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 range
18 Years – 99 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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