Maridebart cafraglutide versus placebo for adults with obstructive sleep apnea on PAP therapy

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 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.

Why it matters

Who can join: the full rules

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 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

+1 more sites. See ClinicalTrials.gov for the full list.

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.