A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Purpose
The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.
Condition
- Overweight or Obesity and Elevated Liver Fat
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years. - Body Mass index (BMI) ≥ 27 kg/m^2 to ≤ 40 kg/m^2 at screening. - For participants with type 2 diabetes mellitus (T2DM) at screening: - HbA1c ≤ 9.5% (80 mmol/mol) at screening. - Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination. - Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment. - Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening. - MRI assessment should only be performed after all other eligibility has been confirmed whenever possible. - History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Exclusion Criteria
- Recent or planned surgical/device-based obesity treatment (<1 year). - History of malignancy within the past 5 years (exceptions apply). - Type 1 diabetes or non-type 2 diabetes mellitus (T2DM); unstable/severe hypoglycemia. - Advanced diabetic retinopathy or macular edema. - History of pancreatitis (acute <180 days or chronic). - History of medullary thyroid carcinoma (MTC) or MEN-2 - Major cardiovascular event within 60 days (e.g., myocardial infarction [MI], stroke, coronary artery bypass graft [CABG]). - New York Heart Association (NYHA) Class IV heart failure. - Unstable psychiatric disorders within 2 years. - Significant liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD) (e.g., hepatitis, cirrhosis, hepatic decompensation). - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 or on dialysis. - Patient Health Questionnaire-9 (PHQ-9) ≥ 15, or suicidal ideation/behavior (Columbia-Suicide Severity Rating Scale [C-SSRS]). - Inability to undergo MRI scan (e.g., due to metal implant, claustrophobia, or body size limitations).
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Maridebart Cafraglutide |
Participants will receive maridebart cafraglutide as a subcutaneous (SC) injection every 4 weeks (Q4W) for 52 weeks. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo as a SC injection Q4W for 52 weeks. |
|
Recruiting Locations
Arizona Clinical Trials
Chandler, Arizona 85224
Chandler, Arizona 85224
Medical Advancement Centers of Arizona
Phoenix, Arizona 85044
Phoenix, Arizona 85044
Indago Research and Health Center
Hialeah, Florida 33012
Hialeah, Florida 33012
Floridian Clinical Research LLC
Miami Lakes, Florida 33016
Miami Lakes, Florida 33016
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie, Maryland 21061
Glen Burnie, Maryland 21061
Excel Clinical Research
Las Vegas, Nevada 89109
Las Vegas, Nevada 89109
McAllen Research
Pharr, Texas 78557
Pharr, Texas 78557
More Details
- Status
- Recruiting
- Sponsor
- Amgen