Active Tuberculosis (TB) Study
NCT00788320 · NA · WITHDRAWN · Tuberculosis · 18 Years
Registered intervention descriptionVitamin D3: Vitamin D3 50,000 IU three times a week for 8 weeks
Placebo: Placebo three times a week for 8 weeks
Registered arm groupsCholecalciferol, Placebo
Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo
NCT07437560 · PHASE2 · RECRUITING · NonSegmental Vitiligo, Nonsegmental Vitiligo (Stable) · 18 Years · 65 Years
Registered intervention descriptionMelanotan II (MT-II): administered per protocol
Registered arm groupsMelanotan II + NB-UVB phototherapy, Placebo + NB-UVB phototherapy
Comparison of the Effects of General Anesthesia and Combined Spinal-Epidural Anesthesia on Ferroptosis, Humanin and MOTS-c Levels in Renal Transplantation
NCT07678073 · NA · RECRUITING · Kidney Disease, End-Stage, Kidney Transplant, Kidney · 18 Years · 70 Years
Registered intervention descriptionSevoflurane General Anesthesia: Participants will receive standardized sevoflurane general anesthesia according to institutional kidney transplantation protocols. Anesthesia induction will include preoxygenation with 100% oxygen for 3-5 minutes, followed by intravenous propofol (1.5-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium bromide (0.6 mg/kg). Endotracheal intubation will be performed after short mask ventilation using direct laryngoscopy, and correct placement will be confirmed by auscultation. Anesthesia maintenance will be provided with sevoflurane (1.5-2.0% end-tidal) in a 40-50% oxygen/air mixture and remifentanil infusion (0.05-0.2 µg/kg/min). Mechanical ventilation will be set to 6-8 mL/kg tidal volume, PEEP 5 cmH₂O, and end-tidal CO₂ 35-40 mmHg. At the end of surgery, sevoflurane will be discontinued, neuromuscular blockade will be reversed with sugammadex (2-4 mg/kg), and extubation will be performed after recovery. Postoperative analgesia...
Registered arm groupsSevoflurane General Anesthesia (SGA), Combined Spinal-Epidural Anesthesia (CSEA)
MOTS-c for Improving Insulin Sensitivity in Adults With Prediabetes and Overweight/Obesity
NCT07505745 · PHASE2 · RECRUITING · Prediabetes, Insulin Resistance, Overweight/Obesity · 18 Years · 65 Years
Registered intervention descriptionMOTS-c (MDP): Drug: MOTS-c (MDP)
Registered arm groupsMOTS-c
Registered study designNAD+ Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging
NCT07774000 · NA · RECRUITING · Skin Aging on Face, Skin Care Dermocosmetics, Skin Care · 30 Years · 60 Years
Registered intervention descriptionTopical niacinamide riboside: Niacinamide chloride (NR) prepared in a dry nanofiber pillow will be applied to the skin using a standardized gel serum twice daily, for 12 weeks. NR is a precursor to the essential cellular co-enzyme, NAD+, which has been directly associated with the molecular hallmarks of aging.
Registered arm groups10% NR, 2.5% NR, 5% NR
Registered study designNAD+ Renewal-NAD+: A Study of Oral NAD+ and Its Multi-omic Impact in a Healthy Cohort
NCT07336836 · EARLY_PHASE1 · COMPLETED · Health Adult Subjects, Healthy Participants · 45 Years · 75 Years
Registered intervention descriptionLathMized TM NAD+ (LNAD+): NAD+ 500 mg
Registered arm groupsTreatment arm
Registered study designNAD+ Nicotinamide Supplementation Improves Physical Performance in Older Adults at Risk of Falls
NCT06465602 · PHASE2 · UNKNOWN · Frailty, Fall, Frailty Syndrome · 65 Years
Registered intervention descriptionNicotinamide: The subjects will receive 1.5 grams per day of Nicotinamide, orally, for 30 days.
Placebo: The subjects will receive 1.5 grams per day of placebo, orally, for 30 days.
Registered arm groupsNicotinamide supplementation group, Placebo group
Registered study designNAD+ The Exploratory Study on the Nicotinamide Mononucleotide (Vital NAD ) to Promote the Rejuvenation of the Peripheral Blood Immune Cells of Adults.
NCT05984550 · EARLY_PHASE1 · UNKNOWN · Enhance Immune Function · 18 Years · 80 Years
Registered intervention descriptionNMN: NMN (Nicotinamide Mononucleotide) is a naturally occurring bioactive nucleotide with the full name of Nicotinamide mononucleotide. Its structure can be divided into α and β Two isomers, of which only β- NMN is a naturally occurring form with biological activity.
In human body, NMN is the precursor of NAD+(Nicotinamide adenine dinucleotide, also known as coenzyme I), and its function is mainly reflected through NAD+.
Registered arm groupstreated group
Registered study designNAD+ Effect of NMN on Muscle Recovery and Physical Capacity in Healthy Volunteers With Moderate Physical Activity
NCT04664361 · NA · COMPLETED · Physical Activity, Muscle Recovery · 20 Years · 49 Years
Registered intervention descriptionPlacebo: Daily supplementation with placebo for 38 days in total
Registered arm groupsPlacebo
Emotional Eating — Dosage and Administration
Dr. Donna Restivo DC · ORAL
Source-supplied dosage sectionDIRECTIONS: 3-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.
Pre-approval Expanded Access of Retatrutide (LY3437943)
NCT07629401 · AVAILABLE · Obesity, Obesity-related Complications · 18 Years
Registered intervention descriptionRetatrutide
Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight
NCT07467447 · PHASE2 · RECRUITING · Obesity · 18 Years · 75 Years
Registered intervention descriptionRetatrutide (LY3437943): subcutaneous injection, once weekly (dose per assigned arm).
Registered arm groupsPlacebo once weekly (matched escalation schedule to maintain blinding)., Retatrutide (LY3437943) 1 mg once weekly (no escalation), Retatrutide 12 mg once weekly: 2 mg → 4 mg → 8 mg → 12 mg., Retatrutide 4 mg once weekly, escalation subgroup (a): 2 mg → 4 mg., Retatrutide 4 mg once weekly, subgroup (b): start 4 mg (no escalation)., Retatrutide 8 mg once weekly, subgroup (a): 2 mg → 4 mg → 8 mg, Retatrutide 8 mg once weekly, subgroup (b): 4 mg → 8 mg.
A Study of Retatrutide (LY3437943) in Participants Without Type 2 Diabetes Who Have Obesity or Overweight
NCT07357415 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity, Overweight · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose Escalation 1, Retatrutide Dose Escalation 2, Retatrutide Dose Escalation 3
A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight
NCT07232719 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity, Overweight · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 2
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
NCT07165028 · PHASE3 · RECRUITING · Metabolic Dysfunction-Associated Steatotic Liver Disease · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide (RT01)
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
NCT07035093 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity, Overweight, Chronic Low Back Pain (CLBP) · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide
A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
NCT06982846 · PHASE1 · COMPLETED · Type 2 Diabetes Mellitus · 18 Years · 70 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide
A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus
NCT06982859 · PHASE1 · ACTIVE_NOT_RECRUITING · Diabetes Mellitus, Insulin Sensitivity · 18 Years · 70 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide
A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity
NCT06859268 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 1 to Placebo, Retatrutide Dose 1 to Retatrutide Dose 2
To Investigate the Effect of Retatrutide (LY3437943) on Metoprolol Pharmacokinetics in Healthy Participants
NCT06808802 · PHASE1 · COMPLETED · Healthy · 21 Years · 65 Years
Registered intervention descriptionRetatrutide: Administered subcutaneously (SC)
Registered arm groupsRetatrutide
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
NCT06662383 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
NCT06383390 · PHASE3 · ACTIVE_NOT_RECRUITING · Atherosclerotic Cardiovascular Disease (ASCVD), Chronic Kidney Disease (CKD) · 45 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide
Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)
NCT06354660 · PHASE3 · COMPLETED · Diabetes Type 2 · 18 Years
Registered intervention descriptionRetatrutide: Administered SC.
Registered arm groupsRetatrutide Dose Level 1, Retatrutide Dose Level 2, Retatrutide Dose Level 3
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
NCT06297603 · PHASE3 · ACTIVE_NOT_RECRUITING · Type 2 Diabetes · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 2, Retatrutide Dose 3
Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)
NCT06260722 · PHASE3 · ACTIVE_NOT_RECRUITING · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionRetatrutide: Administered SC.
Registered arm groupsRetatrutide Dose Level 1, Retatrutide Dose Level 2
A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes
NCT05936151 · PHASE2 · COMPLETED · Overweight or Obesity, CKD, Type 2 Diabetes · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
NCT05931367 · PHASE3 · COMPLETED · Obesity, Overweight, Osteo Arthritis Knee · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 2
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
NCT05929079 · PHASE3 · COMPLETED · Type 2 Diabetes, Obesity, Overweight · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 2, Retatrutide Dose 3
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
NCT05929066 · PHASE3 · COMPLETED · Obesity, Overweight, Osteoarthritis, Knee · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 2, Retatrutide Dose 3, Retatrutide Extension Period
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
NCT05882045 · PHASE3 · COMPLETED · Obesity, Cardiovascular Diseases · 18 Years
Registered intervention descriptionRetatrutide: Administered SC
Registered arm groupsRetatrutide Dose 1, Retatrutide Dose 2
Optimizing Albuminuria Treatment in CKD With Finerenone and Semaglutide
NCT07819227 · PHASE2 · COMPLETED · Chronic Kidney Disease · 18 Years
Registered intervention descriptionSemaglutide 14 MG [Rybelsus]: 14 mg once daily (registered maximum dose, up-titrate from 3 mg and 7 mg once daily). Dose modifications in case of occurrence of side-effects will be carried out according to the investigator's discretion. Oral tablet.
Finerenone and Semaglutide: After 4 weeks of maximum tolerated semaglutide, participants will receive combined oral finerenone and semaglutide for 6 weeks. The procedures during the 6 weeks treatment period are the same as those during the finerenone only treatment periods. Because the combination treatment period immediately follows the semaglutide monotherapy treatment period, no additional titration of semaglutide is necessary. During the combination treatment period, the dose of finerenone will be uptitrated after 2 weeks in patients with eGFR ≥60 mL/min/1.73m2 and serum potassium ≤5.0 mmol/L.
