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

NCT ID: NCT07225686

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-19

Study Completion Date

2028-09-13

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Maridebart Cafraglutide

Participants will receive maridebart cafraglutide subcutaneously (SC).

Group Type EXPERIMENTAL

Maridebart cafraglutide

Intervention Type DRUG

Participants will receive maridebart cafraglutide as SC injections.

Placebo

Participants will receive placebo SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will receive placebo SC.

Interventions

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Maridebart cafraglutide

Participants will receive maridebart cafraglutide as SC injections.

Intervention Type DRUG

Placebo

Participants will receive placebo SC.

Intervention Type DRUG

Other Intervention Names

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AMG 133

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status RECRUITING

Teradan Clinical Trials

Brandon, Florida, United States

Site Status RECRUITING

Destiny Research Center

Palmetto Bay, Florida, United States

Site Status RECRUITING

Clinical Research Center Of Florida

Pompano Beach, Florida, United States

Site Status RECRUITING

Basil Clinical

Laurelton, New York, United States

Site Status RECRUITING

Monroe Biomedical Research

Monroe, North Carolina, United States

Site Status RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status RECRUITING

Epic Medical Research - DeSoto

DeSoto, Texas, United States

Site Status RECRUITING

Sleep Therapy & Research Center

San Antonio, Texas, United States

Site Status RECRUITING

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status RECRUITING

Woolcock Institute of Medical Research

Macquarie Park, New South Wales, Australia

Site Status RECRUITING

Royal Brisbane and Womens Hospital

Herston, Queensland, Australia

Site Status RECRUITING

Aggarwal and Associates Ltd

Brampton, Ontario, Canada

Site Status RECRUITING

Wharton Medical Clinic

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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United States Australia Canada

Central Contacts

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Amgen Call Center

Role: CONTACT

866-572-6436

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20230225

Identifier Type: -

Identifier Source: org_study_id

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