Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea
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.
| Condition(s) | Obstructive Sleep Apnea |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: * Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization. * Body Mass Index (BMI) of 27 kg/m\^2 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. Exclusion Criteria: * 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, |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Lead sponsor | Amgen |
| Locations | Northridge, California, United States; Rolling Hills Estates, California, United States; Brandon, Florida, United States; Palmetto Bay, Florida, United States; Pompano Beach, Florida, United States; Atlanta, Georgia, United States (+48 more sites) |
| Start date | 2025-11-25 |
| NCT ID | NCT07226765 |
| Official listing | https://clinicaltrials.gov/study/NCT07226765 |