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
Teradan Clinical Trials
Brandon 4148757, Florida 4155751 33511
Brandon 4148757, Florida 4155751 33511
CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212
Cincinnati 4508722, Ohio 5165418 45212
FutureSearch Trials of Neurology
Austin 4671654, Texas 4736286 78731
Austin 4671654, Texas 4736286 78731
Epic Medical Research - DeSoto
DeSoto 4685524, Texas 4736286 75115
DeSoto 4685524, Texas 4736286 75115
More Details
- NCT ID
- NCT07226765
- Status
- Recruiting
- Sponsor
- Amgen