drugset / Trial / NCT07487103

Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

NCT07487103

Phase 3 Not yet recruiting 478 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is to evaluate the efficacy and safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes. The primary objective is to demonstrate equivalence of QLG1091 and Rybelsus. This study is a randomized, open-label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.

Timeline

Start
2026-05-01
Primary completion
2026-12
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject QLG1091 Unknown Oral
Comparator Semaglutide Peptide Oral