Registered arm groupsTreatment order 1, Treatment order 2
Ozempic — Dosage and Administration
NDA209637 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION • Administer once weekly at any time of day, with or without meals. ( 2.1 ) • Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly. ( 2.2 ) • If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose. ( 2.2 ) • If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage. ( 2.2 ) • To reduce the risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death, increase the dosage to 1 mg once weekly after at least 4 weeks...
A Study of BGM0504 in Early T2DM With Obesity
NCT07743983 · PHASE3 · RECRUITING · Type 2 Diabetes (T2DM) · 18 Years · 75 Years
Registered intervention descriptionsemaglutide: Administered as a subcutaneous injection once weekly for 52 weeks.
Registered arm groupsSemaglutide Injection 1.0 mg
Semaglutide and Structured Lifestyle Support to Improve Heart and Blood Vessel Health in Postmenopausal Obese Breast Cancer Survivors Taking Aromatase Inhibitors
NCT07769047 · PHASE4 · NOT_YET_RECRUITING · Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8 · 46 Years · 55 Years
Registered intervention descriptionSemaglutide: Given SC
Registered arm groupsArm II (LM+Sema)
Effects of GLP-1 RAs on Human Lactation Outcomes
NCT07720414 · RECRUITING · Lactation, Weight Loss
Registered intervention descriptionInjected GLP-1 Receptor Agonists and Dual Agonists: Participants are prescribed this medication by their care provider(s) as part of their postnatal clinical care, including but not limited to semaglutide and tirzepatide. The investigators do not provide, manage, or assign the medication.
Registered arm groupsBreastfeeding mothers prescribed GLP-1 RA therapies
Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults
NCT07754045 · PHASE2 · NOT_YET_RECRUITING · Obesity & Overweight · 60 Years · 84 Years
Registered intervention descriptionLUM-201: Daily (AM) oral Tablet at 25 mg
Placebo: Daily (AM) oral Tablet
Semagludtide: Daily (AM) oral Tablet
Registered arm groupsLUM-201 plus Semaglutide, Semaglutide plus placebo
Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity
NCT07701005 · COMPLETED · Steatosis of Liver, Metabolic Liver Injury, Obesity · 18 Years · 75 Years
Registered intervention descriptionSemaglutide: Once-weekly subcutaneous GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
Registered arm groupsSemaglutide
BALANCE-DM2 Study of Bofanglutide in Adults With Type 2 Diabetes
NCT07628985 · PHASE3 · NOT_YET_RECRUITING · Type 2 Diabetes Mellitus (T2DM) · 18 Years
Registered intervention descriptionSemaglutide: GLP-1 receptor agonist administered as a weekly subcutaneous injection with dose escalation from 0.25 mg up to 1 mg according to the study protocol.
Registered arm groupsArm 2: Semaglutide
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
NCT07592546 · PHASE4 · NOT_YET_RECRUITING · Class I/II Obesity · 35 Years · 55 Years
Registered intervention descriptionsemaglutide: Treatment will be given for 80 weeks. Dose will be escalated from 0.25 mg to a max of 2.4 mg per week.
Registered arm groupsOverweight Group (BMI 27 - 40 kg/m2)
OZEMPIC — Dosage and Administration
NDA213051 · Novo Nordisk Pharmaceutical Industries, LP · ORAL
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION • RYBELSUS and OZEMPIC tablets are not substitutable on a mg-to-mg basis. • Take RYBELSUS or OZEMPIC tablets orally once daily on an empty stomach in the morning with water (up to 4 ounces of water); do not take with other liquids besides water. ( 2.1 ) • Swallow tablets whole. Do not split, crush, chew or dissolve in any solution. ( 2.1 ) • After taking RYBELSUS or OZEMPIC tablets, wait at least 30 minutes before eating food, drinking beverages or taking other oral medications. ( 2.1 ) • See the Full Prescribing Information for instructions on switching between RYBELSUS and OZEMPIC tablets ( 2.3 ) and from OZEMPIC injections to RYBELSUS or OZEMPIC tablets. ( 2.4 ) Recommended Starting,...
Effects of Semaglutide on Clinical Outcomes and Metabolic Inflammation in Psoriasis
NCT07401992 · PHASE4 · RECRUITING · Psoriasis (PsO), Obesity & Overweight, Diabetes Mellitus - Type 2 · 18 Years
Registered intervention descriptionSemaglutide (Rybelsus®): Oral semaglutide will be administered once daily at a dose of 3 mg for the first 4 weeks, followed by 7 mg once daily for the next 4 weeks, and 14 mg once daily for the final 4 weeks (total treatment duration: 12 weeks). All participants will also receive conventional topical therapy for 12 weeks, consisting of a topical corticosteroid and a vitamin D analog (calcipotriol).
Registered arm groupsSemaglutide group
Bariatric Surgery Combined With GLP-1 Receptor Agonists Study
NCT07336862 · PHASE1, PHASE2 · RECRUITING · Obesity · 18 Years · 60 Years
Registered intervention descriptionBS-GLP group: 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the intervention group received subcutaneous semaglutide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, semaglutide treatment was initiated at 1 month after LSG. The starting dose was 0.25 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 2.4 mg per week. The treatment continued...
Registered arm groupsBS-GLP group
A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
NCT07011667 · PHASE3 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years
Registered intervention descriptionCagriSema (Cagrilintide B and Semaglutide I): CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I): Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Registered arm groupsCagriSema, Placebo
Protein Supplementation Intervention on Body Weight
NCT06989203 · NA · RECRUITING · Obesity, Weight Loss, Protein Supplementation · 20 Years · 50 Years
Registered intervention descriptionsemaglutide: Participants will receive semaglutide as medically prescribed
Registered arm groupsCRD+GLP-1RA, CRD+GLP-1RA+HP
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
NCT06897475 · PHASE2 · RECRUITING · Type 2 Diabetes · 18 Years · 75 Years
Registered intervention descriptionLY3457263: Administered SC
Placebo: Administered SC
Registered arm groupsLY3457263 Dose 1, LY3457263 Dose 2, LY3457263 Dose 3, Placebo
Sleeve Gastrectomy vs. Lifestyle & Medications: Impact on BMI Trajectory and Target Attainment in a Matched Cohort Study
NCT06820047 · COMPLETED · Obesity and Obesity-related Medical Conditions · 19 Years · 69 Years
Registered intervention descriptionObesity pharmacotherapy: Patients underwent 1 month of a very low calorie diet (VLCD) with 813 kcal/day, followed by a low calorie diet (LCD) for 11 months together with intensive physical exercise (30 min/day of brisk walking plus at least 3 h/week of aerobic exercise) with 2.4 mg/week of semaglutide (Ozempic®), given once weekly as subcutaneous injections. Patients were evaluated at baseline and at 1, 3, 6, 9 and 12 months after starting the interventions.
Registered arm groupsMedical Group
Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions
NCT06801015 · PHASE4 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years · 75 Years
Registered intervention descriptionSemaglutide: Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week
Registered arm groupssemaglutide
Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants
NCT06648031 · PHASE1 · COMPLETED · Type2diabetes · 18 Years · 65 Years
Registered intervention descriptionArm 2 - DehydraTECH-semaglutide alone: Dose: 3.5 mg once daily for 4 weeks, ascending to 7 mg once daily for the remaining 8 weeks. Route of administration: Oral Dosage form: Capsule
Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide: DehydraTECH-CBD dosing = 250 mg twice daily for 12 weeks.
\- DehydraTECH-semaglutide = 3.5 mg once daily for 12 weeks Route of administration: Oral Dosage form: Capsule
Arm 4 - Rybelsus medication (semaglutide) alone: Normal clinical dose of 3.0 mg once daily for 4 weeks, ascending to 7.0 mg once daily for the remaining 8 weeks. Route of administration: Oral Dosage form: Capsule
Registered arm groupsArm 2 - DehydraTECH-semaglutide alone, Arm 3 - DehydraTECH-CBD in combination with DehydraTECH-semaglutide, Arm 4 - Rybelsus medication (semaglutide) alone as a positive control.
Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2
NCT06396416 · PHASE4 · RECRUITING · Obesity, Chronic Kidney Disease · 18 Years
Registered intervention descriptionSemaglutide: Maximum tolerated dose of semaglutide subcutaneously once weekly. Maximum dose of 2.0 mg.
Registered arm groupsVirtual Weight Management Program
A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
NCT06388187 · PHASE3 · COMPLETED · Obesity · 18 Years
Registered intervention descriptionSemaglutide: Participants will receive once-weekly semaglutide subcutaneously.
Placebo: Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.
Registered arm groupsCagriSema Dose 1, CagriSema Dose 2, Placebo Dose 1, Placebo Dose 2
WEGOVY — Dosage and Administration
NDA215256 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION • Administer WEGOVY once weekly as an adjunct to diet and increased physical activity, on the same day each week, at any time of day, with or without meals (2.1). • Inject subcutaneously in the abdomen, thigh or upper arm (2.1). • In patients with type 2 diabetes, monitor blood glucose prior to starting and during WEGOVY treatment (2.1). • Initiate at 0.25 mg once weekly for 4 weeks. Then follow the dosage escalation schedule, titrating every 4 weeks to achieve the maintenance dosage (2.2 , 2.3). • The maintenance dosage of WEGOVY in adults is either 2.4 mg (recommended) or 1.7 mg once weekly (2.2) . • The maintenance dosage of WEGOVY in pediatric patients aged 12 years and older...
Study That Tests AD109 in Patients Taking GLP-1 Drugs
NCT06400615 · PHASE2 · COMPLETED · OSA · 18 Years · 75 Years
Registered intervention descriptionAD109: Oral administration at bedtime
Registered arm groupsArm 1, Arm 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin
NCT06323161 · PHASE3 · COMPLETED · Type 2 Diabetes · 18 Years
Registered intervention descriptionSemaglutide: Participants will receive once-weekly semaglutide subcutaneously.
Placebo: Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Registered arm groupsCagriSema Dose 1, CagriSema Dose 2, Placebo Dose 1, Placebo Dose 2
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
NCT06323174 · PHASE3 · COMPLETED · Type 2 Diabetes · 18 Years
Registered intervention descriptionSemaglutide: Participants will receive once-weekly semaglutide subcutaneously.
Placebo: Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Registered arm groupsCagriSema Dose 2, Cagrisema Dose 1, Placebo Dose 1, Placebo Dose 2
Ozempic — Dosage and Administration
NDA209637 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION • Administer once weekly at any time of day, with or without meals ( 2.1 ). • Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly ( 2.2 ). • If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose ( 2.2 ). • If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage ( 2.2 ). • If a dose is missed administer within 5 days of missed dose ( 2.2 ). • Inject subcutaneously in the abdomen, thigh, or upper arm ( 2.2...
OZEMPIC — Dosage and Administration
NDA209637 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION • Administer once weekly at any time of day, with or without meals ( 2.1 ). • Start at 0.25 mg once weekly. After 4 weeks, increase the dosage to 0.5 mg once weekly ( 2.2 ). • If additional glycemic control is needed, increase the dosage to 1 mg once weekly after at least 4 weeks on the 0.5 mg dose ( 2.2 ). • If additional glycemic control is needed, increase the dosage to 2 mg once weekly after at least 4 weeks on the 1 mg dosage ( 2.2 ). • If a dose is missed administer within 5 days of missed dose ( 2.2 ). • Inject subcutaneously in the abdomen, thigh, or upper arm ( 2.2...
A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range
NCT06041217 · PHASE3 · COMPLETED · Overweight, Obesity · 18 Years
Registered intervention descriptionSemaglutide: Subcutaneous injections of semaglutide once-weekly at escalating doses every fourth week until maintenance dose of 2.4 mg of semaglutide is reached.
Placebo: Subcutaneous injections of placebo once-weekly at escalation doses manner as semaglutide every fourth week until maintenance dose of placebo matched to 2.4 mg is reached.
Registered arm groupsSemaglutide 2.4 milligram (mg), Placebo
Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study
NCT05897372 · PHASE2 · TERMINATED · Diabetic Kidney Disease · 18 Years
Registered intervention descriptionACEi / ARB, SGLT2i, finerenone, semaglutide, pentoxifylline, hydrochlorthiazide, baricitinib: Standard of care for diabetic kidney disease.
Registered arm groupsAlbuminuria-reduction protocol, Standard of Care
O-SEMA-Fast: A Research Study to Understand How Oral Semaglutide Works in People With Type 2 Diabetes Who Plan to Fast During Ramadan in the United Arab Emirates, Saudi Arabia, and Kuwait
NCT05716724 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionSemaglutide: Participants will receive oral semaglutide with or without other OADs as per local label at the discretion of the treating physician and is clearly independent from the decision to include the participant in the study.
Registered arm groupsParticipants with T2D
A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP)
NCT05646706 · PHASE3 · COMPLETED · Obesity · 18 Years
Registered intervention descriptionSemaglutide: Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg) every fourth week. Treatment was continued on the maintenance dose of 7.2 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Semaglutide: Participants will receive once-weekly s.c. injections of semaglutide in escalating doses (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg) every fourth week. Treatment was continued on the maintenance dose of 2.4 mg once-weekly for an additional 52 weeks. Injections may be administered in the thigh, abdomen, or upper arm, at any time of day irrespective of meals. Placebo:...
Registered arm groupsSemaglutide 7.2 mg, Semaglutide 2.4 mg, Placebo
COMMETS- Combination MCI Metabolic Syndrome
NCT06072963 · PHASE2 · RECRUITING · Alzheimer Disease, Mild Cognitive Impairment, Metabolic Syndrome · 60 Years · 90 Years
Registered intervention descriptionSemaglutide: The medication is available in 3, 7, and 14-mg tablets for oral use. Participants will be instructed to start with an initiating dose of 3 mg once daily. If they do not experience adverse events (nausea, vomiting, and abdominal pain) then the dose will be titrated to 7 mg once daily after 30 days. Again, if the participant does not experience adverse events, the dose will be further titrated after 30 days to 14 mg once daily. This does will continue until the end of the study, at 12 months.
Semaglutide placebo: Rybelsus semaglutide - this medicine will simulate taking the pill Rybelsus /semaglutide once a day. A pill identical to the medicine pill will be given.
Registered arm groupsGroup 1, Group 3, Group 2, Group 4
Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome
NCT05586802 · PHASE3 · RECRUITING · Klinefelter Syndrome · 16 Years · 65 Years
Registered intervention descriptionSemaglutide: This will be an experimental treatment for 26 weeks in Group 2 Arm E
Registered arm groupsGroup 2 (Metabolic Risk) - randomized to Arm E
Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes
NCT05597202 · PHASE4 · UNKNOWN · Type 2 Diabetes · 50 Years
Registered intervention descriptionSemaglutide, 2.0 mg/mL: Semaglutide 2.0 mg/mL, administered subcutaneously once per week for a period of 6 months.
Registered arm groupsTreatment arm
Young Adults With Early-onset Obesity Treated With Semaglutide
NCT05574439 · PHASE4 · COMPLETED · Obesity, Adolescent · 18 Years · 28 Years
Registered intervention descriptionSemaglutide 3 mg/ml: Participants will be instructed to initiate at 0.24 mg SC once weekly for 4 weeks, and in 4 week intervals, increase the dose until a dose of 2.4 mg is reached. In case of prolonged side effects the dose may be adjusted to lower than 2.4mg/week.
Placebo (Semaglutide 3 mg/ml): Participants will be instructed to initiate at 0.24 mg SC once weekly for 4 weeks, and in 4 week intervals, increase the dose until a dose of 2.4 mg is reached. In case of prolonged side effects the dose may be adjusted to lower than 2.4mg/week.
Registered arm groupsInsufficient responders: TCOC+ semaglutide, Non-responders: TCOC+ semaglutide, Insufficient responders: TCOC+ placebo, Non-responders: TCOC+ placebo
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Finland, as Part of Local Clinical Practice
NCT05443191 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionSemaglutide: Participants will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the participant in this study.
Registered arm groupsSemaglutide
Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects.
NCT05419726 · RECRUITING · Obesity · 18 Years
Registered intervention descriptionSemaglutide Injectable Product (not provided by the study): Study Procedure:
Subjects that are to be started on semaglutide by their physician will be invited to participate in the study. If the subject is eligible and signs the consent form they will be enrolled in the study. There are three (3) study visits including Baseline/Visit 1 (prior to starting semaglutide), Visit 2 (at week 2-4) and Visit 3 (at week 18-20). The subjects undergo these tests at each visit: weight circumference measured, BMR testing, thermal imaging of BAT, and perform a 24 hour food recall.
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Weekly Insulin Icodec
NCT05352815 · PHASE3 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionIcoSema: Participants will receive once weekly IcoSema subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Insulin icodec: Participants will receive once weekly Insulin icodec subcutanously (s.c. under the skin) with or without oral anti diabetic drugs for 52 weeks.
Registered arm groupsIcoSema, Insulin icodec
Interest of GLP1 Analogues in Overweight Type 2 Diabetic Patients With Chronic Inflammatory Bowel Disease
NCT05196958 · NA · UNKNOWN · Inflammatory Bowel Diseases, Diabetes Mellitus, Type 2 · 18 Years · 75 Years
Registered intervention descriptionGLP1 analogues: This cohort study has 2 phases: an observation phase to collect all initial clinical and biological parameters and an intervention phase (prescription of GLP1 analogues) of 6 months including a visit at 3 and 6 months.
Registered arm groupsGLP1 analogues
BESTMED: Observational Evaluation of Second Line Therapy Medications in Diabetes
NCT05161429 · UNKNOWN · Diabetes Mellitus, Type 2 · 30 Years
Registered intervention descriptionGLP-1 receptor agonist: Glucagon-like peptide-1 receptor agonists (GLP1-RA) including dulaglutide, exenatide, liraglutide and semaglutide
Registered arm groupsGLP1-RA
Pharmacogenetics of Response to GLP1R Agonists
NCT05071898 · PHASE1 · RECRUITING · Obesity, Diabetes Type 2 · 18 Years · 89 Years
Registered intervention descriptionSemaglutide Pen Injector [Ozempic]: Participants will receive subcutaneously injected semaglutide (0.25 mg/wk) for 4 weeks followed by semaglutide (0.5 mg/wk) for an additional two weeks.
Registered arm groupsOpen label administration of semaglutide
Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care
NCT04938388 · PHASE4 · TERMINATED · Diabetes Mellitus, Type 2, Glucose Metabolism Disorders (Including Diabetes Mellitus) · 18 Years
Registered intervention descriptionSemaglutide Pill: All participants will start at a 3 mg dose of OS or matched Placebo. If this minimum dose is not tolerated, the participant will be withdrawn from the study. After 4 weeks, the OS dose (or Placebo) will be adjusted to 7 mg. After a further 4 weeks of study and thereafter, the OS dose (or Placebo) will be adjusted at the study physician's discretion to 14 mg. At each study visit, the current dose of OS (or Placebo) will be maintained, unless participants report moderate-to-severe nausea or vomiting for 3 or more days in the week before the scheduled visit.
