Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Purpose
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
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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, 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Maridebart Cafraglutide |
Participants will receive maridebart cafraglutide subcutaneously (SC). |
|
|
Placebo Comparator Placebo |
Participants will receive placebo SC. |
|
Recruiting Locations
Peninsula Research Associates
Rolling Hills Estates, California 90274
Rolling Hills Estates, California 90274
Teradan Clinical Trials
Brandon, Florida 33511
Brandon, Florida 33511
Destiny Research Center
Palmetto Bay, Florida 33157
Palmetto Bay, Florida 33157
Clinical Research Center Of Florida
Pompano Beach, Florida 33060
Pompano Beach, Florida 33060
Basil Clinical
Laurelton, New York 11413
Laurelton, New York 11413
Monroe Biomedical Research
Monroe, North Carolina 28112
Monroe, North Carolina 28112
CTI Clinical Research Center
Cincinnati, Ohio 45212
Cincinnati, Ohio 45212
FutureSearch Trials of Neurology
Austin, Texas 78731
Austin, Texas 78731
Epic Medical Research - DeSoto
DeSoto, Texas 75115
DeSoto, Texas 75115
Sleep Therapy & Research Center
San Antonio, Texas 78229
San Antonio, Texas 78229
Northwest Clinical Research Center
Bellevue, Washington 98007
Bellevue, Washington 98007
More Details
- NCT ID
- NCT07226765
- Status
- Recruiting
- Sponsor
- Amgen