NCT07226765 Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
| NCT ID | NCT07226765 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Amgen |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-11-25 |
| Primary Completion | 2027-09-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2025-11-25 with a primary completion date of 2027-09-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT07226765 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07226765 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT07226765 currently recruiting?
Yes, NCT07226765 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT07226765 trial being conducted?
This trial is being conducted at Northridge, United States, Rolling Hills Estates, United States, Brandon, United States, Palmetto Bay, United States and 11 additional locations.
Who is sponsoring the NCT07226765 clinical trial?
NCT07226765 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 250 participants.