Registered arm groupsOral Semaglutide (OS) with Enhanced Lifestyle Care (organic vegetables)
Semaglutide for the Reduction of Arrhythmia Burden in Overweight AF Patients
NCT04885634 · PHASE3 · WITHDRAWN · Atrial Fibrillation, Overweight and Obesity · 18 Years
Registered intervention descriptionSemaglutide Injectable Product: Subcutaneous injection of Semaglutide 2.4 mg once weekly
Registered arm groupsIntervention group
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)
NCT04777409 · PHASE3 · COMPLETED · Early Alzheimer´s Disease · 55 Years · 85 Years
Registered intervention descriptionSemaglutide: Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Placebo (semaglutide): Oral placebo (semaglutide) once-daily. The study will last for up to 173 weeks
Registered arm groupsOral semaglutide, Placebo (semaglutide)
Effect of Subcutaneous Semaglutide on Kidney Transplant Candidacy
NCT04741074 · PHASE3 · TERMINATED · CKD, Diabetic Kidney Disease, Type 2 Diabetes Mellitus in Obese · 18 Years
Registered intervention descriptionSemaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution: Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
Registered arm groupsSemaglutide
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Sweden, as Part of Local Clinical Practice
NCT04601753 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionOral Semaglutide: Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
Registered arm groupsPatients with type 2 diabetes
A Research Study to Compare a Medicine Called Semaglutide Against Placebo in People With Peripheral Arterial Disease and Type 2 Diabetes
NCT04560998 · PHASE3 · COMPLETED · Diabetes Mellitus, Type 2, Peripheral Arterial Disease · 18 Years
Registered intervention descriptionSemaglutide: Semaglutide is administered subcutaneously (s.c.; under the skin) once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
Placebo (semaglutide): Placebo (semaglutide) is administered s.c. once-weekly for 52 weeks in a dose escalating manner: 0.25 mg from week 1 to week 4, 0.5 mg from week 5 to week 8 and 1.0 mg from week 9 to week 52.
Registered arm groupsSemaglutide, Placebo (semaglutide)
Transition From Basal/Bolus to Once-weekly Subcutaneous Semaglutide and Basal Insulin in Patients With T2D
NCT04538352 · PHASE4 · COMPLETED · Type 2 Diabetes · 18 Years · 75 Years
Registered intervention descriptionSemaglutide: Medication for type 2 diabetes management
Registered arm groupsOnce-weekly sc semaglutide combined with once-daily insulin
16-week Flexible vs. 8-week Semaglutide Titration
NCT04447859 · PHASE3 · UNKNOWN · Diabetes type2 · 18 Years
Registered intervention descriptionSemaglutide: Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
Registered arm groupsSlow semaglutide titration
SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
NCT04287179 · PHASE3 · WITHDRAWN · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionSemaglutide: Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.
Registered arm groupsSemaglutide 0.25 mg, Semaglutide 0.50 mg
A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (C) Semaglutide Tablets
NCT04109508 · PHASE1 · COMPLETED · Healthy Volunteers, Type 2 Diabetes · 18 Years · 64 Years
Registered intervention descriptionOral semaglutide: Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks
Registered arm groupsSequence 1, Sequence 2, Sequence 3, Sequence 4, Sequence 5, Sequence 6
A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity
NCT04012255 · PHASE1 · TERMINATED · Overweight, Obesity · 18 Years · 65 Years
Registered intervention descriptionSemaglutide (administered by DV3396 pen): Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks
Semaglutide (administered by PDS290 pen): Increasing doses of semaglutide given sc in the stomach for 21 weeks
Registered arm groupsDV3396, PDS290
A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes
NCT03689374 · PHASE3 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionSemaglutide: Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.
Registered arm groupsSemaglutide
Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial
NCT03596450 · PHASE4 · COMPLETED · Diabetes Mellitus, Type 2 · 18 Years · 65 Years
Registered intervention descriptionSemaglutide: Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.
Standard of care: Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.
Registered arm groupsSemaglutide, Standard of care
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.
NCT02920385 · PHASE1 · COMPLETED · Diabetes, Healthy · 18 Years · 50 Years
Registered intervention descriptionSemaglutide: Oral administration once daily alone or together with levothyroxine or Placebo
SNAC: Oral administration once daily alone or together with levothyroxine or semaglutide
Levothyroxine: Oral administration alone or together with SNAC or oral semaglutide
Placebo: Oral administration once daily together with semaglutide
Registered arm groupsLevothyroxine/SNAC/Placebo/Semaglutide
Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
NCT02607865 · PHASE3 · COMPLETED · Diabetes, Diabetes Mellitus, Type 2 · 18 Years
Registered intervention descriptionsemaglutide: Oral administration once-daily
Registered arm groupsSemaglutide 14 mg, Semaglutide 3 mg, Semaglutide 7 mg
Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
NCT02172313 · PHASE1 · COMPLETED · Diabetes, Healthy · 18 Years · 75 Years
Registered intervention descriptionsemaglutide: For oral administration.
Registered arm groupsFasting conditions, Fed conditions, Reference dosing condition
Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo
NCT02079870 · PHASE1 · COMPLETED · Diabetes, Metabolism and Nutrition Disorder, Obesity · 18 Years
Registered intervention descriptionsemaglutide: Solution for subcutaneous (s.c. - under the skin) injection. 0.25 mg semaglutide once weekly for four weeks, 0.5 mg semaglutide once weekly for four weeks followed by 1.0 mg semaglutide once weekly for five weeks
Registered arm groupsSema
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects
NCT01619345 · PHASE1 · COMPLETED · Diabetes, Healthy · 18 Years · 64 Years
Registered intervention descriptionsemaglutide: Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.
Registered arm groupsPeriod 1: NN9924 with 50 mL water, Period 2: NN9924 with 240 mL water
TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD
NCT07487363 · PHASE1, PHASE2 · RECRUITING · Atherosclerotic Cardiovascular Diseases, Endothelial Dysfunction · 40 Years · 75 Years
Registered intervention descriptionTB-500: (thymosin beta 4 17-23 fragment
Registered arm groupsMatching placebo, TB-500 High Dose, TB-500 Low Dose, TB-500 Medium Dose
EGRIFTA WR — Dosage and Administration
BLA022505 · Theratechnologies Inc. · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA WR (tesamorelin) for injection 11.6 mg per vial formulation. For recommendations for tesamorelin for injection 2 mg per vial formulation, see the EGRIFTA SV prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. EGRIFTA WR and EGRIFTA SV are not substitutable. ( 2.1 ). The dose of EGRIFTA WR is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA WR into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Bacteriostatic Water for Injection, USP, to reconstitute EGRIFTA WR. (...
EGRIFTA SV — Dosage and Administration
BLA022505 · Theratechnologies Inc. · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. ( 2.1 ). The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA SV into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. ( 2.2 ) Reconstitute one vial of lyophilized powder with 0.5...
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
NCT07481734 · PHASE2 · RECRUITING · Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis · 18 Years · 75 Years
Registered intervention descriptionTesamorelin: for injection, 2 mg SC once daily; participant self-administration after training.
Dose may be reduced to 1 mg daily if IGF-1 z-score meets protocol threshold.
Registered arm groupsExperimental: Tesamorelin 2 mg subcutaneous once daily (with dose-reduction algorithm for elevated I, Placebo Comparator: Matching placebo subcutaneous once daily
Tesamorelin as an Adjunct to Exercise for Improving Physical Function in HIV
NCT06554717 · PHASE2 · RECRUITING · HIV-1-infection, Frailty, Impaired Physical Function · 50 Years · 80 Years
Registered intervention descriptionTesamorelin: Tesamorelin WR 1.28 mg given subcutaneously daily
Registered arm groupsTesamorelin Plus Exercise
Growth Hormone Releasing Hormone Analog to Improve Nonalcoholic Fatty Liver Disease and Associated Cardiovascular Risk
NCT03375788 · PHASE2 · COMPLETED · Non-Alcoholic Fatty Liver Disease, Obesity, Obesity, Abdominal · 18 Years · 65 Years
Registered intervention descriptionTesamorelin: Tesamorelin F4 formulation 1.4mg daily
Registered arm groupsTesamorelin
Body Composition and Adipose Tissue in HIV
NCT03226821 · PHASE4 · TERMINATED · HIV Lipodystrophy Syndrome, Growth Hormone Deficiency, Body Composition · 18 Years · 68 Years
Registered intervention descriptionTesamorelin: Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
Registered arm groupsTesamorelin
Tesamorelin to Improve Functional Outcomes After Peripheral Nerve Injury
NCT03150511 · PHASE2 · RECRUITING · Peripheral Nerve Injuries · 18 Years
Registered intervention descriptionTesamorelin 2 Milligrams (MG): Daily self-administered study drug
Registered arm groupsTesamorelin treatment
Impact of GHRH on Sleep Promotion and Endocrine Regulation in Service Members Who Sustained a Traumatic Brain Injury and Have Current Insomnia
NCT02931474 · PHASE2 · WITHDRAWN · Sleep Disorder, Traumatic Brain Injury · 18 Years · 45 Years
Registered intervention descriptionTesamorelin: Growth Hormone-Releasing
Registered arm groupsTesamorelin
Phase II Trial of Tesamorelin for Cognition in Aging HIV-Infected Persons
NCT02572323 · PHASE2 · COMPLETED · Mild Cognitive Impairment · 40 Years
Registered intervention descriptionTesamorelin: Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
Registered arm groupsDeferred group, Immediate group
Tesamorelin Effects on Liver Fat and Histology in HIV
NCT02196831 · NA · COMPLETED · Human Immunodeficiency Virus (HIV), Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) · 18 Years · 70 Years
Registered intervention descriptiontesamorelin
Placebo: inactive substance that looks like tesamorelin
Registered arm groupsTesamorelin, Placebo
Pharmacokinetic and Pharmacodynamic Study of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Positive Patients
NCT02012556 · PHASE1 · COMPLETED · HIV · 18 Years · 65 Years
Registered intervention descriptionTesamorelin
Registered arm groupsTesamorelin
Egrifta Replacement and Sleep Disordered Breathing
NCT01788462 · WITHDRAWN · Lipodystrophy · 18 Years · 75 Years
Registered intervention descriptionTesamorelin (Egrifta): We will observe the effects of Tesamorelin on patients with HIV and lipodystrophy.
