A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated… (NCT07441252) | Clinical Trial Compass
RecruitingPhase 2
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
United States180 participantsStarted 2026-03-05
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Timeframe: Baseline and Week 52
2
Percent Change from Baseline in Body Weight at Week 52