NCT07487103

Efficacy and Safety of QLG1090 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-group, Active-controlled Clinical Trial to Evaluate Efficacy and Safety of QLG1091 Versus Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 478 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, double-blind, double-dummy, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 33 weeks including screening and follow-up.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	QLG1091	Oral administration once-daily.
DRUG	Rybelsus	Oral administration once-daily

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-12-01
• Completion: 2027-05-01
• First posted: 2026-03-23
• Last updated: 2026-03-23