Registered arm groupsHIV and Lipodystrophy
Abdominal Obesity, Cardiovascular Inflammation, and Effects of Growth Hormone Releasing Hormone Analogue
NCT01632592 · NA · WITHDRAWN · Abdominal Obesity · 18 Years · 55 Years
Registered intervention descriptionTesamorelin: The Growth Hormone Releasing Hormone analogue tesamorelin, 2mg subcutaneously daily by injection
Registered arm groupsGrowth Hormone Releasing Hormone
Diabetic Retinopathy in HIV Subjects Treated With EGRIFTA®
NCT01591902 · PHASE4 · TERMINATED · Diabetic Retinopathy, HIV · 18 Years
Registered intervention descriptionTesamorelin: Daily 2 mg subcutaneous injections of tesamorelin
Registered arm groupsEGRIFTA Treatment Grop
Long-term Observational Study in HIV Subjects Exposed to EGRIFTA®
NCT01579695 · TERMINATED · HIV · 18 Years
Registered intervention descriptionTesamorelin for injection: Daily 2 mg subcutaneous injections of Tesamorelin
Registered arm groupsExposed Group will receive Tesamorelin
Efficacy and Safety Study of Tesamorelin in Chronic Obstructive Pulmonary Disease (COPD) Subjects With Muscle Wasting
NCT01388920 · PHASE2 · TERMINATED · Chronic Obstructive Pulmonary Disease (COPD) · 40 Years · 75 Years
Registered intervention descriptionTesamorelin
Registered arm groupsTesamorelin 2 mg, Tesamorelin 3 mg
Effects of Growth Hormone Releasing Hormone in HIV
NCT01263717 · NA · COMPLETED · HIV, HIV Lipodystrophy · 18 Years · 65 Years
Registered intervention descriptiontesamorelin: Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
placebo: Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection
Registered arm groupsTesamorelin, Placebo (inactive injection)
Effect of Short Term Growth Hormone Releasing Hormone in Healthy Men
NCT00850564 · NA · COMPLETED · Healthy Volunteers · 18 Years · 60 Years
Registered intervention descriptionGrowth Hormone Releasing Hormone (Tesamorelin): Tesamorelin 2mg subcutaneous daily x 2 weeks
Registered arm groupsGrowth Hormone Releasing Hormone
Effects of Short-term Growth Hormone in HIV-infected Patients
NCT00795210 · NA · COMPLETED · HIV Lipodystrophy · 18 Years · 60 Years
Registered intervention descriptionGrowth Hormone Releasing Hormone: Tesamorelin (GHRH) 2mg SC QD x 2 weeks
Registered arm groupsGrowth Hormone Releasing Hormone
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy
NCT00608023 · PHASE3 · COMPLETED · Lipodystrophy, HIV Infections · 18 Years · 65 Years
Registered intervention descriptionTesamorelin
Placebo for Tesamorelin
Registered arm groupsPlacebo-Tesamorelin (P-T), Tesamorelin 12 months (T-T), Tesamorelin-Placebo (T-P)
Thymosin Alpha-1 for irAE Secondary to ICIs
NCT06178146 · PHASE4 · UNKNOWN · IrAE · 18 Years · 75 Years
Registered intervention descriptionThymosin Alpha1: Based on the conventional treatment, subcutaneous injection of Tα-1 (1.6 mg, qd) in Week 1; and in Week 2, subcutaneous injection of thymalfasin 1.6 mg, 3 times a week, followed by twice a week for 1 month since Week 3.
Immunosuppressant: Grade 2 irAEs: corticosteroid alone Grade 3 and above irAEs: corticosteroids combined with other immunosuppressants Steroid-refractory irAE: After 48-72 hours of systemic steroid therapy, the symptoms do not improve or worsen, and the second-line immunosuppressant therapy is adopted.
Registered arm groupsTα-1 group, Control group
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
NCT07644897 · PHASE2 · RECRUITING · Melanoma, Immune-related Adverse Event, Immune Checkpoint Inhibitor · 60 Years
Registered intervention descriptionThymosin Alpha 1 and Anti-PD-1 monoclonal antibody: Thymosin Alpha 1 1.6mg, sc,QD,d1-7;1.6mg, sc,three times per week, d8-21 Anti-PD-1 monoclonal antibody (Toripalimab) 240mg per dose,ivdrip,Q3W
Registered arm groupsintervention group
The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC
NCT06139419 · PHASE2 · COMPLETED · Non-small Cell Lung Cancer · 18 Years
Registered intervention descriptioninduction chemo-immunotherapy: All participants receive two cycles of albumin-bound paclitaxel (260mg/m2) on d1 and cisplatin (25mg/m2) from d1 to d3 in combination with tislelizumab (200mg) on d1. concurrent chemotherapy: Concurrent chemotherapy consists of weekly albumin-bound paclitaxel (50mg/m2) and cisplatin (25mg/m2). Immunotheapy consolidation: Participants without disease progression, grade ≥3 toxicities, and/or grade ≥2 pneumonitis after CCRT receive tislelizumab 200 mg (Q3W) for up to 12 months. Thymosin Alpha1: Participants in the Tα1 treatment group will receive Tα1 from the beginning of induction chemo-immunotherapy until the completion of immunotherapy consolidation. In detail, Tα-1 would be administered according to the following three stages: 1. Induction chemo-immunotherapy: Tα-1 will be subcutaneously administered at 4.8 mg on d1 and d3 for each cycle. 2. Concurrent chemoradiotherapy: Tα-1 will be subcutaneously...
Registered arm groupsConcurrent Tα-1 group, Control group
A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma
NCT00082082 · PHASE2 · COMPLETED · Carcinoma, Hepatocellular · 18 Years
Registered intervention descriptionThymalfasin (thymosin alpha-1)
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
NCT07817875 · PHASE3 · NOT_YET_RECRUITING · Obesity · 6 Years · 11 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groupsTirzepatide
Zepbound — Dosage and Administration
NDA217806 · Eli Lilly and Company · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION Recommended Dose Escalation Schedule The recommended starting dosage is 2.5 mg injected subcutaneously once weekly for 4 weeks. Increase the dosage in 2.5 mg increments after at least 4 weeks until recommended maintenance dosage is achieved. ( 2.1 ) Consider treatment response and tolerability when selecting the maintenance dosage. ( 2.1 ) Recommended Maintenance and Maximum Dosage Weight Reduction and Long-Term Maintenance: 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly. ( 2.2 ) Obstructive Sleep Apnea: 10 mg or 15 mg injected subcutaneously once weekly. ( 2.2 ) Maximum Recommended Dosage: 15 mg injected subcutaneously once weekly. ( 2.2 ) Administration Instructions Refer to the Full Prescribing Information for additional important administration instructions about ZEPBOUND presentations. ( 2.4...
Mounjaro — Dosage and Administration
NDA215866 · Eli Lilly and Company · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or have another person inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to the Full Prescribing Information for additional important administration instructions about MOUNJARO presentations. ( 2.2...
Tirzepatide for Ileal Pouch-anal Anastomosis (IPAA) and Chronic High Bowel Frequency (I8F-NS-X008)
NCT07756359 · PHASE4 · NOT_YET_RECRUITING · Pouch, Ileal, Pouches, Ileoanal, Bowel Diseases, Inflammatory · 18 Years · 80 Years
Registered intervention descriptionTirzepatide: Tirzepatide will be administered subcutaneously
Registered arm groupsOptimized Standard of Care anti-diarrheal therapy, Tirzepatide
MOUNJARO — Dosage and Administration
NDA215866 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to...
MOUNJARO — Dosage and Administration
NDA215866 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to...
MOUNJARO — Dosage and Administration
NDA215866 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to...
MOUNJARO — Dosage and Administration
NDA215866 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to...
MOUNJARO — Dosage and Administration
NDA215866 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to...
MOUNJARO — Dosage and Administration
NDA215866 · A-S Medication Solutions · SUBCUTANEOUS
Source-supplied dosage section2 DOSAGE AND ADMINISTRATION The recommended starting dosage is 2.5 mg injected subcutaneously once weekly. ( 2.1 ) After 4 weeks, increase to 5 mg injected subcutaneously once weekly. ( 2.1 ) If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose. ( 2.1 ) Maximum dosage ( 2.1 ): Adults: 15 mg subcutaneously once weekly. Pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly. Administer once weekly at any time of day, with or without meals. ( 2.2 ) Inject subcutaneously in the abdomen, thigh, or another person should inject in the back of the upper arm. Rotate injection sites with each dose. ( 2.2 ) Refer to...
Tirzepatide for Treatment of CCCA
NCT07734870 · PHASE2 · RECRUITING · Central Centrifugal Cicatricial Alopecia (CCCA) · 18 Years · 80 Years
Registered intervention descriptionTirzepatide: Tirzepatide solution will be self-administered by subcutaneous injection once weekly. Participants will receive 2.5 mg once weekly for the first 4 weeks, followed by 5 mg once weekly for the remainder of the 12-month treatment period. Injection sites will be rotated among the abdomen, thigh, or upper arm.
Registered arm groupsTirzepatide Treatment
Effects of GLP-1 RAs on Human Lactation Outcomes
NCT07720414 · RECRUITING · Lactation, Weight Loss
Registered intervention descriptionInjected GLP-1 Receptor Agonists and Dual Agonists: Participants are prescribed this medication by their care provider(s) as part of their postnatal clinical care, including but not limited to semaglutide and tirzepatide. The investigators do not provide, manage, or assign the medication.
Registered arm groupsBreastfeeding mothers prescribed GLP-1 RA therapies
Non-Invasive Hepatic and Metabolic Index Changes After Incretin Therapy in Overweight/Obesity
NCT07701005 · COMPLETED · Steatosis of Liver, Metabolic Liver Injury, Obesity · 18 Years · 75 Years
Registered intervention descriptionTirzepatide: Once-weekly subcutaneous dual GIP/GLP-1 receptor agonist administered for at least 12 weeks; dose individualized and titrated at the treating physician's discretion according to routine clinical practice and patient tolerability.
Registered arm groupsTirzepatide
High-protein plUs reSistance Training in gLucagon-like pEptide 1 Receptor Agonist Users (HUSTLE)
NCT07700030 · NA · NOT_YET_RECRUITING · Weight Loss · 30 Years · 60 Years
Registered intervention descriptionHigh protein diet: The standardized highprotein diet counseling focuses on achieving 2.5 g/kg FFM/day of dietary protein through food and commercially available protein powder supplements that will be provided to participants.
Registered arm groupsHigh Protein (HP), High Protein (HP) Resistance Training (RT)
GLP-1 Receptor Agonists and Alzheimer's Disease: A Multi-National Target Trial Emulation
NCT07677865 · COMPLETED · Alzheimer Disease, Diabetes Mellitus Type 2, Obesity & Overweight · 40 Years
Registered intervention descriptionGLP-1 Receptor Agonists: like semaglutide、tirzepatide、liraglutide,etc.
