Clinical trial
A Trial to Evaluate Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat and Obesity or Overweight
Recruiting now · Phase 2 · 1 countries · Registry ID NCT07441252
Recruiting nowPhase 2Interventional
What this study is about
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.
A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.
Basic eligibility
Age18 Years to 99 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obesity and Elevated Liver Fat
Full registry criteria
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).
Treatments and study arms
Maridebart cafraglutide
Drug
Maridebart cafraglutide will be administered as a SC injection.
Placebo
Drug
Placebo will be administered as a SC injection.
Primary outcomes
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
Study locations
23 locations were listed when this page was built. The first 40 are shown.
Bellaire Clinical Research🇺🇸 Bellaire, Texas, United States
Juno Research LLC🇺🇸 Bellaire, Texas, United States
San Fernando Valley Health Institute🇺🇸 Canoga Park, California, United States
Arizona Clinical Trials🇺🇸 Chandler, Arizona, United States
Pinnacle Clinical Research - Corpus Christi🇺🇸 Corpus Christi, Texas, United States
South Texas Research Institute🇺🇸 Edinburg, Texas, United States
Gastroenterology and Liver Institute🇺🇸 Escondido, California, United States
University of Florida College of Medicine-Jacksonville🇺🇸 Gainesville, Florida, United States
Woodholme Gastroenterology Associates - Glen Burnie🇺🇸 Glen Burnie, Maryland, United States
Houston Research Institute🇺🇸 Houston, Texas, United States
Alliance for Multispecialty Research - Kansas City🇺🇸 Kansas City, Missouri, United States
Excel Clinical Research🇺🇸 Las Vegas, Nevada, United States
Floridian Clinical Research LLC🇺🇸 Miami Lakes, Florida, United States
Indago Research and Health Center🇺🇸 Miami Lakes, Florida, United States
Houston Research Institute - Pasadena🇺🇸 Pasadena, Texas, United States
McAllen Research🇺🇸 Pharr, Texas, United States
Medical Advancement Centers of Arizona🇺🇸 Phoenix, Arizona, United States
Inland Empire Liver Foundation🇺🇸 Rialto, California, United States
American Research Corporation at the Texas Liver Institute🇺🇸 San Antonio, Texas, United States
Pinnacle Clinical Research🇺🇸 San Antonio, Texas, United States
Apex Clinical Research🇺🇸 San Diego, California, United States
Gastrointestinal Specialists- Louisiana Research Center- Highland🇺🇸 Shreveport, Louisiana, United States
Del Sol Research Management🇺🇸 Tucson, Arizona, United States