Actively Recruiting
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
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-01-26
140
Participants Needed
1
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, male or female
- Body mass index (BMI) of 28.0 kg/m2 or higher
- At least 3 months of diet and exercise control before screening with weight fluctuation within 5.0 kg in prior 3 months
- Confirmed obstructive sleep apnea diagnosis with apnea-hypopnea index (AHI) of 15.0 events/h or higher by screening polysomnography
- At least 3 months of positive airway pressure (PAP) therapy before screening with planned continuation; willingness to pause PAP therapy for at least 1 week before each polysomnography
- Females and males of childbearing potential must use highly effective contraception from consent until 2 months after treatment, with no pregnancy or donation plans; females must have a negative pregnancy test within 3 days before randomization and must not be breastfeeding
You will not qualify if you...
- Endocrine disorders significantly affecting weight (e.g., Cushing's syndrome, hypo-/hyperthyroidism) or monogenic/hereditary obesity syndromes
- Diabetes mellitus (excluding gestational diabetes)
- Prior or planned major surgeries related to obstructive sleep apnea (e.g., tonsillectomy or adenoidectomy) that may affect breathing
- Significant craniofacial abnormalities affecting breathing at baseline
- Diagnosis of central or mixed sleep apnea with 50% or more mixed or central apneas/hypopneas, or diagnosis of Cheyne Stokes respiration
- Respiratory and neuromuscular diseases that could interfere with trial results as judged by the investigator
- Impaired gastric emptying (e.g., gastric bypass, pyloric stenosis), chronic use of gastrointestinal motility-affecting drugs, severe gastrointestinal disorders (e.g., active peptic ulcer disease, inflammatory bowel disease), or gastrointestinal surgeries except non-motility-affecting procedures
- Pancreatic disorders (acute or chronic pancreatitis, pancreatic injury), history of acute cholecystitis, symptomatic or treated gallbladder disease
- Use of drugs or treatments causing significant weight changes within 3 months
- Investigator-determined unsuitability or unwillingness to pause PAP therapy for at least 1 week before polysomnography (e.g., for safety, occupational, or personal reasons)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
S
Siai Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here