Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAmgen
About this trial
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
Qualifiers
AHI ≥ 15 on polysomnography at day 1 before randomization.
BMI ≥ 27 kg/m² 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.
Disqualifiers
Had any previous or planned upper airway surgery for sleep apnea or major ear, nose, or throat surgery.
Significant craniofacial abnormalities that may affect breathing at screening.
Diagnosis of Central Apnea with % of central apneas/hypopneas ≥ 50%, and/or diagnosis of Cheyne Stokes Respiration.
Active device treatment of obstructive sleep apnea other than PAP therapy (eg, oral appliances), or other treatments, that in the opinion of the investigator, may interfere with trial outcomes, unless willing to stop treatment at screening and throughout the trial.
Trial design
Treatments tested in this trial
- Maridebart cafraglutide
- Placebo
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov