Status:
COMPLETED
A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Diabetes
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Diabetes
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06553248
Start Date
March 22 2023
End Date
November 1 2023
Last Update
August 14 2024
Active Locations (1)
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1
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, China, 100000