Registered arm groupsGLP-1 Receptor Agonist (GLP-1RA) Initiators
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Effect of LAE102 Injection in Combination With Tirzepatide on Body in Obese Participants
NCT07671391 · PHASE2 · NOT_YET_RECRUITING · Obesity Adult Onset · 18 Years · 75 Years
Registered intervention descriptionLAE102 +Tirzepatide: Receive LAE102, once a week, by subcutaneous injection.The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased every 4 weeks.
LAE102 placebo,+Tirzepatide: Receive the LAE102 placebo, once a week, by subcutaneous injection. The dosage of Tirzepatide starts at lower dose, administered subcutaneously once a week, and is gradually increased to a higher dose level every 4 weeks.
Registered arm groupsTreatment group, Placebo group
Tirzepatide on Atrial Fibrillation Recurrence After Catheter Ablation in Patients With Obesity and HFpEF
NCT07630454 · PHASE4 · NOT_YET_RECRUITING · Atrial Fibrillation, Heart Failure With Preserved Ejection Fraction (HFpEF), Tirzepatide · 18 Years · 80 Years
Registered intervention descriptionTirzepatide: Dual GIP and GLP-1 receptor agonist administered as a weekly subcutaneous injection.
Titrated from 2.5 mg/week to a target of 10 mg/week (maximum 15 mg/week) over 12 weeks, then maintained at the maximum tolerated dose for the remainder of the 12-month treatment period.
Registered arm groupsTirzepatide + Lifestyle Intervention
Tirzepatide in the Treatment of Endometrial Cancer
NCT07605247 · PHASE2 · NOT_YET_RECRUITING · Endometrial Cancer · 18 Years · 99 Years
Registered intervention descriptionTirzepatide: Phase I (Months 0-3): All participants receive LNG-IUD alone
LNG-IUD plus tirzepatide: Phase II (Months 3-9): All participants continue LNG-IUD plus tirzepatide (titrated to maximally tolerated dose).
Registered arm groupsLNG-IUD + Tirzepatide
GLP-1 Therapy After Bariatric Surgery in Chinese Patients With Obesity
NCT07633639 · NA · RECRUITING · Obesity · 18 Years · 60 Years
Registered intervention descriptionLSG-Tirzepatide group: 1. Basic Treatment Measures Within 0-30 days after sleeve gastrectomy, all patients received very low-calorie enteral nutrition powder (100 kcal/day). From 30 to 90 days post-surgery, a low-energy diet (400 kcal/day) was provided. Beyond 90 days post-surgery, a calorie-restricted diet was implemented (1,500 kcal/day for men and 1,200 kcal/day for women). 2. In addition to laparoscopic sleeve gastrectomy and postoperative basic nutritional counseling,the LSG-Tirzepatide group received subcutaneous Tirzepatide injections from 1 to 6 months postoperatively.The specific protocol was as follows:In the intervention group, Tirzepatide treatment was initiated at 1 month after LSG. The starting dose was 2.5 mg per week and was subsequently titrated up based on individual patient response to a maximum maintenance dose of 10 mg per week. The treatment continued...
Registered arm groupsLSG-Tirzepatide group
Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists
NCT07619989 · NA · RECRUITING · Obesity & Overweight · 18 Years · 50 Years
Registered intervention descriptiontranscutaneous auricular vagus nerve stimulation: Participants will receive active transcutaneous auricular vagus nerve stimulation plus tirzepatide 5 mg for 12 weeks. Active stimulation will be delivered to the bilateral cymba conchae, an auricular region innervated by the auricular branch of the vagus nerve. Stimulation will use an intermittent waveform of 15 seconds on and 5 seconds off at 20 Hz, with a pulse width of 0.2 ms. Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks. Tirzepatide will be administered as a subcutaneous injection once weekly. Sham: Participants will receive sham stimulation in addition to...
Registered arm groupstaVNS Plus Tirzepatide 5 mg, Sham Stimulation Plus Tirzepatide 5 mg
Multi-Site Trial of Tirzepatide for Smoking Cessation
NCT07602699 · PHASE2 · RECRUITING · Smoking Cessation, Smoking Behaviors · 21 Years · 65 Years
Registered intervention descriptionTirzepatide: Participants will receive tirzepatide (subcutaneous injection) at doses of 2.5mg for Weeks 1-4, 5mg for Weeks 5-8, 7.5mg for Weeks 9-12, and 10mg for Weeks 13-16
Registered arm groupsTirzepatide
Comparative Observation of Metabolic and Pharmacologic Adipose Remodeling With Enhanced Incretin AgonisTs
NCT07589322 · NA · RECRUITING · Obesity and Metabolic Syndrome · 20 Years · 65 Years
Registered intervention descriptionTirzepatide with lifestyle modification: Starting at Tirzepatide 2.5 mg weekly and escalated as tolerated to 10 mg along with standardized lifestyle counseling by a dietitian (caloric deficit, physical activity guidance) and written materials.
Registered arm groupsTirzepatide arm
Tirzepatide Following Adrenalectomy in Mild Autonomous Cortisol Secretion
NCT07573163 · PHASE2 · RECRUITING · Mild Autonomous Cortisol Secretion (MACS), Adrenalectomy; Status · 18 Years
Registered intervention descriptionTirzepatide: Tirzepatide will be initiated at the lowest dose of 2.5 mg once weekly for 4 weeks. The dose will then be titrated every 4 weeks based on patient tolerance to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg.
Registered arm groupsGLP-1 Treatment
Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)
NCT07559500 · PHASE1 · RECRUITING · Alcohol Use Disorder (AUD) · 21 Years · 65 Years
Registered intervention descriptionTirzepatide: Drug approved for diabetes administered SQ. Subject is blind to drug.
Registered arm groupsTirzepatide - Part 2, [11C]NNC-112 - Part 2, [11C]raclopride plus drug - Part 2
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
NCT07527910 · PHASE2 · RECRUITING · Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) · 18 Years · 75 Years
Registered intervention descriptionTirzepatide: Administered per the protocol
Registered arm groupsPart A: A1, Part A: A2, Part B: B1, Part B: B2
Tirzepatide to Reduce rEcurrence And Burden After Ablation of Atrial Fibrillation
NCT07382024 · NA · NOT_YET_RECRUITING · Atrial Fibrillation Ablation, Persistent Atrial Fibrillation, Obesity & Overweight · 18 Years · 80 Years
Registered intervention descriptionTirzepatide: Subcutaneous tirzepatide 2.5 mg once weekly, initiated approximately 4 weeks before the scheduled de novo catheter ablation and continued for 3 months after the procedure (total treatment duration about 4 months), in addition to standard peri-procedural and post-ablation care.
Standard Care (in control arm): Standard peri-procedural and post-ablation care for persistent atrial fibrillation without tirzepatide or other study-specific metabolic pharmacotherapy.
Registered arm groupsTirzepatide + Standard Care(Intervention: Drug - tirzepatide), Standard Care(Intervention: Other - standard care / no tirzepatide)
Clinical and Neurobehavioral Changes With Weight Loss Drug Discontinuation and Reinitiation
NCT07387796 · NA · RECRUITING · Drug Discontinuation, Substance Use Disorders, Eating Behavior Changes · 18 Years · 70 Years
Registered intervention descriptionDiscontinuation and Reinitiation of Tirzepatide: Participants will temporarily pause their tirzepatide medication for 3-4 weeks and then restart it for 6-8 weeks under the supervision of a study physician. The medication change is done only for research purposes to study how stopping and restarting tirzepatide affects brain activity, appetite, mood, and other health measures. During this period, participants will complete MRI scans, behavioral assessments, questionnaires, and provide stool samples across three study visits.
Registered arm groupsTirzepatide Discontinuation and Re-Initiation Arm
Resistance Exercise and Incretin Mimetic for Cardiometabolic Health in Survivors of ALL With Obesity
NCT07228741 · PHASE2 · RECRUITING · Acute Lymphoblastic Leukemia, Obesity · 18 Years
Registered intervention descriptionTirzepatide: A once-weekly subcutaneous injection starting at 2.5 mg and dose escalation every 4 weeks up to a maximum of 15 mg, following FDA-approved guidelines. Dose escalation may be paused for exceptional responders.
Registered arm groupsAdult survivors of childhood acute lymphoblastic leukemia (ALL)
Tirzepatide to Slow Biological Aging
NCT07220473 · PHASE2 · RECRUITING · Aging, LONGEVITY 1 · 55 Years · 70 Years
Registered intervention descriptionZepbound: Auto injectors with a 2.5 mg dosage are given subcutaneously weekly.
Registered arm groupsTirzepatide
Tirzepatide in Obesity-Driven Endometrial Cancer
NCT07065552 · EARLY_PHASE1 · RECRUITING · Endometrial Cancer, Obesity · 18 Years
Registered intervention descriptionTirzepatide: Tirzepatide will be administered once weekly, subcutaneously, and patients will be taught how to administer this drug at home. Patients will be started on a dose of 5 mg tirzepatide weekly for four weeks prior to surgical staging. .
Registered arm groupsendometrial carcinoma
Tolerance and Pharmacokinetic/Pharmacokinetic Study of IBI362 15mg in Patients With Moderate to Severe Obesity
NCT07000955 · PHASE1, PHASE2 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years · 55 Years
Registered intervention descriptionTirzepatide: Tirzepatide administered subcutaneously (SC) once a week.
Registered arm groupsTirzepatide
A Long-Term Study of Tirzepatide (LY3298176) in Adults With Type 1 Diabetes and Obesity or Overweight
NCT06962280 · PHASE3 · ACTIVE_NOT_RECRUITING · Type 1 Diabetes, Obesity, Overweight · 18 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groupsTirzepatide
A Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of RO7204239 in Combination With Tirzepatide in Participants With Obesity or Overweight With At Least One Weight-related Comorbidity
NCT06965413 · PHASE2 · ACTIVE_NOT_RECRUITING · Obesity, Overweight, Overweight With One Weight Related Comorbidity · 18 Years
Registered intervention descriptionTirzepatide: Tirzepatide will be administered as per the schedule specified in the arms.
