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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06553248

Enrollment

Registered

2024-08-14

Start date

2023-03-22

Completion date

2023-11-01

Last updated

2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

GZR4, PK, PD

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

Interventions

DRUGGZR4

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

DRUGInsulin Degludec

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of TEAE	Baseline to Week 6

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026