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Maridebart cafraglutide to lower liver fat and body weight in adults with overweight or obesity

Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight

Phase 2 Interventional Amgen · NCT07441252

This will test whether maridebart cafraglutide can reduce liver fat and help adults with overweight or obesity lose weight when given with a reduced-calorie diet and increased physical activity.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Locations18 sites (Chandler, Arizona and 17 other locations)
Trial IDNCT07441252 on ClinicalTrials.gov

What this trial studies

This Phase 2, randomized interventional trial compares maridebart cafraglutide with placebo in adults who have overweight or obesity and elevated liver fat. Participants must meet BMI and liver-fat criteria and will follow a reduced-calorie diet and increased physical activity while receiving study drug or placebo. Liver fat is measured centrally by MRI (with FibroScan CAP used for screening) and body weight is tracked to determine differences between groups. The main outcomes are change in liver fat content and body weight versus placebo.

Who should consider this trial

Good fit: Adults aged 18 or older with BMI 27–40 kg/m2, MRI-confirmed liver fat ≥10% and FibroScan CAP ≥300 dB/m, including those with stable, controlled type 2 diabetes on allowed medications, would be ideal candidates.

Not a fit: People with BMI outside 27–40, normal liver fat, type 1 or unstable diabetes, recent or planned bariatric/device obesity treatment, or recent malignancy are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, the drug could meaningfully reduce liver fat and body weight, which may improve metabolic health and lower risk of liver disease progression.

How similar studies have performed: Other incretin-based weight-loss drugs have shown reductions in liver fat and body weight in prior trials, but maridebart cafraglutide itself is a newer agent with limited published clinical results to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Chandler, Arizona and 17 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Overweight or Obesity and Elevated Liver FatObesityOverweightElevated liver fatAMG 133Maridebart cafraglutide
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.