NCT07487103Not yet recruitingPhase 3
Efficacy and Safety of QLG1091 vs Rybelsus as add-on to Metformin in Subjects With Type 2 Diabetes
A Multicenter, Randomized, Open-label, 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
Source: ClinicalTrials.gov · Last updated 28 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 478 (estimated)
- First submitted
- 17 Mar 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07487103
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 478
- From 1 May 2026 to the primary completion date, 31 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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).
Other
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.