drugset / Trial / NCT07677891

Phase II Study of Switching From Dulaglutide to PG-102(MG12) in Type 2 Diabetes Mellitus

NCT07677891

Phase 2 Not yet recruiting 60 enrolled ProGen. Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, open-label, multi-center, active-controlled Phase 2 clinical trial to evaluate the efficacy and safety of switching from once-weekly dulaglutide to PG-102(MG12) in patients with type 2 diabetes mellitus receiving stable dulaglutide therapy. The treatment period is 32 weeks, with an additional 4-week safety follow-up. The primary endpoint is the change in HbA1c(%) from baseline at Week 32.

Timeline

Start
2026-10
Primary completion
2027-05
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dulaglutide Peptide Subcutaneous
Subject PG-102(MG12) Protein / enzyme biologic 60 mg Subcutaneous
Subject PG-102(MG12) Protein / enzyme biologic 90 mg Subcutaneous