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 Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)
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 not on PAP therapy and are living with overweight or obesity.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- 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 sur…
Interventions
- DrugMaridebart cafraglutide
Participants will receive maridebart cafraglutide SC.
- DrugPlacebo
Participants will receive placebo SC.
Locations (42)
- 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