Status:
RECRUITING
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
Lead Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Conditions:
Sleep Apnea
Obstructive
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 (...
Eligibility Criteria
Inclusion
- For PAP s: Subjects who have received positive airway pressure (PAP) therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study.
- For non-PAP s:Subjects who are unable or unwilling to undergo PAP therapy. PAP must not have been used for at least 4 weeks prior to screening.
- For all subjects:
- Age ≥18 years at the time of signing informed consent.
- Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour.
- Body mass index (BMI) ≥28.0 kg/m² at screening.
Exclusion
- For PAPs：
- Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study
- Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study For all subjects：
- Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).
- Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
- Have significant craniofacial abnormalities that may affect breathing at baseline
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
- Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
- Have achieved a \>5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening.
Key Trial Info
Start Date :
June 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 11 2027
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT06931028
Start Date
June 12 2025
End Date
June 11 2027
Last Update
June 29 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, China, 100191