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Maridebart Cafraglutide for Obstructive Sleep Apnea

This study is testing a drug called maridebart cafraglutide for adults with obstructive sleep apnea (OSA) who are also using a positive airway pressure (PAP) machine and are overweight or have obesity. You might be able to join if you are between 18 and 99 years old, have moderate to severe OSA, a BMI of 27 or higher, and have tried to lose weight before. You also need to have been using PAP therapy for at least three months. The study will compare maridebart cafraglutide to a placebo (an inactive substance) over 52 weeks to see if it can improve your AHI (Apnea-Hypopnea Index), which measures how often your breathing stops or gets very shallow during sleep. The study plans to enroll 250 participants, but its current recruitment status is unclear.

Study design
This is a Phase 3 interventional study comparing maridebart cafraglutide to a placebo. It plans to enroll 250 adult participants.
What's involved
Participants will receive maridebart cafraglutide or placebo through injections under the skin for 52 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at week 52, indicating follow-up for at least this duration.

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NCT07225686

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

Recruiting
PHASE3Ages 18–99InterventionalTreatment
Amgen
~250 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Maridebart cafraglutidePlacebo

At a glance

Recruiting sites
61 of 61 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
Measured over At week 52

Conditions

Obesity
Obstructive Sleep Apnea

Explore related trials

ObesityObstructive Sleep Apnea

Where it's being run

61 sites across 34 states
Germany6
France5
Hungary5
Florida3
Texas3
São Paulo3
Czechia3
Poland3

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

Amgen Call Center
[email protected]
866-572-6436
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Had any previous or planned upper airway surgery or major ear, nose, or throat surgery for OSA.
Significant craniofacial abnormalities that may affect breathing at screening.
Diagnosis of Central or Mixed Sleep Apnea with proportion of mixed or central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
Active device treatment of OSA other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
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.

What this trial measures

  • Change in Apnea-Hypopnea Index (AHI) from baseline at week 52At week 52