Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
- Registration Number
- NCT06858839
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3501
- 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.
- 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 2.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maridebart Cafraglutide High Dose Maridebart Cafraglutide Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. Maridebart Cafraglutide Medium Dose Maridebart Cafraglutide Participants will receive maridebart cafraglutide medium dose SC for 72 weeks. Maridebart Cafraglutide Low Dose Maridebart Cafraglutide Participants will receive maridebart cafraglutide low dose SC for 72 weeks. Placebo Placebo Participants will receive placebo SC for 72 weeks.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight at Week 72 Baseline and Week 72
- Secondary Outcome Measures
Name Time Method 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 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 The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
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 Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C).
Change From Baseline in Diastolic Blood Pressure (DBP) 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 The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.
Plasma Concentration of Maridebart Cafraglutide at Week 72 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 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 Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 Baseline and Week 72 Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately 88 weeks
Related Research Topics
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Trial Locations
- Locations (239)
Pinnacle Research Group LLC
🇺🇸Anniston, Alabama, United States
Alliance For Multispecialty Research - Daphne
🇺🇸Daphne, Alabama, United States
Alliance for Multispecialty Research Mobile
🇺🇸Mobile, Alabama, United States
Avacare Foothills Research Center
🇺🇸Phoenix, Arizona, United States
Ark Clinical Research- Tustin
🇺🇸Fountain Valley, California, United States
Long Beach Clinical Trials Services Inc
🇺🇸Long Beach, California, United States
Ark Clinical Research- Long Beach
🇺🇸Long Beach, California, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Apex Clinical Research
🇺🇸San Diego, California, United States
Scroll for more (229 remaining)Pinnacle Research Group LLC🇺🇸Anniston, Alabama, United States