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Maridebart cafraglutide versus placebo for adults with obstructive sleep apnea on 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 on Positive Airway Pressure Therapy and Living With Overweight or Obesity

Phase 3 Interventional Amgen · NCT07225686

This study will test whether maridebart cafraglutide helps adults with obstructive sleep apnea who use positive airway pressure therapy and are overweight or obese over 52 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Locations51 sites (Northridge, California and 50 other locations)
Trial IDNCT07225686 on ClinicalTrials.gov

What this trial studies

This Phase 3 trial compares maridebart cafraglutide to a matching placebo over 52 weeks in adults with obstructive sleep apnea who are receiving positive airway pressure (PAP) therapy and have BMI ≥ 27. Eligible participants must have an apnea–hypopnea index (AHI) ≥ 15, a history of at least one unsuccessful weight-loss attempt, and have used PAP therapy for at least three consecutive months. Participants receive the study drug or placebo while continuing PAP therapy, and investigators monitor safety, body weight, and measures of sleep-disordered breathing. The trial is conducted at outpatient clinical research sites in the United States.

Who should consider this trial

Good fit: Adults with obstructive sleep apnea (AHI ≥ 15) who are overweight or obese (BMI ≥ 27), have previously tried and not sustained weight loss, and have been on PAP therapy for at least three months are ideal candidates.

Not a fit: Patients whose breathing disorder is primarily central apnea, those with significant craniofacial abnormalities, recent or planned upper airway surgery, active non‑PAP OSA treatments that cannot be stopped, or people who are not overweight are unlikely to receive benefit from this trial.

Why it matters

Potential benefit: If successful, maridebart cafraglutide could help people with obesity and OSA lose weight and reduce the severity of sleep apnea while continuing PAP therapy.

How similar studies have performed: Other GLP‑1–class weight-loss medications have produced substantial weight loss and shown improvements in sleep apnea measures in prior studies, though this specific compound is being evaluated separately in a Phase 3 program.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Northridge, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityObstructive Sleep ApneaMariTideMaridebart CafraglutideAMG 133
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.