Phase III Study of IBI362 Treatment for Chinese Adults With Moderate-to-Severe Obstructive Sleep Apnea and BMI of 28 kgm2 or Higher

What this Trial Is About

Researchers are evaluating the safety and effectiveness of IBI362 in adults with moderate-to-severe obstructive sleep apnea OSA who have a body mass index BMI of 28 kgm2 or higher. This Phase III study involves multiple centers and compares IBI362 to a placebo to better understand its impact on OSA symptoms and related health measures. Participants will be randomly assigned to receive either IBI362 or a placebo through weekly subcutaneous injections. The IBI362 dosage will increase gradually over the initial 12 weeks, starting from 2 mg once a week for 4 weeks, then 4 mg once a week for 4 weeks, followed by 6 mg once a week for 4 weeks, and finally 9 mg once a week for 36 weeks. The study includes a 4-week screening period, a 48-week double-blind treatment period, and a 12-week follow-up period after stopping the study drug. Throughout the trial, participants will undergo regular assessments including sleep studies to measure apnea-hypopnea index AHI, body weight, blood pressure, and sleepiness scales. Researchers will monitor changes from baseline in these measures at Week 48. The safety and adherence to treatments will be closely tracked, and a final follow-up will occur 12 weeks after treatment ends. Total participation spans approximately 64 weeks.

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