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

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Apr 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI362 for people with obstructive sleep apnea (OSA) who also have obesity (a body mass index, or BMI, of 28 kg/m² or higher). OSA is a condition that causes breathing interruptions during sleep, which can lead to daytime tiredness and other health issues. The trial will compare the effects of IBI362 to a placebo (a treatment that doesn't contain the active drug) to see if it is safe and effective. Participants will receive injections once a week for about a year, and the study will include a screening period, a treatment period, and a follow-up period after treatment ends.

To be eligible for the trial, participants must be at least 18 years old and have moderate to severe OSA, as shown by a sleep study. Some participants will need to have been using a specific breathing device called a positive airway pressure (PAP) machine for at least three months, while others who cannot use it must have not used it for at least four weeks before the study. It's important to know that the trial is not yet recruiting participants, and those who have certain medical conditions or have recently lost significant weight may not qualify. This study aims to find better treatment options for sleep apnea while maintaining participant safety throughout the process.

Gender

ALL

Eligibility criteria

• 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.