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

What this study is about

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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Who can join (things the study team will check)

✅ You may be able to join if…

• AHI ≥ 15 on polysomnography at day 1 before randomization.
• BMI ≥ 27 kg/m\^2 at screening.
• History of at least 1 unsuccessful attempt at weight loss by diet and exercise.
• On positive airway pressure (PAP) therapy for at least 3 consecutive months before screening and plan to continue PAP therapy during the trial.

🚫 You may not be able to join if…

• Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
• Significant craniofacial abnormalities that may affect breathing at screening.
• Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
• Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
• Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.
• Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.

Where this trial is running

• Valley Clinical Trials, Northridge, California, United States
• Peninsula Research Associates, Rolling Hills Estates, California, United States
• Teradan Clinical Trials, Brandon, Florida, United States
• Destiny Research Center, Palmetto Bay, Florida, United States
• Clinical Research Center Of Florida, Pompano Beach, Florida, United States
• NeuroTrials Research, Atlanta, Georgia, United States
• Basil Clinical, Laurelton, New York, United States
• Monroe Biomedical Research, Monroe, North Carolina, United States
• CTI Clinical Research Center, Cincinnati, Ohio, United States
• FutureSearch Trials of Neurology, Austin, Texas, United States
• Epic Medical Research - DeSoto, DeSoto, Texas, United States
• Sleep Therapy & Research Center, San Antonio, Texas, United States

+ 48 more sites.

Who to contact

Amgen Call Center · 866-572-6436 · medinfo@amgen.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07225686.