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 or major ear, nose or throat surgery for OSA.
Those with significant craniofacial abnormalities that may affect breathing at screening.
Participants diagnosed with Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
Active device treatment of OSA or other treatments, that in the opinion of the investigator, may interfere with study outcomes.