Phase 3 Study of Maridebart Cafraglutide Injection for Adults with Obstructive Sleep Apnea and Overweight or Obesity Not Using PAP Therapy

What this Trial Is About

Researchers are evaluating the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea OSA who are not using positive airway pressure PAP therapy and have overweight or obesity. This Phase 3 randomized, double-blind, placebo-controlled trial aims to understand how this treatment affects OSA severity and related health measures in this specific population. Participants will be randomly assigned to receive either maridebart cafraglutide or a placebo, both given as subcutaneous injections. The study treatment is administered throughout the 52-week period. The trial compares these two groups in parallel to assess the effects of the medication against placebo. During the study, participants will undergo various assessments including polysomnography to measure apnea-hypopnea index AHI, body weight monitoring, blood pressure checks, and patient-reported sleep impairment questionnaires. Safety and tolerability will be monitored, and researchers will track changes in markers such as sleep apnea severity, body weight, inflammation, and blood pressure over the 52 weeks of treatment.

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy