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NCT07441252PHASE2Recruiting

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

Amgen

Start Date

3/5/2026

Completion Date

12/22/2027

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.

Eligibility Criteria

Age Range: 18 years to 99 years

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).

Interventions

DRUG

Maridebart cafraglutide

DRUG

Placebo

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Conditions

Overweight or Obesity and Elevated Liver Fat

Locations

Arizona Clinical Trials

Chandler, Arizona 85224

United States

Medical Advancement Centers of Arizona

Phoenix, Arizona 85044

United States

Del Sol Research Management

Tucson, Arizona 85715

United States

San Fernando Valley Health Institute

Canoga Park, California 91304

United States

Gastroenterology and Liver Institute

Escondido, California 92025

United States

Inland Empire Liver Foundation

Rialto, California 92377

United States

Apex Clinical Research

San Diego, California 92120

United States

University of Florida College of Medicine-Jacksonville

Gainesville, Florida 32610

United States

Floridian Clinical Research LLC

Miami Lakes, Florida 33016

United States

Indago Research and Health Center

Miami Lakes, Florida 33016

United States

Gastrointestinal Specialists- Louisiana Research Center- Highland

Shreveport, Louisiana 71105

United States

Woodholme Gastroenterology Associates - Glen Burnie

Glen Burnie, Maryland 21061

United States

Alliance for Multispecialty Research - Kansas City

Kansas City, Missouri 64114

United States

Excel Clinical Research

Las Vegas, Nevada 89109

United States

Bellaire Clinical Research

Bellaire, Texas 77401

United States

Juno Research LLC

Bellaire, Texas 77401

United States

Pinnacle Clinical Research - Corpus Christi

Corpus Christi, Texas 78404

United States

South Texas Research Institute

Edinburg, Texas 78539

United States

Houston Research Institute

Houston, Texas 77079

United States

Houston Research Institute - Pasadena

Pasadena, Texas 77505

United States

McAllen Research

Pharr, Texas 78557

United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas 78215

United States

Pinnacle Clinical Research

San Antonio, Texas 78229

United States