The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea
Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.
At screening visit, BMI 24-42kg/m2(both inclusive)
Self-reported Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG
Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;
Diabetes (except gestational diabetes)
There are diseases that may require systemic glucocorticoid therapy during the study period
Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of screening Visit .Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion.
Parallel
HRS9531 Injection
DrugTitration administration, SC
HRS9531 Injection
DrugTitration administration, SC
Placebo Injection
DrugSC
Percentage change from baseline in body weight
Change from Baseline in Apnea-Hypopnea Index (AHI)
Proportion of subjects with weight loss of ≥5% from baseline after 32 weeks of treatment
Proportion of subjects with weight loss of ≥10% from baseline after 32 weeks of treatment
Proportion of subjects with weight loss of ≥15%from baseline after 32 weeks of treatment
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
