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CompletedPhase 1, PHASE2

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)

Asset

GZR18

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

72

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI 18.5-35HbA1c 7-10%

Primary endpoints

Number of adverse events and serious adverse eventsChanges from baseline in hemoglobin A1c (HbA1c) at the end of the study

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06256523
Org study IDGL-GLP-CH2001

Timeline

Milestones

Study start2022-06-29actual
Primary completion2023-09-28actual
Study completion2023-09-28actual
Study first posted2024-02-13actual
Last update posted2024-02-23actual

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Chinese adults, male and female, aged 18-65 years (both inclusive; subject to the date of signing of ICF).

2. 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.

3. Patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs.

4. Hemoglobin A1c (HbA1c) ≥ 7.0% and ≤ 10 % at screening;

5. Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening.

6. 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.

7. 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.

Exclusion criteria

1. Diabetes mellitus other than T2DM, such as type 1 diabetes mellitus.

2. Fasting C-peptide < 0.3 nmol/L.

3. Use of any DPP-4 inhibitors, insulin secretagogues such as sulfonylureas, TZDs and/or GLP-1 analogs within 3 months prior to screening.

4. 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).

5. Treatment with growth hormone, diuretics, etc., that may affect insulin levels as judged by the investigator within 6 months prior to screening.

6. 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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Safety / tolerability / PK
1
Other (unclassified)
1

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

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

Time frame:26 weeks

descriptive

Secondary/protocol endpoint

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

Time frame:26 weeks

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Number of adverse events and serious adverse events

Time frame:29 weeks

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Trough concentrations of GZR18 following consecutive doses

Time frame:26 weeks

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.