drugset / Trial / NCT05606913

A Study of IBI362 in Participants With Type 2 Diabetes

NCT05606913 ↗

Phase 3 Completed 731 enrolled Innovent Biologics (Suzhou) Co. Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.

Timeline

Start
2023-01-06
Primary completion
2024-01-26
Completion
2024-04-09

Outcome

Met primary endpoint

paper Both doses of mazdutide showed non-inferiority and superiority to the 1.5-mg dose of dulaglutide PMID 41407860 ↗

paper with a least-squares mean treatment difference of -0.24% (P = 0.0032) for 4 mg mazdutide PMID 41407860 ↗

release “The results of another Phase 3 study DREAMS-2, involving patients with T2D inadequately controlled by oral antidiabetic drugs (OADs), met the study endpoints” innoventbio.com ↗

release “The primary endpoint was successfully met, showing a robust glucose-lowering efficacy of mazdutide” innoventbio.com ↗

release “Among these, GLORY-1, DREAMS-1, and DREAMS-2 have already met their primary endpoints” innoventbio.com ↗

release “DREAMS-2 has previously met the study endpoints” innoventbio.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dulaglutide Peptide 1.5 mg Subcutaneous
Subject Mazdutide Protein / enzyme biologic 4 mg Subcutaneous
Subject Mazdutide Protein / enzyme biologic 6 mg Subcutaneous