Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
NCT07225686 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250
Last updated 2026-05-22
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
- DRUG
-
Maridebart cafraglutide
Participants will receive maridebart cafraglutide as SC injections.
- DRUG
-
Participants will receive placebo SC.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-19
- Primary Completion
- 2027-09-29
- Completion
- 2028-09-13
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- Czechia
- France
- Germany
- Hungary
- Japan
- Poland
- Spain
Study Locations
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