drugset / Trial / NCT06184568

A Study Comparing IBI362 vs Semaglutide in Chinese Adults With Early Type 2 Diabetes and Obesity

NCT06184568

Phase 3 Completed 349 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter, randomized, Open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 6 mg OW versus Semalgutide 1 mg OW in obese(BMI≥28kg/m2) early T2D subjects. Subjects will be randomly assigned to IBI362 6 mg and Semalgutide 1 mg groups for 32 weeks (active-controlled treatment period). In the extension period, participants originally on mazdutide were assigned to continue for an additional 24 weeks with mazdutide 9 mg or 6 mg based on whether they achieved the weight-loss target. All study treatment will be administered once-weekly and subcutaneously. The entire trial cycle includes a 2-week screening period, a 32-week active-controlled treatment period, a 24 week extension period and a 4-week drug withdrawal safety follow-up period.

Timeline

Start
2024-02-29
Primary completion
2025-09-17
Completion
2026-02-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Mazdutide Protein / enzyme biologic 6 mg Subcutaneous
Comparator Semaglutide Peptide 1 mg Subcutaneous