Actively Recruiting
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-06-29
260
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of IBI362 in subjects with moderate-to-severe obstructive sleep apnea (OSA) and a body mass index (BMI) ≥28 kg/m2. Subjects will be randomly assigned to IBI362 9 mg and placebo groups. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
CONDITIONS
Official Title
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent
- Polysomnography during screening shows apnea-hypopnea index (AHI) of 15 or more events per hour
- Body mass index (BMI) of 28.0 kg/m2 or higher at screening
- For PAP users: received PAP therapy for at least 3 consecutive months prior to screening and plan to continue during the study
- For non-PAP users: unable or unwilling to undergo PAP therapy and have not used PAP for at least 4 weeks prior to screening
You will not qualify if you...
- For PAP users: have responsibilities or situations making it unsafe to stop PAP therapy for 7 days prior to polysomnography testing
- For PAP users: unwilling to stop PAP therapy for 7 days prior to polysomnography testing
- Have type 1 or type 2 diabetes mellitus
- Previous or planned surgery for sleep apnea or major ear, nose, or throat surgery affecting breathing at baseline
- Significant craniofacial abnormalities affecting breathing at baseline
- Diagnosis of obesity hypoventilation syndrome or daytime hypercapnia
- Active device treatment of OSA other than PAP or other treatments interfering with study outcomes unless willing to stop during study
- Respiratory or neuromuscular diseases interfering with trial results
- Achieved more than 5% body weight change through diet and exercise alone for at least 12 weeks prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
Research Team
B
baiyi yan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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