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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
HRS9531 will be administered by Subcutaneous injection
Matching Placebo will be administered by Subcutaneous injection
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe change of AHI form baseline after 52 weeks of treatment
Time frame: 52 weeks
The percentage change in AHI from baseline after 52 weeks of treatment
Time frame: 52 weeks
The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;
Time frame: 52 weeks
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;
Time frame: 52 weeks
The percent change in body weight from baseline after 52 weeks of treatment.
Time frame: 52 weeks
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