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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
Asset
HRS9531
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
1
Enrollment
140
estimated
Study population
Obesity / overweight, Sleep apnea
Key I/E criterion
•BMI ≥28
Primary endpoint
•AHI, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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).
Endpoints (5)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointThe percent change in body weight from baseline after 52 weeks of treatment.
Time frame:52 weeks
Body weight, % change
percent change from baseline, improvement
Other clinical outcomes
4 endpointsThe change of AHI form baseline after 52 weeks of treatment
Time frame:52 weeks
AHI, change
change from baseline, improvement
The percentage change in AHI from baseline after 52 weeks of treatment
Time frame:52 weeks
AHI, change
percent change from baseline, improvement
The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;
Time frame:52 weeks
OSA responder
threshold achievement, improvement
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
OSA responder
threshold achievement, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.