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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Valley Clinical Trials
  Northridge, California, United States Recruiting
• Peninsula Research Associates
  Rolling Hills Estates, California, United States Recruiting
• Teradan Clinical Trials
  Brandon, Florida, United States Recruiting
• Destiny Research Center
  Palmetto Bay, Florida, United States Recruiting
• Clinical Research Center Of Florida
  Pompano Beach, Florida, United States Recruiting
• NeuroTrials Research
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.