A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living With Overweight or Obesity
Amgen
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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- 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 a…
Interventions
- DrugMaridebart cafraglutide
Participants will receive maridebart cafraglutide as SC injections.
- DrugPlacebo
Participants will receive placebo SC.
Locations (51)
- Valley Clinical TrialsNorthridge, California
- Peninsula Research AssociatesRolling Hills Estates, California
- Teradan Clinical TrialsBrandon, Florida
- Destiny Research CenterPalmetto Bay, Florida
- Clinical Research Center Of FloridaPompano Beach, Florida
- NeuroTrials ResearchAtlanta, Georgia