A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of GZR4 in Chinese Patients With Type 2 Diabetes Mellitus

This trial is conducted in China. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of mutiple-dose GZR4 in subjects with type 2 diabetes

Inclusion Criteria:

• Male or female at the age of 18-65 (inclusive) at the time of informed consent
• Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) at screening
• Diagnosis of type 2 diabetes mellitus for over 3 months
• Hemoglobin A1c (HbA1c) ≥ 6.5% and ≤ 10.0% at screening.

Exclusion Criteria:

• History of drug abuse within 1 year before screening, or positive drug abuse screening results during the screening period or at baseline
• Malignancy or increased risk of malignancy before screening: any suspected and/or diagnosed malignancy or documented history of malignancy
• Confirmed or suspected type 1 diabetes mellitus, gestational diabetes mellitus, or specific types of diabetes mellitus from other causes (monogenic diabetes syndrome, cystic fibrosis, pancreatitis, drug-induced or chemically induced diabetes mellitus, etc.) prior to screening
• Presence of the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma; proliferative retinopathy or maculopathy that is unstable or requiring treatment; symptomatic diabetic neuropathy, intermittent claudication or diabetic foot
• Severe hypoglycaemic events (Level 3 hypoglycaemia) within 6 months prior to screening, or 3 or more hypoglycaemic events (blood glucose ≤ 3.9 mmol/L) within 1 month prior to screening, or recurrent hypoglycaemia-related symptoms