Trials / Recruiting
RecruitingNCT07225686
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Maridebart cafraglutide | Participants will receive maridebart cafraglutide as SC injections. |
| DRUG | Placebo | Participants will receive placebo SC. |
Timeline
- Start date
- 2025-12-19
- Primary completion
- 2027-09-29
- Completion
- 2028-09-13
- First posted
- 2025-11-10
- Last updated
- 2026-04-16
Locations
45 sites across 11 countries: United States, Australia, Brazil, Canada, Czechia, France, Germany, Hungary, Japan, Poland, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07225686. Inclusion in this directory is not an endorsement.