Trials / Recruiting
RecruitingNCT07226765
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) 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 Not on Positive Airway Pressure Therapy and Living With Overweight or Obesity (MARITIME-OSA-2)
- 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 not on PAP therapy and are living with overweight or obesity.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Maridebart cafraglutide | Participants will receive maridebart cafraglutide SC. |
| DRUG | Placebo | Participants will receive placebo SC. |
Timeline
- Start date
- 2025-11-25
- Primary completion
- 2027-09-29
- Completion
- 2028-09-13
- First posted
- 2025-11-10
- Last updated
- 2026-04-16
Locations
34 sites across 7 countries: United States, Australia, Canada, Czechia, Germany, Japan, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07226765. Inclusion in this directory is not an endorsement.