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Recruiting
NCT07225686
Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Conditions: Obesity, 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 receiving positive airway pressure (PAP) therapy and are living with overweight or obesity.
Eligibility Criteria
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 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.
Source: ClinicalTrials.gov (NCT07225686). StuddyBuddy aggregates publicly available trial information.