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

Launched by FUJIAN SHENGDI PHARMACEUTICAL CO., LTD. · May 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HRS-9531 injection for patients who have both obstructive sleep apnea (OSA) and obesity. OSA is a condition where a person has trouble breathing during sleep, and obesity can make this condition worse. Participants in the trial will be individuals aged 18 to 75 who have a body mass index (BMI) of 28 or higher and have been using a device called positive airway pressure (PAP) therapy for at least three months. They must also have a confirmed diagnosis of moderate to severe OSA.

If you qualify and choose to participate, you’ll receive either the HRS-9531 injection or a placebo (a harmless substance with no active medication), but neither you nor the researchers will know which one you’re receiving to ensure unbiased results. You’ll need to take a break from your PAP therapy for about a week before certain tests during the study. It’s important to note that some health conditions and past surgeries may make you ineligible for this trial. Participating in this study could help researchers understand if this new treatment can improve sleep and overall health for people facing these challenges.

Gender

ALL

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).