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Recruiting
NCT07226765
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Conditions: Obstructive Sleep Apnea
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 250
Sponsor: Amgen
Location: Valley Clinical Trials Northridge California
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 not on PAP therapy and are living with overweight or obesity.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Individuals who have had any previous or planned upper airway surgery or major ear, nose or throat surgery for OSA.
* Those with significant craniofacial abnormalities that may affect breathing at screening.
* Participants diagnosed with 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 or other treatments, that in the opinion of the investigator, may interfere with study outcomes.
* 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.
Source: ClinicalTrials.gov (NCT07226765). StuddyBuddy aggregates publicly available trial information.