NCT06994650 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
| NCT ID | NCT06994650 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 140 participants in total. It began in 2025-08-13 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06994650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06994650 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 140 participants.
Is NCT06994650 currently recruiting?
Yes, NCT06994650 is actively recruiting participants. Contact the research team at siai.sun@hengrui.com for enrollment information.
Where is the NCT06994650 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06994650 clinical trial?
NCT06994650 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 140 participants.
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