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Maridebart cafraglutide versus placebo for adults with obstructive sleep apnea who are overweight or obese and not using PAP

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)

Phase 3 Interventional Amgen · NCT07226765

This study will test whether maridebart cafraglutide helps adults with obstructive sleep apnea who are overweight or obese and not using PAP therapy, compared with placebo over 52 weeks.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years to 99 Years
SexAll
SponsorAmgen Industry-sponsored
Locations42 sites (Northridge, California and 41 other locations)
Trial IDNCT07226765 on ClinicalTrials.gov

What this trial studies

This is a Phase 3, randomized, placebo-controlled trial comparing maridebart cafraglutide to placebo over 52 weeks in adults with obstructive sleep apnea who are not on PAP therapy. Eligible participants must have an apnea–hypopnea index (AHI) ≥15 on polysomnography and a BMI ≥27 kg/m2, with a history of at least one unsuccessful weight-loss attempt. Participants are randomized to receive maridebart cafraglutide or matching placebo and are monitored periodically for changes in OSA severity, body weight, and safety outcomes. Study visits and testing (including baseline and follow-up PSG) occur at clinical sites in California and Florida.

Who should consider this trial

Good fit: Adults with moderate-to-severe OSA (AHI ≥15) who have BMI ≥27 kg/m2, have tried weight loss, and are not using or planning to use PAP therapy are the intended participants.

Not a fit: People with predominant central apnea (≥50% central events), Cheyne–Stokes respiration, active PAP or oral appliance treatment, prior or planned upper airway surgery, or significant craniofacial abnormalities are unlikely to benefit from this study treatment.

Why it matters

Potential benefit: If successful, the drug could reduce OSA severity and symptoms by promoting weight loss and airway improvement, offering a non‑PAP treatment option for patients unwilling or unable to use PAP.

How similar studies have performed: Other weight-loss drugs, particularly GLP-1 receptor agonists, have produced significant weight loss and modest improvements in OSA in smaller studies, but large phase 3 results specifically targeting OSA remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must have an AHI of 15 or higher on polysomnography (PSG) at Day 1 before randomization.
* Body Mass Index (BMI) of 27 kg/m\^2 or more at the time of screening.
* History of at least one unsuccessful attempt at weight loss through diet and exercise.
* Participants must not have used PAP therapy for at least 4 weeks before screening, are unwilling/unable to use PAP, and do not plan to use PAP therapy during the study.

Exclusion Criteria:

* Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
* Those with significant craniofacial abnormalities that may affect breathing at screening.
* Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.
* Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.
* Individuals with respiratory diseases like obesity hypoventilation syndrome or daytime hypercapnia, neuromuscular diseases or other conditions that could interfere with the trial results, according to the investigator's opinion.

Where this trial is running

Northridge, California and 41 other locations

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 Obstructive Sleep ApneaObstructive sleep apneaOSAOverweightObesityMaridebart CafraglutideAMG 133MariTide
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.