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

Launched by GAN & LEE PHARMACEUTICALS. · Jan 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new injection called GZR18 to see how well it works and how safe it is for adults with Type 2 Diabetes Mellitus (T2DM) who are having trouble controlling their blood sugar levels. The trial will focus on individuals who have been diagnosed with diabetes for at least 12 weeks and are currently taking metformin, either alone or with other diabetes medications. To qualify for the study, participants should have a specific range of blood sugar levels and have been on a stable dose of their diabetes medication for a while.

If you or a loved one is interested in participating, you should be aware that the trial is not yet recruiting, meaning they haven't started signing up participants yet. Those eligible will be between the ages of 65 to 74 and will undergo screenings to ensure they meet the necessary health criteria. Participants can expect regular check-ups and monitoring during the study to assess how well the medication is working and to ensure their safety. It’s important to note that individuals with certain serious health conditions, such as severe complications from diabetes or specific heart and kidney issues, will not be eligible to join the trial.

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Eligibility criteria

• 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.