Current partner codePEPTIDESDE
NCT07441252·Phase 2·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 2

Enrollment

180

Locations

23

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Maridebart cafraglutide

Maridebart cafraglutide will be administered as a SC injection.

DRUG

Placebo

Placebo will be administered as a SC injection.

Timeline

From registration to results.

  1. First posted

    Feb 27, 2026

  2. Study start

    Mar 5, 2026

  3. Primary completion

    Sep 29, 2027

  4. Study completion

    Dec 22, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 18, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline and Week 52

Percent Change from Baseline in Body Weight at Week 52

Time frame · Baseline and Week 52

Secondary outcomes

Number of Participants Achieving ≥ 30% Reduction from Baseline in Liver Fat Content (LFC) by MRI at Week 52

Time frame · Baseline and Week 52

Percent Change from Baseline in Visceral Adipose Tissue (VAT) Volume by MRI at Week 52

Time frame · Baseline and Week 52

Number of Participants Achieving < 5% LFC by MRI at Week 52

Time frame · Week 52

Change from Baseline in LFC by MRI at Week 52

Time frame · Baseline and Week 52

Percent Change from Baseline in LFC by MRI at Week 24

Time frame · Baseline and Week 24

Change from Baseline in LFC by MRI at Week 24

Time frame · Baseline and Week 24

Percent Change from Baseline in Thigh Muscle Volume by MRI at Week 24 and Week 52

Time frame · Baseline, Week 24, and 52

Percent Change from Baseline in Thigh Muscle Fat Fraction by MRI at Week 24 and Week 52

Time frame · Baseline, Week 24, and 52

Percent Change from Baseline in Thigh Intermuscular and Intramuscular Fat Volume by MRI at Week 24 and Week 52

Time frame · Baseline, Week 24, and 52

Percent Change from Baseline in Abdominal Subcutaneous Adipose Tissue (ASAT) Volume by MRI at Week 52

Time frame · Baseline and Week 52

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
99 Years
Sex
ALL
Healthy volunteers
No

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).

Study locations

23 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Arizona Clinical Trials

Chandler, Arizona, United States

Medical Advancement Centers of Arizona

Phoenix, Arizona, United States

Del Sol Research Management

Tucson, Arizona, United States

San Fernando Valley Health Institute

Canoga Park, California, United States

Gastroenterology and Liver Institute

Escondido, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Apex Clinical Research

San Diego, California, United States

University of Florida College of Medicine-Jacksonville

Gainesville, Florida, United States

Floridian Clinical Research LLC

Miami Lakes, Florida, United States

Indago Research and Health Center

Miami Lakes, Florida, United States

Gastrointestinal Specialists- Louisiana Research Center- Highland

Shreveport, Louisiana, United States

Woodholme Gastroenterology Associates - Glen Burnie

Glen Burnie, Maryland, United States

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri, United States

Excel Clinical Research

Las Vegas, Nevada, United States

Bellaire Clinical Research

Bellaire, Texas, United States

Juno Research LLC

Bellaire, Texas, United States

Pinnacle Clinical Research - Corpus Christi

Corpus Christi, Texas, United States

South Texas Research Institute

Edinburg, Texas, United States

Houston Research Institute

Houston, Texas, United States

Houston Research Institute - Pasadena

Pasadena, Texas, United States

McAllen Research

Pharr, Texas, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Pinnacle Clinical Research

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.