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Recruiting Phase 2 NCT07441252

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

Phase 2 – studying effectiveness and dosage
Conditions: Overweight or Obesity and Elevated Liver Fat

Sponsor: Amgen

trial.available_in: БГ
Overview
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.
Who can participate
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
Maridebart cafraglutide
DRUG
Placebo
DRUG
Locations 15
United States (15)
Arizona Clinical Trials
Chandler , Arizona
Pinnacle Clinical Research - Corpus Christi
Corpus Christi , Texas
South Texas Research Institute
Edinburg , Texas
University of Florida College of Medicine-Jacksonville
Gainesville , Florida
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie , Maryland
Indago Research and Health Center
Hialeah , Florida
Houston Research Institute
Houston , Texas
Excel Clinical Research
Las Vegas , Nevada
Floridian Clinical Research LLC
Miami Lakes , Florida
Houston Research Institute - Pasadena
Pasadena , Texas
McAllen Research
Pharr , Texas
Medical Advancement Centers of Arizona
Phoenix , Arizona
Inland Empire Liver Foundation
Rialto , California
Pinnacle Clinical Research
San Antonio , Texas
Apex Clinical Research
San Diego , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No
Start date
05.03.2026
Completion date
22.12.2027
Registry ID
NCT07441252
Source
clinicaltrials.gov
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