Status:
NOT_YET_RECRUITING
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Lead Sponsor:
Fujian Shengdi Pharmaceutical Co., Ltd.
Conditions:
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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 ventil...
Eligibility Criteria
Inclusion
- 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.
- ≥3 months of PAP therapy pre-screening with planned continuation; willingness to pause PAP ≥1 week before each PSG.
- 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
- 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
- Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas ≥50%, or diagnosis of Cheyne Stokes Respiration
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- 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)
- Pancreatic disorders (acute/chronic pancreatitis, pancreatic injury)；Acute cholecystitis history；Symptomatic/treated gallbladder disease
- Have used drugs or treatments that may cause significant weight gain or loss within 3 months
- Investigator-determined unsuitability/unwillingness to pause PAP therapy for at least 1 week pre-PSG (e.g., safety/occupational/personal considerations).
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06994650
Start Date
June 1 2025
End Date
January 1 2027
Last Update
May 29 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044