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Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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 on Positive Airway Pressure Therapy and Living With Overweight or Obesity

NCT07225686•Amgen

View on ClinicalTrials.gov

Summary

This Phase 3 clinical trial is designed to evaluate the efficacy and safety of maridebart cafraglutide compared to placebo over a 52-week period in adults with obstructive sleep apnea (OSA) who are receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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.

Locations (28)

Peninsula Research Associates

Rolling Hills Estates, California, United States

Teradan Clinical Trials

Brandon, Florida, United States

Destiny Research Center

Palmetto Bay, Florida, United States

Clinical Research Center Of Florida

Pompano Beach, Florida, United States

Basil Clinical

Laurelton, New York, United States

Monroe Biomedical Research

Monroe, North Carolina, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Epic Medical Research - DeSoto

DeSoto, Texas, United States

Sleep Therapy & Research Center

San Antonio, Texas, United States

Key Dates

Start Date

December 19, 2025

Primary Completion Date

September 29, 2027

Completion Date

September 13, 2028

Last Updated

March 6, 2026

Enrollment

250

ESTIMATED participants

Conditions

ObesityObstructive Sleep Apnea

Interventions

Maridebart cafraglutide

DRUG

Placebo

DRUG

Contacts

Amgen Call Center

CONTACT

866-572-6436 medinfo@amgen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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