Registered arm groupsPlacebo + Tirzepatide, RO7204239 high dose + Tirzepatide, RO7204239 low dose + Tirzepatide, RO7204239 medium dose + Tirzepatide
A First-In-Human Study of ARO-ALK7 in Adults With Obesity With and Without Type 2 Diabetes Mellitus
NCT06937203 · PHASE1, PHASE2 · RECRUITING · Obesity, Diabetes Mellitus, Type 2 · 18 Years · 65 Years
Registered intervention descriptionARO-ALK7: Subcutaneous (SC) injection
Placebo: calculated volume to match active treatment by SC injection
Registered arm groupsPart 1 and Part 2 (optional cohort): ARO-ALK7, Part:2: ARO-ALK7 + Tirzepatide, Part 1 and Part 2 (optional cohort): Placebo, Part 2: Placebo + Tirzepatide
A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide
NCT06897475 · PHASE2 · RECRUITING · Type 2 Diabetes · 18 Years · 75 Years
Registered intervention descriptionLY3457263: Administered SC
Placebo: Administered SC
Registered arm groupsLY3457263 Dose 1, LY3457263 Dose 2, LY3457263 Dose 3, Placebo
Effect of Tirzepatide on Brown Adipose Tissue in Obesity
NCT06893211 · PHASE2 · COMPLETED · Obesity · 20 Years · 50 Years
Registered intervention descriptionTirzepatide: Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It will be administered via subcutaneous injection once weekly in a dose-titration scheme: starting at 2.5 mg, and increased every 4 weeks by 2.5 mg up to a maximum of 15 mg, based on tolerability. The medication will be supplied in prefilled pens identical in appearance to placebo pens.
Placebo: Placebo will be administered via subcutaneous injection once weekly using pens that are visually indistinguishable from those used for tirzepatide. Dose escalation will follow the same schedule (2.5 mg-equivalent increments every 4 weeks) to preserve blinding integrity.
Registered arm groupsTirzepatide, Placebo
Effects of Long-Acting GLP-1 (Glucagon-like Peptide-1) or Dual Incretin (GLP-1 and GIP [Glucose-dependent Insulinotropic Peptide]) Modulation on Gastric Motor Functions
NCT06801015 · PHASE4 · ACTIVE_NOT_RECRUITING · Obesity · 18 Years · 75 Years
Registered intervention descriptionTirzepatide: Both interventions are approved by FDA for the treatment of obesity and are administered by subcutaneous injection once per week
Registered arm groupsTirzepatide
Study of Tirzepatide for Recovery and Alcohol Use Management
NCT06727331 · PHASE2 · RECRUITING · Alcohol Use Disorder (AUD) · 18 Years
Registered intervention descriptionTirzepatide: This intervention will consist of the FDA-approved dosing schedule. Participants will receive 2.5mg weekly injections for 4 weeks. IDS will extract tirzepatide and draw the doses into syringes.
Registered arm groupsTirzepatide
Normal-weight Diabetes: Adipocyte-directed Therapy With Pioglitazone or Tirzepatide
NCT06657209 · PHASE4 · RECRUITING · Diabetes Mellitus, Type 2, Diabetes, Type 2 Diabetes · 30 Years · 70 Years
Registered intervention descriptionTirzepatide: 16 weeks started at 2.5mg/week and increased to 5mg/week dose
Registered arm groupsNormal weight with diabetes pioglitazone first, tirzepatide second, Normal weight with diabetes tirzepatide first pioglitazone second
Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants
NCT06648031 · PHASE1 · COMPLETED · Type2diabetes · 18 Years · 65 Years
Registered intervention descriptionArm 5- Tirzepatide: Tirzepatide arm - 20mg for 4 weeks and then 40mg for 8 weeks
Registered arm groupsArm 5- DehydraTECH Tirzepatide
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
NCT06640972 · PHASE2 · COMPLETED · Triglycerides, Weight Gain Trajectory, Cholesterol, Elevated · 18 Years · 65 Years
Registered intervention descriptionRDX-002: Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
Placebo: Matching placebo
Registered arm groupsInvestigational drug, Placebo
A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)
NCT06605703 · PHASE4 · COMPLETED · Obesity, Overweight · 18 Years
Registered intervention descriptionBupropion-Naltrexone: Bupropion-Naltrexone
Bupropion-Naltrexone-Metformin: Bupropion-Naltrexone-Metformin
Registered arm groupsWW Clinic + Meds v1, WW Clinic + Meds v2
Ixekizumab Concomitantly Administered With Tirzepatide in Adults With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight
NCT06588283 · PHASE3 · COMPLETED · Psoriasis, Obesity · 18 Years
Registered intervention descriptionTirzepatide: Administered SC.
Registered arm groupsIxekizumab and Tirzepatide
Tirzepatide Weight Loss for MRD+ Early Breast Cancer
NCT06517212 · PHASE2 · RECRUITING · Breast Cancer, Breast Neoplasms, Breast Cancers · 18 Years
Registered intervention descriptionTirzepatide: Patients will receive tirzepatide once weekly for up to 2 years.
Registered arm groupstirzepatide
Study That Tests AD109 in Patients Taking GLP-1 Drugs
NCT06400615 · PHASE2 · COMPLETED · OSA · 18 Years · 75 Years
Registered intervention descriptionAD109: Oral administration at bedtime
Registered arm groupsArm 1, Arm 2
A Research Study Comparing How Well Different Doses of the Medicine NN0519-0130 Help People With Excess Body Weight Lose Weight
NCT06326060 · PHASE2 · COMPLETED · Obesity · 18 Years · 75 Years
Registered intervention descriptionTirzepatide: Tirzepatide will be administered subcutaneously.
Registered arm groupsDosing scheme g: Tirzepatide
Evaluate the Efficacy of TIRZEPATIDE for the Treatment of Moderate to Severe HS Hidradenitis Suppurativa
NCT06301256 · NA · UNKNOWN · Hidradenitis Suppurativa · 18 Years
Registered intervention descriptionTIRZEPATIDE: Tirzepatide injection contains tirzepatide, a once weekly dual receptor, GIP and GLP-1 receptor agonis t. It is a 39-amino-acid modified peptide with a C20 fatty diacid moiety that enables albumin binding and prolongs the half-life. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68.
GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Pilot Trial
NCT06162715 · PHASE2, PHASE3 · ACTIVE_NOT_RECRUITING · Severe Obesity, Obesity, BMI Greater Than 30 · 25 Years · 65 Years
Registered intervention descriptionTirzepatide: Tirzepatide will be initiated 12 or 18 months (12 months + 24 weeks) after patients undergo Roux-en-Y Gastric Bypass. Patients will be started on the lowest dose of 2.5 mg and the dose increased every 6 weeks following an adaptive maximum dose titration protocol. Patients will then complete a final 4 weeks of the study drug.
Registered arm groupsTirzepatide Group
Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Low-grade Cancer of the Endometrium
NCT06073184 · PHASE2 · NOT_YET_RECRUITING · Endometrial Cancer, Atypical Hyperplasia · 18 Years · 41 Years
Registered intervention descriptionMounjaro: Weekly subcutaneous injection of 2.5mg tirzepatide at baseline with dose escalation by 2.5mg every 4 weeks to reach 15mg or the maximum tolerated dose, by Week 20
Registered arm groupsTirzepatide and Progestin Intrauterine Device
Effects of Tirzepatide Plus Intensive Lifestyle Therapy on Body Weight and Metabolic Health in Latinos With Obesity
NCT06009653 · PHASE4 · WITHDRAWN · Obesity, Metabolic Disease · 21 Years · 65 Years
Registered intervention descriptionTirzepatide: Participants will receive subcutaneous injections of tirzepatide that gradually increase up to 15 mg per week.
Registered arm groupsIntensive lifestyle intervention plus tirzepatide
Gastric Sleeve-Induced Weight Loss on Shortness of Breath in Obesity
NCT05812183 · PHASE4 · WITHDRAWN · Dyspnea, Quality of Life · 18 Years
Registered intervention descriptionMedical weight loss: The medical weight loss intervention will follow UCLA's RFO standard protocol. Over a period of 12 months, patients in the medical weight loss group will follow a very low caloric diet (VLCD) at the UCLA RFO program. All study patients will be prescribed a VLCD, an exercise regimen and will participate in group classes on behavioral modification. The caloric intake consists of a commercially prepared meal replacement powder supplying 700-800 cal/day. Each formula packet provides 100kcal and 15g of high biological value protein, and the daily allowance of required minerals and vitamins. Some patients may recieve adjuvant drug therapy including Orlistat (Xenical, Alli), Phentermine-topiramate (Qsymia), Naltrexone-bupropion (Contrave), Liraglutide (Saxenda), Semaglutide (Wegovy), Tirzepatide (Zepbound) or Setmelanotide (Imcivree).
Registered arm groupsMedical weight loss
A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices
NCT05810597 · PHASE1 · COMPLETED · Healthy · 18 Years · 70 Years
Registered intervention descriptionTirzepatide: Administered SC
Single Dose Pen: Used to administer tirzepatide SC
Multi-use Prefilled Pen: Used to administer tirzepatide SC
Registered arm groupsSequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP), Sequence 2: Tirzepatide by MUPFP / SDP
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
NCT05412004 · PHASE3 · COMPLETED · Obstructive Sleep Apnea, Obesity · 18 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groupsTirzepatide MTD_GPI1, Tirzepatide MTD_GPI2
A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
NCT04844918 · PHASE3 · COMPLETED · Obesity · 20 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groups10 Milligrams (mg) Tirzepatide, 15 mg Tirzepatide
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin
NCT04537923 · PHASE3 · COMPLETED · Type 2 Diabetes · 18 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groups10 mg Tirzepatide, 15 mg Tirzepatide, 5 mg Tirzepatide
A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants
NCT04004988 · PHASE1 · COMPLETED · Healthy · 21 Years · 70 Years
Registered intervention descriptionTirzepatide: Administered SC
Prefilled syringe (PFS): PFS used to administer tirzepatide
Auto-injector (AI): AI used to administer tirzepatide
Registered arm groupsTirzepatide Reference, Tirzepatide Test
A Study of Tirzepatide in Participants With Impaired Liver Function
NCT03940742 · PHASE1 · COMPLETED · Hepatic Insufficiency · 18 Years · 85 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groupsMild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function, Severe Hepatic Impairment
A Long-term Safety Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes
NCT03861039 · PHASE3 · COMPLETED · Type 2 Diabetes Mellitus · 20 Years
Registered intervention descriptionTirzepatide: Administered SC
Registered arm groups10 mg Tirzepatide, 15 mg Tirzepatide, 5 mg Tirzepatide
A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function
NCT03482024 · PHASE1 · COMPLETED · Renal Insufficiency, End Stage Renal Disease · 18 Years · 85 Years
Registered intervention descriptionTirzepatide: Administered SC.
