Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea Not on Positive Airway Pressure (PAP) Therapy
Not Applicable
Not yet recruiting
- Conditions
- Obstructive Sleep Apnea
- Interventions
- Drug: Placebo
- Registration Number
- NCT07226765
- Lead Sponsor
- Amgen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 250
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maridebart Cafraglutide Maridebart cafraglutide Participants will receive maridebart cafraglutide subcutaneously (SC). Placebo Placebo Participants will receive placebo SC.
- Primary Outcome Measures
Name Time Method Change in Apnea-hypopnea Index (AHI) from baseline at Week 52 At Week 52
- Secondary Outcome Measures
Name Time Method Percent Change in AHI from baseline at Week 52 At Week 52 Participants Achieving ≥ 50% AHI Reduction from baseline at Week 52 At Week 52 Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at Week 52 At Week 52 Percent Change in Body Weight from baseline at Week 52 At Week 52 Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52 At Week 52 Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52 At Week 52 Change in Systolic Blood Pressure (SBP) from baseline at Week 48 At Week 48 Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 Sleep-related Impairment 8a Score from baseline at Week 52 At Week 52