Not Yet RecruitingPhase 3

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

478 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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).

What they're measuring

Change in HbA1c

Timeframe: Week 26

Trial details

NCT IDNCT07487103

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Fangyi Wang, Bachelor

+86-18266419923 fangyi.wang@qilu-pharma.com

View on ClinicalTrials.gov More Type 2 Diabetes trials