RecruitingOverweight or Obesity and Elevated Liver Fat
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Eligible age
18–99 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Amgen
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07441252 · last updated 2026-06-18