DRUG
Maridebart cafraglutide
Maridebart cafraglutide will be administered as a SC injection.
Status
Recruiting
Phase
Phase 2
Enrollment
180
Locations
23
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Maridebart cafraglutide will be administered as a SC injection.
DRUG
Placebo will be administered as a SC injection.
Timeline
First posted
Feb 27, 2026
Study start
Mar 5, 2026
Primary completion
Sep 29, 2027
Study completion
Dec 22, 2027
Results posted
Not reported
Registry updated
Jun 18, 2026
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
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
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
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
No PMID-linked publications were present in this registry snapshot.
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