IBI362 for Chinese adults with obstructive sleep apnea and BMI ≥28

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase III study enrolling adults with moderate-to-severe obstructive sleep apnea (AHI ≥15) and BMI ≥28 kg/m2. After a 4-week screening period including polysomnography, participants will be randomized to receive once-weekly subcutaneous IBI362 9 mg or placebo for 48 weeks, followed by a 12-week drug-withdrawal follow-up. The protocol includes participants who use positive airway pressure (PAP) therapy and those who do not, with PSG-based eligibility and on-study sleep assessments. Safety and efficacy outcomes will be compared between the IBI362 and placebo groups over the treatment and follow-up periods.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Third Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: baiyi yan
• Email: baiyi.yan@innoventbio.com
• Phone: 0512-69566088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.