Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP TherapyPhase 3NCT06994650
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
A Phase 3 study testing HRS9531 in people with Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
- What is being tested?
- HRS9531
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 13 Aug 2025to Jan 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Fang Han
About this study
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.
- Being tested
- HRS9531, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS9531Drug
HRS9531 will be administered by Subcutaneous injection
PlaceboDrug
Matching Placebo will be administered by Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| HRS9531 | Experimental | Not described Receives: Drug: HRS9531 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of AHI form baseline after 52 weeks of treatment
Measured: 52 weeks
Secondary outcomes (4)
The percentage change in AHI from baseline after 52 weeks of treatment
Measured: 52 weeks
The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;
Measured: 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;
Measured: 52 weeks
The percent change in body weight from baseline after 52 weeks of treatment.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start13 Aug 2025
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994650
- Sponsor's protocol ID
- HRS9531-307
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided