NCT06931028RecruitingPhase 3
A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to Assess the Efficacy and Safety of IBI362 in Chinese Subjects With Moderate-to-Severe Obstructive Sleep Apnea and BMI≥28 kg/m2 (GLORY-OSA)
Source: ClinicalTrials.gov · Last updated 29 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (estimated)
- First submitted
- 9 Apr 2025
- Start date
- 12 Jun 2025
- Primary completion date
- 7 May 2027
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Diseases
- Obesity
- NCT number
- NCT06931028
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 260
- From 12 Jun 2025 to the primary completion date, 7 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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：
- 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
- 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.
- Have achieved a \>5% change in body weight through diet and exercise alone for at least 12 weeks prior to screening.
Other illness
- Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM).
- Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
- Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
Other
- For PAPs：
- Have significant craniofacial abnormalities that may affect breathing at baseline
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.