Long-Term Phase 3 Extension Study of Maridebart Cafraglutide for Adults with Obesity or Overweight

What this Trial Is About

Researchers are evaluating the long-term effects of maridebart cafraglutide in adults with obesity or overweight. This extension study follows participants from a previous trial to assess the medications ongoing efficacy, safety, and tolerability over an extended period. The trial is designed as a phase 3 randomized and double-blind study to provide comprehensive information on treatment outcomes. Participants will receive different doses of maridebart cafraglutide administered by subcutaneous injection at varying intervals, including once every 4, 8, or 12 weeks. Some participants who received placebo or lower doses in the previous trial will undergo dose escalation or re-randomization to different dose groups or placebo. The study includes a dose-escalation phase for certain participants before initiating the assigned high dose. During the study, participants will be regularly monitored for changes in body weight compared to the original trial baseline, treatment-emergent adverse events, and serious adverse events. Additional assessments will track waist circumference, quality of life related to weight, and maintenance of weight loss. Participants are expected to complete visits and evaluations over approximately 48 weeks, with safety data collected up to 60 weeks from the start of the extension trial.

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)