Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
NCT ID: NCT07226765
Last Updated: 2026-02-05
Study Results
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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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2025-11-25
2028-09-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Maridebart Cafraglutide
Participants will receive maridebart cafraglutide subcutaneously (SC).
Maridebart cafraglutide
Participants will receive maridebart cafraglutide SC.
Placebo
Participants will receive placebo SC.
Placebo
Participants will receive placebo SC.
Interventions
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Maridebart cafraglutide
Participants will receive maridebart cafraglutide SC.
Placebo
Participants will receive placebo SC.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Those with significant craniofacial abnormalities that may affect breathing at screening.
* Participants diagnosed with Central Apnea with a percentage of central apneas/hypopneas of 50% or more, or those diagnosed with Cheyne Stokes Respiration.
* Active device treatment of OSA (eg, PAP, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at screening and throughout the study.
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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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
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
Northwest Clinical Research Center
Bellevue, Washington, United States
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia
Royal Brisbane and Womens Hospital
Herston, Queensland, Australia
Aggarwal and Associates Ltd
Brampton, Ontario, Canada
Wharton Medical Clinic
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20250002
Identifier Type: -
Identifier Source: org_study_id
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