A Study of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

NCT06256523 | Completed Phase 1

• 1 other identifier: GL-GLP-CH2001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (2)

• Number of adverse events and serious adverse events

  29 weeks

• Changes from baseline in hemoglobin A1c (HbA1c) at the end of the study

  26 weeks

Secondary Outcomes (2)

• Trough concentrations of GZR18 following consecutive doses

  26 weeks

• HbA1c control rate (proportions of subjects with HbA1c < 6.5 % and HbA1c < 7.0 %)

  26 weeks

Study Arms (2)

GZR18

EXPERIMENTAL

GZR18 injection s.c.

Drug: GZR18

Placebo

PLACEBO COMPARATOR

Placebo injection s.c.

Other: Placebo

Interventions

GZR18 DRUG

0.5mg-13mg

GZR18

Placebo OTHER

administered the same volume as GZR18

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chinese adults, male and female, aged 18-65 years (both inclusive; subject to the date of signing of ICF).
• Diagnosis of type 2 diabetes mellitus according to the diagnostic and classification criteria for diabetes mellitus issued by the World Health Organization (WHO) in 1999.
• Patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs.
• Hemoglobin A1c (HbA1c) ≥ 7.0% and ≤ 10 % at screening;
• Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening.
• Those who have no birth and sperm donation plans, and voluntarily take effective contraceptive measures from the signing of ICF to 3 months after the last dose. A negative pregnancy test for women of childbearing potential at screening.
• Fully understanding the study objectives, the nature of the study, methods used and adverse reactions that may occur in the study, willing to enter the study and sign the ICF, and capable of communicating well with the investigator, and understanding and abiding by the requirements of the study.

You may not qualify if:

• Diabetes mellitus other than T2DM, such as type 1 diabetes mellitus.
• Fasting C-peptide \< 0.3 nmol/L.
• Use of any DPP-4 inhibitors, insulin secretagogues such as sulfonylureas, TZDs and/or GLP-1 analogs within 3 months prior to screening.
• Continuous insulin use for more than 14 days within 1 year prior to screening (time of insulin use for gestational diabetes mellitus is excluded from this limit).
• Treatment with growth hormone, diuretics, etc., that may affect insulin levels as judged by the investigator within 6 months prior to screening.
• Immunoserologic panel test results \[infection screening tests for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and Treponema pallidum antibody\] assessed by the investigator as abnormal and clinically significant.

Sponsors & Collaborators

• Gan and Lee Pharmaceuticals, USA: lead

Study Sites (1)

Gan & Lee Pharmaceuticals Co., Ltd

Beijing, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Liyuan Zhao, Ph.D

  Gan & Lee Pharmaceuticals.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 13, 2024
• Study Start: June 29, 2022
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

CN (1)