This study is a phase 3 clinical trial, aiming to evaluate the efficacy and safety of HRS-9531 injection in obese subjects with obstructive sleep apnea (OSA) who are on positive airway pressure ventilation (PAP) therapy.
Aged 18 -75 (inclusive), male or female Sex
BMI ≥28.0 kg/m2；
≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months.
Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h.
Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded.
Diabetes mellitus (excluding gestational diabetes).
Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing.
Have significant craniofacial abnormalities that may affect breathing at baseline
Parallel
HRS9531
DrugHRS9531 will be administered by Subcutaneous injection
Placebo
DrugMatching Placebo will be administered by Subcutaneous injection
The change of AHI form baseline after 52 weeks of treatment
The percentage change in AHI from baseline after 52 weeks of treatment
The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;
The percentage of subjects with AHI <5.0 events /h, or AHI ranging from 5.0 to 14.0 events/h and Epworth Sleepiness Scale (ESS) ≤10 after 52 weeks of treatment;
The percent change in body weight from baseline after 52 weeks of treatment.
Click on the lead sponsor to view all of their trials.
