drugset / Trial / NCT06931028

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

NCT06931028

Phase 3 Recruiting 260 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2025-06-12
Primary completion
2027-05-07
Completion
2027-06-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Mazdutide Protein / enzyme biologic 9 mg Subcutaneous