Back to search results

Maridebart Cafraglutide for Obstructive Sleep Apnea

This study is testing a drug called maridebart cafraglutide against a placebo (an inactive substance) for adults with obstructive sleep apnea (OSA). OSA is a condition where breathing repeatedly stops and starts during sleep. You might be able to join if you are between 18 and 99 years old, have an Apnea-hypopnea Index (AHI) of 15 or higher, a Body Mass Index (BMI) of 27 or more, and have tried to lose weight before without success. The main goal is to see if maridebart cafraglutide can reduce your AHI after 52 weeks. This study is for people with OSA who are not using a CPAP machine or similar breathing device.

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

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07226765

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy

Recruiting
PHASE3Ages 18–99InterventionalTreatment
Amgen
~250 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Maridebart cafraglutidePlacebo

At a glance

Recruiting sites
57 of 57 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

Obstructive Sleep Apnea

Explore related trials

ObesityObstructive Sleep Apnea

Where it's being run

57 sites across 34 states
Germany6
Florida3
Texas3
São Paulo3
Czechia3
France3
Hungary3
Poland3

Study leadership

  • MD · STUDY_DIRECTOR · Amgen

Who to contact

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

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

Individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for OSA.
Those with significant craniofacial abnormalities that may affect breathing at screening.
Participants diagnosed with 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 or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
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.

What this trial measures

  • Change in Apnea-hypopnea Index (AHI) from baseline at Week 52At Week 52