Actively Recruiting
A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2025-11-17
140
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects with Obstructive Sleep Apnea (OSA) and Obesity
CONDITIONS
Official Title
A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 to 75 years at consent
- Male or female participants
- Body mass index (BMI) of 28.0 kg/m² or higher at screening
- On controlled diet and exercise regimen for at least 3 months with weight change ≤ 5.0 kg in past 3 months
- Obstructive sleep apnea confirmed by polysomnography
- Female participants of childbearing potential and male participants with partners of childbearing potential agree to use effective contraception during the study period
- Female participants of childbearing potential must have a negative pregnancy test within 3 days before randomization and must not be breastfeeding
- Provided informed consent and able to comply with study requirements
You will not qualify if you...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels ≥ 3 times upper limit of normal, or total bilirubin ≥ 2 times upper limit of normal
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m²
- Thyroid-stimulating hormone (TSH) below 0.4 or above 6.0 mIU/L
- Clinically significant ECG abnormalities including severe arrhythmias or heart conditions
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
- Patient Health Questionnaire-9 (PHQ-9) score of 15 or higher
- Endocrine disorders or hereditary obesity syndromes affecting weight
- Diabetes mellitus
- Diagnosed central or mixed sleep apnea or Cheyne-Stokes respiration
- Respiratory or neuromuscular diseases interfering with trial results
- Insomnia or excessive sleepiness disorders unrelated to OSA
- Gastrointestinal conditions affecting motility or history of relevant surgeries
- History of pancreatitis, gallbladder disease, or related conditions
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Severe infections, trauma, or major surgery within 1 month prior to screening
- Severe cardiovascular or cerebrovascular events within 6 months prior to screening
- Malignancy within past 5 years (exceptions apply)
- Severe psychiatric disorders or history of substance abuse
- Severe liver or hematologic diseases
- Autoimmune diseases requiring systemic corticosteroids or immunosuppressants during study
- Use of medications causing significant weight changes within 3 months prior to screening
- Use of treatments affecting sleepiness assessments
- Prior or planned bariatric surgery (except liposuction >1 year ago)
- Prior or planned endoscopic or device-based weight loss treatments or device removal within 6 months
- Use of positive airway pressure or other OSA treatments unless discontinued 4 weeks prior and during study
- Requirement for supplemental oxygen
- Participation in other drug or device trials within 3 months prior to screening
- Recent blood donation or transfusion within 3 months
- Planned surgery during trial that may affect results
- Mental incapacity or language barriers impeding participation
- Conditions affecting safety or evaluation of trial results
- Investigators, staff, or immediate family members involved in the study
- Employees of Hengrui Company are excluded
AI-Screening
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Trial Site Locations
Total: 1 location
1
Beijing Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
Research Team
Y
Yadi Tang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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