Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Conditions
Brief summary
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.
Interventions
DRUGHRS9531
HRS9531 will be administered by Subcutaneous injection
DRUGPlacebo
Matching Placebo will be administered by Subcutaneous injection
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 -75 (inclusive), male or female Sex 2. BMI ≥28.0 kg/m2； 3. ≥3 months of diet/exercise control pre-screening with ≤5.0 kg weight fluctuation in prior 3 months. 4. Confirmed OSA diagnosis with screening PSG showing AHI ≥15.0 events/h. 5. ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG. 6. Females/males of childbearing potential must use highly effective contraception from consent until 2 months post-treatment, with no pregnancy/donation plans. Females require negative pregnancy test ≤3 days pre-randomization and non-lactating.
Exclusion criteria
1. Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes excluded. 2. Diabetes mellitus (excluding gestational diabetes). 3. Prior/planned OSA-related major surgeries (e.g., tonsillectomy/adenoidectomy) that may affect breathing. 4. Have significant craniofacial abnormalities that may affect breathing at baseline 5. Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration 6. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator. 7. Impaired gastric emptying (e.g., gastric bypass, pyloric stenosis)；Chronic use of GI motility-affecting drugs；Severe GI disorders (e.g., active PUD, IBD)；GI surgeries (except non-motility-affecting procedures) 8. Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury)；Acute cholecystitis history；Symptomatic/treated gallbladder disease 9. Have used drugs or treatments that may cause significant weight gain or loss within 3 months 10. Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of AHI form baseline after 52 weeks of treatment | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The percentage change in AHI from baseline after 52 weeks of treatment | 52 weeks |
| The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment; | 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; | 52 weeks |
| The percent change in body weight from baseline after 52 weeks of treatment. | 52 weeks |
Countries
China
Contacts
CONTACTSiai Sun
Outcome results
None listed