drugset / Trial / NCT06164873

A Study of IBI362 9 mg in Chinese Adults With Obesity

NCT06164873 ↗

Phase 3 Active not recruiting 462 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical study evaluating the efficacy and safety of IBI362 9 mg in obese subjects. 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 2-week screening period, a 60-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.

Timeline

Start
2023-12-27
Primary completion
2025-06-27
Completion
2025-09-19

Outcome

Met primary endpoint

paper mean percentage change in body weight from baseline was -16.65% (95% CI, -18.19% to -15.12%) in the mazdutide group compared with -1.50% (95% CI, PMID 42251595 ↗

paper between-group difference, -15.15% [95% CI, -17.22% to -13.09%]; P < .001). PMID 42251595 ↗

paper 84.3% of participants in the mazdutide group had a body weight reduction of 5% or greater compared with 33.1% in the placebo group PMID 42251595 ↗

release “in Chinese adults with obesity (GLORY-2) met the primary endpoints and all key secondary endpoints.” innoventbio.com ↗

release “In November 2025, the Phase 3 GLORY-2 study of mazdutide 9 mg met its primary endpoint and all key secondary endpoints” innoventbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Mazdutide Protein / enzyme biologic 9 mg Subcutaneous

Indications