Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure 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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.
Conditions
- Obesity
- Obstructive Sleep Apnea
Eligibility
- Eligible Ages
- Between 18 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
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 5388601, California 5332921 90274
Rolling Hills Estates 5388601, California 5332921 90274
Teradan Clinical Trials
Brandon 4148757, Florida 4155751 33511
Brandon 4148757, Florida 4155751 33511
Destiny Research Center
Palmetto Bay 4167634, Florida 4155751 33157
Palmetto Bay 4167634, Florida 4155751 33157
Clinical Research Center Of Florida
Pompano Beach 4169014, Florida 4155751 33060
Pompano Beach 4169014, Florida 4155751 33060
Basil Clinical
Laurelton 5124078, New York 5128638 11413
Laurelton 5124078, New York 5128638 11413
Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112
Monroe 4479946, North Carolina 4482348 28112
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
Sleep Therapy & Research Center
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Northwest Clinical Research Center
Bellevue 5786882, Washington 5815135 98007
Bellevue 5786882, Washington 5815135 98007
More Details
- Status
- Recruiting
- Sponsor
- Amgen