Phase 2b Study of Maridebart Cafraglutide Injections in Adults With High Liver Fat and Overweight or Obesity

What this Trial Is About

Researchers are evaluating maridebart cafraglutide in adults living with overweight or obesity and elevated liver fat to determine if it is better than a placebo in reducing liver fat content and body weight. This Phase 2b randomized, double-blind, placebo-controlled trial aims to assess the drugs efficacy, safety, and tolerability when combined with a reduced-calorie diet and increased physical activity. Participants include adults aged 18 to 99 with specific body mass index and liver fat requirements. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo as subcutaneous injections every 4 weeks for 52 weeks. Both groups will follow a reduced-calorie diet and increase physical activity during the study. The trial includes two groups one receiving the experimental drug and the other receiving placebo, allowing comparison of their effects on liver fat and body weight. During the study, participants will undergo various assessments including MRI scans to measure liver fat content and body composition, blood tests for liver enzymes and glucose control markers, and weight measurements at baseline, 24 weeks, and 52 weeks. Researchers will monitor treatment-emergent adverse events and serious adverse events throughout the study, which lasts approximately 69 weeks from screening to completion. This monitoring ensures participant safety and collects data on the drugs effects over time.

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