Registered arm groupsTirzepatide - Control, Tirzepatide - End Stage Renal Disease (ESRD), Tirzepatide - Mild Renal Impairment, Tirzepatide - Moderate Renal Impairment, Tirzepatide - Severe Renal Impairment
A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus
NCT03131687 · PHASE2 · COMPLETED · Type 2 Diabetes Mellitus · 18 Years · 75 Years
Registered intervention descriptiontirzepatide: Administered SC
Registered arm groups1 mg Tirzepatide, 10 mg Tirzepatide, 15 mg Tirzepatide, 5 mg Tirzepatide
Registered study designVIP Aviptadil for Severely Ill Inpatients With COVID-19 (An ACTIV-3b/TESICO Treatment Trial)
NCT06729606 · PHASE3 · COMPLETED · Covid19 · 18 Years
Registered intervention descriptionAviptadil: Administered by IV infusion over 12 hours per day for 3 days. The Day 1 infusion rate is 50 pmol/kg/hr, the Day 2 infusion rate is 100 pmol/kg/hr, and the Day 3 infusion rate is 150 pmol/kg/hr.
Aviptadil Placebo: Commercially available 0.9% sodium chloride solution. Administered by IV infusion over 12 hours per day for 3 days.
Registered arm groupsAviptadil + SOC, Placebo + SOC
Registered study designVIP Vestibular Innovation in Pain
NCT06559839 · NA · COMPLETED · Pain, Fatigue, Quality of Life · 18 Years · 99 Years
Registered intervention descriptionVestibulocortical Stimulation: 50cc of cold water (4℃) irrigated to the right external ear canal, at 1-2 cc/second, with the patient laying supine.
Registered arm groupsFibromyalgia, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Long Covid, Post Treatment Lyme Disease Syndrome
Joette Calabrese Survivalist Kit — Dosage and Administration
OHM PHARMA INC. · ORAL
Source-supplied dosage sectionDIRECTIONS: Adults and children above 12 years: dissolve 3-5 pellets under the tongue or dilute in approximately 1 oz of purified water and sip as directed by a health care professional.
Registered study designVIP Inhaled ZYESAMI (Aviptadil Acetate) for Treatment of Severe COVID-19
NCT05137795 · PHASE3 · WITHDRAWN · SARS-CoV 2, COVID, ARDS · 18 Years · 85 Years
Registered intervention descriptionZYESAMI™ (aviptadil acetate): Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer
Registered arm groupsSevere COVID-19 ZYESAMI™
Registered study designVIP A Clinical Study Evaluating Inhaled Aviptadil on COVID-19
NCT04844580 · PHASE2 · COMPLETED · Covid19 · 18 Years · 70 Years
Registered intervention descriptionInhaled Aviptadil: Aviptadil is the synthetic analogue of the Vasoactive Intestinal Peptide (VIP), a biologically active 28 amino acid natural peptide that is endogenously synthesized in humans. It is one of the signaling molecules of the neuroendocrine immune network and has vasodilator, anti-proliferative, anti-inflammatory and immunomodulatory properties.
Placebo: Aviptadil Placebo will be used for this arm.
Registered arm groupsStandard Treatment + Inhaled Aviptadil, Standard Treatment + Placebo
Registered study designVIP Self-Management Across the Care Continuum
NCT04540679 · NA · UNKNOWN · Spinal Cord Injuries · 18 Years
Registered intervention descriptionVIP4SCI: Technology-enabled self-management \& rehabilitation solution
Registered arm groupsInpatient - Platform Access, Inpatient - Standard Care Delayed Platform, Outpatient - Platform Access
Registered study designVIP Pemziviptadil (PB1046), a Long-acting, Sustained Release Human VIP Analogue, Intended to Provide Clinical Improvement to Hospitalized COVID-19 Patients at High Risk for Rapid Clinical Deterioration and Acute Respiratory Distress Syndrome (ARDS).
NCT04433546 · PHASE2 · TERMINATED · Acute Respiratory Distress Syndrome, Coronavirus, Hypoxic Respiratory Failure · 18 Years · 85 Years
Registered intervention descriptionPemziviptadil (PB1046): Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Low Dose (10 mg) Control: Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)
Registered arm groupsHigh Dose (100 mg) Group, Middle Dose (40 mg) Group, Low Dose (10 mg) Control Group
Registered study designVIP The Value of PET Quantitative Analysis of Coronary Physiology in Coronary Microvascular Disease
NCT04005963 · UNKNOWN · PET / CT, Coronary Microvascular Disease · 20 Years · 80 Years
Registered intervention description13N-NH3 PET cardiac blood flow perfusion rest and load imaging: Immediately after the bedside injection of 13N-NH3 370 MBq, dynamic 2D collection of heart images 10 min, scanning 1 bed; , a total of 6 min), 3min bedside injection 13N?NH3 370-540 MBq immediately after the dynamic 2D collection of heart image 10 min. Both rest and load imaging are corrected for CT attenuation.
Image reconstruction is carried out by the method of maximum expectation of an ordered subset, the dynamic image is divided into the early phase of the first 2 min and the late phase of the last 8 min, the captured image is replayed (VIP replay) of the volume image protocol and the gated data is reconstructed.
Registered study designVIP Phase 2 Study to Assess Safety, Tolerability and Efficacy of Once Weekly SC Pemziviptadil (PB1046) in Subjects With Symptomatic PAH
NCT03556020 · PHASE2 · TERMINATED · Pulmonary Arterial Hypertension · 18 Years · 79 Years
Registered intervention descriptionPemziviptadil (PB1046): Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
Registered arm groupsHigh Dose Group, Low Dose Group
Registered study designVIP Choice Architecture and Colorectal Cancer Screening Outreach
NCT03246438 · NA · COMPLETED · Cancer of Colon · 50 Years · 74 Years
Registered intervention descriptionColonoscopy only: Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy. Colonoscopy outreach + mailed FIT follow-up: Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit. Colonoscopy + Mailed FIT outreach and follow-up: Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a...
Registered arm groupsControl, Sequential Choice, Active Choice
Registered study designVIP Video Information Provider for HIV-Associated Non-AIDS (VIP-HANA) Symptoms
NCT03182738 · NA · COMPLETED · HIV (Human Immunodeficiency Virus), AIDS (Acquired Immunodeficiency Syndrome) · 18 Years
Registered intervention descriptionVIP app without HIV-related symptom strategies.: The control group will receive the VIP app without HIV-related symptom strategies
VIP app that delivers HIV-related symptom strategies.: The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
Registered arm groupsControl, Intervention
Registered study designVIP Virtual Interactive Platform (VIP) Transplant Research Study
NCT02828605 · EARLY_PHASE1 · COMPLETED · Transplant Patients · 10 Years · 80 Years
Registered intervention descriptionVirtual Interactive Platform (VIP) Transplant
Registered arm groupsExperimental Group
Registered study designVIP Vascular Inflammation in Psoriasis-Ustekinumab (VIP-U)
NCT02187172 · PHASE4 · COMPLETED · Psoriasis, Cardiovascular Disease · 18 Years
Registered intervention descriptionUstekinumab
Placebo
Registered arm groupsPlacebo, Ustekinumab (Stelara)
Registered study designVIP Comparison of Treximet & Imitrex as They Affect the Levels of Inflammatory Markers When the Patient is Actively Having a Migraine Headache
NCT01916395 · COMPLETED · Migraine · 18 Years · 65 Years
Registered intervention descriptionsumatriptan and Treximet: sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.
Registered arm groupsImitrex and Treximet
Registered study designVIP Vascular Inflammation in Psoriasis Trial (The VIP Trial)
NCT01553058 · PHASE4 · COMPLETED · Psoriasis, Cardiovascular Disease · 18 Years
Registered intervention descriptionAdalimumab (Humira): Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
Placebo Injection: Placebo injection will be given according to the same dose and schedule as the active comparator.
NB-UVB phototherapy: Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
Registered arm groupsAdalimumab (Humira), Placebo Injection, NB-UVB phototherapy
Registered study designVIP Extending Contingency Management's Benefits With Progressively Increasing Variable Interval Prize Reinforcement
NCT01184040 · NA · COMPLETED · Exercise, Addictive Behaviors · 18 Years
Registered intervention descriptionVIP CM: Participants will receive progressively increasing CM for walking 10,000 steps per day over 4 days prior to visit as verified by the pedometer.
Registered arm groupsVIP CM
Registered study designVIP Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
NCT00780624 · NA · COMPLETED · Respiratory Distress Syndrome · 1 Minute · 28 Days
Registered intervention descriptionNIPPV: Ventilator is Bird VIP.
NIPPV: Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
NIPPV: Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
Registered arm groupsControl, NIPPV
Registered study designVIP Treatment of Acute Tracheitis and Laryngitis With Essential Oils of Aromatic Plants
NCT00611390 · PHASE1, PHASE2 · COMPLETED · Viral Laryngitis, Viral Tracheitis · 18 Years
Registered intervention descriptionplacebo: 0.1% of Lemon VIP (Florasynth,Israel), spraying to the larynx.
Registered arm groups2
Registered study designVIP Treatment of Acute Rhino-Sinusitis With Essential Oils of Aromatic Plants
NCT00610779 · PHASE1, PHASE2 · COMPLETED · Rhino-Sinusitis · 18 Years
Registered intervention descriptionplacebo: 0.1% of Lemon VIP (Florasynth,Israel), spraying to the nose.
Registered arm groups2