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NCT Number: NCT07487103

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

QLG1091

Drug

Oral administration once-daily.

Rybelsus

Drug

Oral administration once-daily

Primary outcomes

  1. Change in HbA1c

    Time frame: Week 26

    Change from baseline in HbA1c was evaluated at Week 26

Study contacts

Contact information is provided by the study sponsor or research team.

Fangyi Wang, Bachelor

CONTACT

[email protected]

+86-18266419923

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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