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

Starting soon · Phase 3

Conditions studied: Type 2 Diabetes

In brief

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.

Key facts

Study ID

NCT07487103

Run by

Qilu Pharmaceutical Co., Ltd.

People needed

478

Starts

2026-05-01

Expected to finish

2027-05-01

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Female or male，age 18 to 75.
• Body mass index (BMI) ≥ 22 kg/m² and ≤ 35 kg/m² at screening.
• HbA1c of 7.0-10.5 %.
• Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening.
• Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose≥1000 mg/day) at least 90 days prior to the day of screening.

You may not qualify if…

• Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
• History of pancreatitis (acute or chronic).
• History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
• Subjects presently classified as being in New York Heart Association Class IV.
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
• Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\\\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI).

Full record on ClinicalTrials.gov

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