Phase 3 Study Evaluating Maridebart Cafraglutide Compared to Placebo in Adults with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Overweight or Obesity

What this Trial Is About

Researchers are evaluating the efficacy and safety of maridebart cafraglutide compared to placebo over 52 weeks in adults with obstructive sleep apnea OSA who are receiving positive airway pressure PAP therapy and have overweight or obesity. This Phase 3 trial aims to study the treatment effects in this specific population to improve management of OSA alongside current PAP therapy. Participants are randomly assigned to receive either maridebart cafraglutide or a placebo as subcutaneous injections. The study runs for 52 weeks, during which participants continue their PAP therapy while receiving the study drug or placebo. The trial includes a double-blind design to compare outcomes between the two groups over the treatment period. During the study, participants undergo various assessments including polysomnography to measure the Apnea-Hypopnea Index AHI, body weight measurements, blood pressure, blood tests for cholesterol, insulin, and glucose levels, as well as patient-reported sleep-related outcomes. Researchers monitor treatment-emergent adverse events and drug plasma levels, with evaluations occurring at multiple time points including weeks 24, 48, and 52. The total participation duration extends up to about 100 weeks for safety follow-up and outcome evaluation.

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy