RecruitingObstructive Sleep Apnea
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Eligible age
18–99 yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Amgen
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
- ✕ Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.
Where it's recruiting
California
Northridge · Rolling Hills Estates
Florida
Brandon · Palmetto Bay · Pompano Beach
Georgia
Atlanta
New York
Laurelton
North Carolina
Monroe
Ohio
Cincinnati
Texas
Austin · DeSoto · San Antonio
Washington
Bellevue
Source: ClinicalTrials.gov · NCT07226765 · last updated 2026-06-12