Back to search results

Maridebart Cafraglutide for Elevated Liver Fat and Obesity

This study is testing a drug called maridebart cafraglutide to see if it can help reduce liver fat and body weight in adults who have elevated liver fat and are overweight or have obesity. Participants will receive either maridebart cafraglutide or a placebo (an inactive substance) through injections under the skin, along with a reduced-calorie diet and increased physical activity. We'll measure changes in liver fat using a special MRI scan and changes in body weight after 52 weeks. You may be able to join if you are between 18 and 99 years old, have a BMI between 27 and 40, and meet other health criteria. The study is currently recruiting 180 participants.

Study design
This interventional study plans to enroll 180 participants. It compares maridebart cafraglutide to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Liver fat and body weight will be measured at the start of the study and again at Week 52.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07441252

A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight

Recruiting
PHASE2Ages 18–99InterventionalTreatment
Amgen
~180 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Maridebart cafraglutidePlacebo

At a glance

Recruiting sites
23 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52
Measured over Baseline and Week 52
+1 more outcome measured

Conditions

Overweight or Obesity and Elevated Liver Fat

Explore related trials

Nonalcoholic Fatty Liver DiseaseObesityOverweight

Where it's being run

23 sites across 8 states
Texas9
California4
Arizona3
Florida3
Louisiana1
Maryland1
Missouri1
Nevada1

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Percent Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) at Week 52Baseline and Week 52
  • Percent Change from Baseline in Body Weight at Week 52Baseline and Week 52