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

Phase 1

Completed

• Conditions: Diabetes
• Interventions: Drug: GZR4; Drug: Insulin Degludec

• Registration Number: NCT06553248
• Lead Sponsor: Gan and Lee Pharmaceuticals, USA

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-22
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-07
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GZR4	GZR4	s.c., once weekly
Insulin Degludec	Insulin Degludec	s.c., once daily

Primary Outcome Measures

Name	Time	Method
Incidence of TEAE	Baseline to Week 6

Secondary Outcome Measures

Name	Time	Method
AUC0-inf	Week 6
AUC0-168h	Week 1, Week 6
ADA of GZR4	Baseline to Week 10
AUC0-last	Week 6
Tmax,GZR4	Week 1, Week 6

Trial Locations

Locations (1)

Gan & Lee Pharmaceuticals Co., Ltd; 🇨🇳 Beijing, Beijing, China