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

NCT07487103 · Not yet recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and effectiveness of the experimental drug QLG1091 compared to Rybelsus in adults with type 2 diabetes who are already taking metformin.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, open-label (no blinding) treatment study

Participants 478 people Planned (estimated).

Who can join Ages 18–75 · all sexes

Timeline Started 2026-05 · est. completion 2027-05

What this study is testing ClinicalTrials.gov NCT07487103 ↗

Description as written by the study sponsor.

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.

Treatments tested

QLG1091 Drug

Oral administration once-daily.
Rybelsus Drug

Oral administration once-daily

Main thing measured	Change in HbA1c
Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions studied	Type 2 Diabetes
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07487103 ↗