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

Phase 3

Not yet recruiting

• Conditions: Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
• Interventions: Drug: HRS9531; Drug: Placebo

• Registration Number: NCT06994650
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-20
• Study First Posted: 2025-05-29
• Last Update Posted: 2025-05-29
• Study Start: 2025-06
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS9531	HRS9531	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
The change of AHI form baseline after 52 weeks of treatment	52 weeks

Secondary Outcome Measures

Name	Time	Method
The percentage change in AHI from baseline after 52 weeks of treatment	52 weeks
The percentage of subjects with ≥50% AHI reduction from baseline after 52 weeks of treatment;	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;	52 weeks
The percent change in body weight from baseline after 52 weeks of treatment.	52 weeks

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China