HRS9531 injection for obese adults with moderate-to-severe obstructive sleep apnea who use PAP

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

This trial will test whether HRS9531 injections can reduce sleep apnea events and improve symptoms in adults with obesity and moderate-to-severe OSA who are already using PAP therapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06994650 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 trial comparing HRS9531 injection with placebo in adults aged 18–75 who have obesity and moderate-to-severe obstructive sleep apnea while on PAP therapy. Participants must have been on PAP for at least three months and will continue PAP overall but may pause it briefly before study sleep tests. Outcomes will include changes in sleep apnea metrics measured by polysomnography and monitoring of safety and adverse events during the treatment period. The multicenter design aims to confirm efficacy and safety seen in earlier development before potential regulatory decisions.

Who should consider this trial

Good fit: Adults 18–75 with BMI ≥28 kg/m2, confirmed moderate-to-severe OSA (AHI ≥15 events/hour), on PAP therapy for ≥3 months, and willing to follow study visit and PSG requirements are the ideal candidates.

Not a fit: People with diabetes, major endocrine causes of weight change, planned or recent major OSA surgery, pregnant or breastfeeding women, or those unwilling to comply with PAP and PSG requirements are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, HRS9531 could lower apnea-hypopnea events and symptoms, offering an additional treatment option for obese patients already using PAP.

How similar studies have performed: Pharmacologic approaches to OSA have shown modest or mixed results historically, and earlier-phase work for agents like HRS9531 suggested signals that now require confirmation in this larger Phase 3 setting.

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).

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Siai Sun

Conditions Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy