A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity
The participant has provided informed consent and is willing and able to comply with the study protocol requirements to complete the study.
Age between 18 and 75 years, male or female, at the time of signing the informed consent form.
BMI ≥ 28.0 kg/m² at screening.
Has been on a controlled diet and exercise regimen for 3 months or more, with a weight change of ≤ 5.0 kg in the past 3 months.
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × upper limit of normal (ULN), or total bilirubin (TBIL) ≥ 2.0 × ULN.
Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula based on serum creatinine).
Thyroid-stimulating hormone (TSH) < 0.4 or > 6.0 mIU/L.
Other laboratory abnormalities judged by the investigator to potentially affect efficacy or safety assessments.
Parallel
HRS9531
DrugHRS9531
HRS9531placebo
DrugHRS9531placebo
Percentage Change in AHI from Baseline at Week 52 of Treatment
Changes in AHI Relative to Baseline After 52 Weeks of Treatment
Proportion of Subjects with AHI <5.0 events/h, or AHI 5.0-14.0 events/h with Epworth Sleepiness Scale (ESS) ≤10 at Week 52 of Treatment
Percentage Change in Body Weight from Baseline at Week 52 of Treatment
Change in Epworth Sleepiness Scale (ESS) Score from Baseline at Week 52 of Treatment
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