Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight
Amgen
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
- Age range
- 18–99 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 al…
Interventions
- DrugMaridebart cafraglutide
Maridebart cafraglutide will be administered as a SC injection.
- DrugPlacebo
Placebo will be administered as a SC injection.
Locations (18)
- Arizona Clinical TrialsChandler, Arizona
- Medical Advancement Centers of ArizonaPhoenix, Arizona
- Gastroenterology and Liver InstituteEscondido, California
- Inland Empire Liver FoundationRialto, California
- Apex Clinical ResearchSan Diego, California
- University of Florida College of Medicine-JacksonvilleGainesville, Florida