Phase 3 Study of Switching from GLP-1 Receptor Agonists to Maridebart Cafraglutide in Adults with Obesity or Overweight

What this Trial Is About

This research aims to assess the effectiveness, safety, and tolerability of switching from glucagon-like peptide-1 receptor agonists GLP-1RA to maridebart cafraglutide in adults with obesity or overweight. The study focuses on adults with a body mass index of 25 or higher who have lost at least 10% of their body weight using weekly GLP-1RA treatment and have stable weight and gastrointestinal tolerability. Participants will be randomly assigned to one of two groups, each receiving a different dosing schedule of maridebart cafraglutide administered by subcutaneous injection during the treatment period. This is a phase 3, open-label trial with a parallel study model designed to evaluate the treatment effects over a period culminating at week 68. Throughout the study, participants will undergo assessments including body weight changes, plasma concentration of maridebart cafraglutide, and monitoring for treatment-emergent adverse events up to 84 weeks. The primary outcome measured is the percent change in body weight from baseline at week 68. Secondary outcomes include weight maintenance and safety evaluations, with participants expected to follow trial procedures for the entire duration.

Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)