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RecruitingPhase 3

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

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

NCT IDNCT06994650
Org study IDHRS9531-307

Timeline

Milestones

Study first posted2025-05-29actual
Study start2025-08-13actual
Last update posted2026-01-26actual
Primary completion2026-12estimated (month precision)
Study completion2027-01estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightSleep apnea

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

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

Other clinical outcomes
4
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

The 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 endpoints
Primary/protocol endpoint

The change of AHI form baseline after 52 weeks of treatment

Time frame:52 weeks

AHI, change

change from baseline, improvement

Secondary/protocol endpoint

The percentage change in AHI from baseline after 52 weeks of treatment

Time frame:52 weeks

AHI, change

percent change from baseline, improvement

Secondary/protocol endpoint

The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;

Time frame:52 weeks

OSA responder

threshold achievement, improvement

Secondary/protocol endpoint

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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.