Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

Not Applicable

Not yet recruiting

• Conditions: Obesity; Obstructive Sleep Apnea
• Interventions: Drug: Maridebart cafraglutide; Drug: Placebo

• Registration Number: NCT07225686
• Lead Sponsor: Amgen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-05
• Study First Submitted QC: 2025-11-05
• Last Update Submitted: 2025-11-05
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2025-12-17
• Primary Completion: 2027-09-29
• Study Completion: 2028-09-13

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 250

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 apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
• Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
• Respiratory diseases such as obesity hypoventilation syndrome or daytime hypercapnia, or neuromuscular diseases such as myasthenia gravis or other conditions that could interfere with the results of the trial in the opinion of the investigator.
• Have personal circumstances or job-related responsibilities that prevent a 7-day PAP withdrawal before polysomnography testing during the course of the trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maridebart Cafraglutide	Maridebart cafraglutide	Participants will receive maridebart cafraglutide subcutaneously (SC).
Placebo	Placebo	Participants will receive placebo SC.

Primary Outcome Measures

Name	Time	Method
Change in AHI from baseline at week 52	At Week 52

Secondary Outcome Measures

Name	Time	Method
Percentage Change in AHI from baseline at week 52	At Week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at week 52	At Week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52	At Week 52
Percentage Change in Body Weight from baseline at Week 52	At Week 52
Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52	At Week 52
Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52	At Week 52
Change in Systolic Blood Pressure from baseline at Week 48	At Week 48
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52	At Week 52