Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure TherapyMARITIME-OSA-1
Study Details
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.
Protocol Summary
Change in Apnea-Hypopnea Index (AHI) from baseline at week 52
Timeframe: At week 52
Percentage Change in AHI from baseline at week 52
Timeframe: At week 52
Participants Achieving ≥ 50% AHI Reduction from baseline at week 52
Timeframe: At week 52
Participants Achieving AHI < 5 or AHI 5 to 14 with Epworth Sleepiness Scale (ESS) ≤ 10 from baseline at week 52
Timeframe: At week 52
Percentage Change in Body Weight from baseline at week 52
Timeframe: At week 52
Change in Sleep Apnea-specific Hypoxic Burden (SASHB) from baseline at week 52
Timeframe: At week 52
Percentage change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at week 52
Timeframe: At week 52
Change in Systolic Blood Pressure from baseline at week 48
Timeframe: 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
Timeframe: At week 52
Change in AHI from baseline at week 24
Timeframe: At week 24
Percentage change in AHI from baseline at week 24
Timeframe: At week 24
Change in SASHB from baseline at week 24
Timeframe: At week 24
Change in ESS score from baseline at week 52
Timeframe: At week 52
Change in PROMIS Short Form v1.0 Sleep Disturbance 8b score from baseline at week 52
Timeframe: At week 52
Change in Short Form-36 Health Survey Version 2 (SF-36v2) Acute domain and summary scores from baseline at week 52
Timeframe: At week 52
Change from baseline at week 52 in Patient Global Impression of Severity (PGI-S) Sleep-related impairment, Sleep quality, and Sleepiness.
Timeframe: At week 52
Percentage of participants achieving ≥ 10% reduction in body weight from baseline at week 52
Timeframe: At week 52
Percentage of participants achieving ≥ 15% reduction in body weight from baseline at week 52
Timeframe: At week 52
Percentage of participants achieving ≥ 20% reduction in body weight from baseline at week 52
Timeframe: At week 52
Change in waist circumference from baseline at week 52
Timeframe: At week 52
Change in waist-to-height ratio from baseline at week 52
Timeframe: At week 52
Change in neck circumference from baseline at week 52
Timeframe: At week 52
Percentage change in Total Cholesterol, High-density lipoprotein cholesterol (HDL-C), Non-HDL-C, Low-density lipoprotein cholesterol (LDL-C), and Triglycerides from baseline at week 52 in fasting conditions
Timeframe: At week 52
Percent change from baseline at week 52 in fasting insulin
Timeframe: At week 52
Change from baseline at week 52 in fasting plasma glucose (FPG) (mg/dL, mmol/L)
Timeframe: At week 52
Change in hemoglobin A1c (HbA1c) (%, mmol/mol) from baseline at week 52
Timeframe: At week 52
Change in Diastolic Blood Pressure (DBP) from baseline at week 48
Timeframe: At week 48
Number of participants with Treatment-Emergent Adverse Events and Serious Adverse Events
Timeframe: Up to 100 weeks
Plasma concentration of maridebart cafraglutide at week 52
Timeframe: At week 52