This Phase 3 clinical trial is designed to evaluate 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 on PAP therapy and are living with overweight or obesity.
Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.
Body Mass Index (BMI) of 27 kg/m² or more at the time of screening.
History of at least one unsuccessful attempt at weight loss through diet and exercise.
Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study.
Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
Those with significant craniofacial abnormalities that may affect breathing at screening.
Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.
Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.
Parallel
Maridebart cafraglutide
DrugParticipants will receive maridebart cafraglutide SC.
Placebo
DrugParticipants will receive placebo SC.
Change in Apnea-hypopnea Index (AHI) from baseline at Week 52
Percent Change in AHI from baseline at Week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at Week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at Week 52
Percent Change in Body Weight from baseline at Week 52
