Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase III Study of IBI362 in Chinese Adults With Moderate-to-Severe Obstructive Sleep Apnea and BMI ≥28 kg/m2 (GLORY-OSA)
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2025-06-29
260
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of IBI362 in adults with moderate-to-severe obstructive sleep apnea (OSA) who have a body mass index (BMI) of 28 kg/m2 or higher. This Phase III study involves multiple centers and compares IBI362 to a placebo to better understand its impact on OSA symptoms and related health measures. Participants will be randomly assigned to receive either IBI362 or a placebo through weekly subcutaneous injections. The IBI362 dosage will increase gradually over the initial 12 weeks, starting from 2 mg once a week for 4 weeks, then 4 mg once a week for 4 weeks, followed by 6 mg once a week for 4 weeks, and finally 9 mg once a week for 36 weeks. The study includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week follow-up period after stopping the study drug. Throughout the trial, participants will undergo regular assessments including sleep studies to measure apnea-hypopnea index (AHI), body weight, blood pressure, and sleepiness scales. Researchers will monitor changes from baseline in these measures at Week 48. The safety and adherence to treatments will be closely tracked, and a final follow-up will occur 12 weeks after treatment ends. Total participation spans approximately 64 weeks.
CONDITIONS
Brief 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...
- Adults aged 18 years or older at the time of consent
- Moderate-to-severe obstructive sleep apnea with 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: Must have used positive airway pressure therapy for at least 3 consecutive months before screening and plan to continue during the study
- For non-PAP users: Unable or unwilling to use PAP therapy with no use for at least 4 weeks before screening
You will not qualify if you...
- For PAP users: Any personal or work responsibilities or other conditions that make stopping PAP therapy unsafe for 7 days before sleep testing during the study
- For PAP users: Unwillingness to stop PAP therapy for 7 days before sleep testing during the study
- Diagnosis of 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 high carbon dioxide levels
- Use of active OSA devices other than PAP therapy unless willing to stop during the study
- Respiratory or neuromuscular diseases that could affect trial results
- Achieved more than 5% body weight change through diet and exercise alone within 12 weeks before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive once-weekly subcutaneous injections of IBI362 with gradually increased doses or placebo for obstructive sleep apnea and elevated BMI.
Weekly visits for injections
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China, 100191
Actively Recruiting
Research Team
B
baiyi yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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