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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: 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 not on PAP therapy and are living with overweight or obesity.

Key facts

Study ID

NCT07226765

Run by

Amgen

People needed

250

Starts

2025-11-25

Expected to finish

2028-09-13

Last updated by the study team

2026-06-12

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• Individuals who have had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
• 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.

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)
• 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)
• Nemocnice Rudolfa a Stefanie Benesov as — Benesov U Prahy, Czechia (enrolling)
• Valley Clinical Trials — Northridge, California, United States (enrolling)

Full record on ClinicalTrials.gov

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