A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2
- Status
- RecruitingResults none
- Why it is watched
- non-weight indication: sleep
- Who it enrolls
- age 18 Years to no upper limit; excludes diabetes; BMI ≥28 required; conditions: Sleep Apnea; Obstructive; Obesity
- Interventions
- placebo; IBI362
- Conditions
- Sleep Apnea; Obstructive; Obesity
- Phase and size
- Phase 3 · 260 participants
- Dates
- Start 2025-06-12
Primary completion 2027-05-07 - Sponsor
- Innovent Biologics (Suzhou) Co. Ltd. (Industry)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Change from Baseline in Apnea-Hypopnea Index (AHI)Week 48
02Eligibility
Who can take part
Inclusion Criteria: * 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: 1. Age ≥18 years at the time of signing informed consent. 2. Polysomnography (PSG) during screening shows an apnea-hypopnea index (AHI) ≥15 events/hour. 3. Body mass index (BMI) ≥28.0 kg/m² at screening. Exclusion Criteria: 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.
03Change log
Registry changes
No changes recorded since the trial was added.