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Trial · Interventional

Status unknownPhase 2Registry data

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

NCTNCT06256549 (opens ClinicalTrials.gov in a new tab)Other idGL-GLP-CH2004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
272 participants (actual)
Sponsor
Gan and Lee Pharmaceuticals, USA · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
9 Aug 2023
Primary completion
20 Jul 2024 (estimated)
Completion
20 Jul 2024 (estimated)
First posted
13 Feb 2024
Last update posted
23 Feb 2024
Conditions
Type 2 Diabetes

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202320242025
  1. Ph 2

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

    NCT06256549

    9 Aug 2023 to est. 20 Jul 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GZR18Drug
  • SemaglutideDrug

Arms2

  • Experimental

    GZR18

    GZR18 injection s.c.

  • Active comparator

    Semaglutide

    Semaglutide injection s.c.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks

    Time frame · 24 weeks

Secondary outcomes(2)

  1. HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)

    Time frame · 24 weeks

    Registry description

    Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks

  2. The overall incidence of adverse events and the incidence of serious adverse events

    Time frame · 27 weeks

    Registry description

    Compared with Semaglutide injection, GZR18 injection after continuous administration for 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2026

3 results

Weekly and Biweekly Treatment With Bofanglutide Versus Semaglutide in Chinese Patients With Type 2 Diabetes : A Phase 2b Randomized Clinical Trial.

Liu et al. 2026Annals of internal medicine

PMID 42372276DOI 10.7326/annals-25-04623PUB-42372276

Full text at the publisher3 results
Publisher pageSee results (3)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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