NCT06858839Active, not recruitingPhase 3
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Amgen
- Enrollment
- 3,853
- Locations
- 239
- Primary Endpoint
- Percent Change From Baseline in Body Weight at Week 72
Study Overview
Brief Summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years.
- •Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- •History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion Criteria
- •Type 1 or Typ2 diabetes mellitus.
- •Obesity induced by other endocrinologic disorders.
- •Self-reported change in body weight > 5 kg within 90 days before screening.
- •Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type
- •History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
- •History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- •Lifetime history of suicide attempt.
Arms & Interventions
Maridebart Cafraglutide High Dose
Experimental
Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Intervention: Maridebart Cafraglutide (Drug)
Maridebart Cafraglutide Medium Dose
Experimental
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Intervention: Maridebart Cafraglutide (Drug)
Maridebart Cafraglutide Low Dose
Experimental
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Intervention: Maridebart Cafraglutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo SC for 72 weeks.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Body Weight at Week 72
Time Frame: Baseline and Week 72
Secondary Outcomes
- Change From Baseline in Waist Circumference at Week 72(Baseline and Week 72)
- Participant achieving ≥ 5% reduction in body weight from baseline at week 72(Week 72)
- Participant achieving ≥ 10% reduction in body weight from baseline at week 72(Week 72)
- Participant achieving ≥ 15% reduction in body weight from baseline at week 72(Week 72)
- Participant achieving ≥ 20% reduction in body weight from baseline at week 72(Week 72)
- Change From Baseline in Systolic Blood Pressure (SBP) at Week 72(Baseline and Week 72)
- Percent Change From Baseline in Fasting Triglycerides at Week 72(Baseline and Week 72)
- Change From Baseline in Fasting Glucose at Week 72(Baseline and Week 72)
- Change From Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72(Baseline and Week 72)
- Change From Baseline in Body Weight at Week 72(Baseline and Week 72)
- Change From Baseline in Body Mass Index (BMI) at Week 72(Baseline and Week 72)
- Change From Baseline in Hemoglobin A1c at Week 72(Baseline and Week 72)
- Percent Change From Baseline in Fasting Insulin at Week 72(Baseline and Week 72)
- Change From Baseline in Glycemic Status at Week 72(Baseline and Week 72)
- Percent Change From Baseline in Fasting Lipid Parameters at Week 72(Baseline and Week 72)
- Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72(Baseline and Week 72)
- Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72(Baseline and Week 72)
- Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72(Baseline and Week 72)
- Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)(Up to approximately 88 weeks)
- Plasma Concentration of Maridebart Cafraglutide at Week 72(Week 72)
Investigators
Study Sites (239)
Loading locations...
Similar Trials
Active, not recruiting
Phase 3
Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND)NCT06553768Mirum Pharmaceuticals, Inc.90
Completed
Phase 3
Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IFShort Bowel SyndromeNCT04627025VectivBio AG164
Recruiting
Phase 3
Efficacy and Safety of a New Formulation of Oral Cladribine Compared With Placebo in Participants With Generalized Myasthenia Gravis (MyClad)Generalized Myasthenia GravisNCT06463587Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany264
Completed
Phase 3
A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisNCT03971422UCB Biopharma SRL200
Completed
Phase 3
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)Respiratory Syncytial Virus InfectionsNCT03979313AstraZeneca3,012