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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
Participants will receive maridebart cafraglutide as SC injections.
Participants will receive placebo SC.
Change in AHI from baseline at week 52
Time frame: At Week 52
Percentage Change in AHI from baseline at week 52
Time frame: At Week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at week 52
Time frame: At Week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52
Time frame: At Week 52
Percentage Change in Body Weight from baseline at Week 52
Time frame: At Week 52
Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at Week 52
Time frame: At Week 52
Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52
Time frame: At Week 52
Change in Systolic Blood Pressure from baseline at Week 48
Time frame: 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
Time frame: At Week 52
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