Maridebart Cafraglutide versus Placebo in Adult Participants with Obstructive Sleep Apnea not on Positive Airway Pressure (PAP) TherapyMARITIME-OSA-2
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 not on 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
Percent 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
Percent 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
Percent Change in High Sensitivity C-reactive Protein (hs-CRP) from baseline at Week 52
Timeframe: At Week 52
Change in Systolic Blood Pressure (SBP) 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
Percent 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-related Impairment 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 in Patient Global Impression of Severity (PGI-S) Sleep-Related Impairment, Sleep Quality, Sleepiness from Baseline at Week 52
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 in Fasting Insulin From Baseline at Week 52
Timeframe: At Week 52
Change in Fasting Plasma Glucose (FPG) (mg/dL, mmol/L) From Baseline at Week 52
Timeframe: At Week 52
Change in Hemoglobin A1c 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 Week 100
Plasma Concentration of Maridebart Cafraglutide at Week 52
Timeframe: At Week 52