A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 3

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

1133 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
• Antidiabetic drugs that meet any of the following within 8 weeks before screening:

• A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ;

• A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors;

• A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose \< 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas.
• HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory).
• BG \< 15 mmol/L at screening (central laboratory).

Exclusion Criteria:

• Type 1 diabetes mellitus or special type of diabetes mellitus.
• Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization.
• Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.
• History of acute or chronic pancreatitis and pancreatic injury before screening.
• History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
• Any laboratory test indicator meeting the following criteria at screening or before randomization:
• Calcitonin level ≥ 50 ng/L (pg/mL) at screening.
• ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN.
• Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3).
• Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL.
• Blood amylase or lipase \> 1.5 × ULN.
• Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

Study team and timeline

Lead sponsor

Gan & Lee Pharmaceuticals.

Study start

Feb 13, 2025 Actual

Primary completion

Sep 18, 2026 Actual

Study completion

Sep 18, 2026 Actual

First posted

Jan 16, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.