A Study of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

A Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus

This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: GZR18; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Gan & Lee Pharmaceuticals Co., Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• (1) Chinese adults, male or female aged between 18 and 75 (including both ends).

  (2) According to the diagnostic and classification criteria of diabetes issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria of WHO in 2011, type 2 diabetes was diagnosed for more than 3 months.

  (3) Lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening.

  (4) HbA1c (HbA1c) ≥ 7.0% and ≤ 11% during screening.

  (5) Body mass index (BMI) ≥ 18.5 kg/m2.

  (6) There is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. Fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative.

  (7) Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. During the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study.

Exclusion Criteria:

• (1) Known or suspected to be allergic to GLP-1 drugs or their excipients, or have contraindications to their use.

  (2) Those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment.

  (3) Surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage.

  (4) History of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening).

  (5) Continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); GLP-1RA drugs were used in the first 6 months; dipeptidyl peptidase-4 (DPP-4) inhibitors were used in the first month.

  (6) Growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening.

  (7) Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR18; GZR18 injection s.c.	Drug: GZR18; Titrated to low dose or middle or high dose
Active Comparator: Semaglutide; Semaglutide injection s.c.	Drug: Semaglutide; Titrated to 1.0 mg once a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)	Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks	24 weeks
The overall incidence of adverse events and the incidence of serious adverse events	Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks	27 weeks

Collaborators and Investigators

• Sponsor: Gan and Lee Pharmaceuticals, USA
• Investigators: Study Director: Liyuan Zhao, Ph.D, Gan & Lee Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2023
• Primary Completion (Estimated): July 20, 2024
• Study Completion (Estimated): July 20, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: GL-GLP-CH2004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No