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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Obesity, Obstructive Sleep Apnea

In brief

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.

Key facts

Study ID

NCT07225686

Run by

Amgen

People needed

250

Starts

2025-12-19

Expected to finish

2028-09-13

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peninsula Research Associates — Rolling Hills Estates, California, United States (enrolling)
• Teradan Clinical Trials — Brandon, Florida, United States (enrolling)
• Destiny Research Center — Palmetto Bay, Florida, United States (enrolling)
• Clinical Research Center Of Florida — Pompano Beach, Florida, United States (enrolling)
• NeuroTrials Research — Atlanta, Georgia, United States (enrolling)
• Basil Clinical — Laurelton, New York, United States (enrolling)
• Monroe Biomedical Research — Monroe, North Carolina, United States (enrolling)
• CTI Clinical Research Center — Cincinnati, Ohio, United States (enrolling)
• FutureSearch Trials of Neurology — Austin, Texas, United States (enrolling)
• Epic Medical Research - DeSoto — DeSoto, Texas, United States (enrolling)
• Sleep Therapy & Research Center — San Antonio, Texas, United States (enrolling)
• Northwest Clinical Research Center — Bellevue, Washington, United States (enrolling)
• Woolcock Institute of Medical Research — Macquarie Park, New South Wales, Australia (enrolling)
• Royal Brisbane and Womens Hospital — Herston, Queensland, Australia (enrolling)
• Monash Medical Centre — Clayton, Victoria, Australia (enrolling)
• Nucleo de Pesquisa do Rio Grande do Sul — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• Instituto de Pesquisa Clinica de Campinas - Ipecc — Campinas, São Paulo, Brazil (enrolling)
• CPQuali Pesquisa Clinica Ltda — São Paulo, São Paulo, Brazil (enrolling)
• Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo Hcfmusp — São Paulo, São Paulo, Brazil (enrolling)
• Centro Paulista de Investigacao Clinica Cepic — São Paulo, Brazil (enrolling)
• CaRe Clinic — Calgary, Alberta, Canada (enrolling)
• Aggarwal and Associates Ltd — Brampton, Ontario, Canada (enrolling)
• Wharton Medical Clinic — Hamilton, Ontario, Canada (enrolling)
• Diex Recherche Trois Rivieres — Trois-Rivières, Quebec, Canada (enrolling)
• Valley Clinical Trials — Northridge, California, United States (enrolling)

Full record on ClinicalTrials.gov

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