A Study of IBI362 in Chinese Subjects With Obstructive Sleep Apnea and BMI≥28 kg/m2

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive, Obesity

In brief

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.

Key facts

Study ID

NCT06931028

Run by

Innovent Biologics (Suzhou) Co. Ltd.

People needed

260

Starts

2025-06-12

Expected to finish

2027-06-11

Last updated by the study team

2025-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking University Third Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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