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

NCT ID: NCT06553248

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-22
• Study Completion Date: 2023-11-01

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

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GZR4

s.c., once weekly

Group Type: EXPERIMENTAL

GZR4

Intervention Type: DRUG

Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks

Insulin Degludec

s.c., once daily

Group Type: ACTIVE_COMPARATOR

Insulin Degludec

Intervention Type: DRUG

Administered once daily subcutaneously (s.c., under the skin) for 6 weeks

Interventions

GZR4

Administered once weekly subcutaneously (s.c., under the skin) for 6 weeks

Intervention Type: DRUG

Insulin Degludec

Administered once daily subcutaneously (s.c., under the skin) for 6 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gan and Lee Pharmaceuticals, USA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

GL-GZR-CH1016

Identifier Type: -

Identifier Source: org_study_id