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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
Lead sponsor
Assets
GZR18 / Semaglutide
Listed sites
1
Recruiting sites
—
Enrollment
272
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI ≥18.5•HbA1c 7-11%
Primary endpoint
•HbA1c, change
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
(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
(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.
Endpoints (3)
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 endpointsCompared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks
Time frame:24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)
Time frame:24 weeks
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Safety / tolerability / PK
1 endpointThe overall incidence of adverse events and the incidence of serious adverse events
Time frame:27 weeks
Treatment-emergent AEs (any)
event count, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
Provenance
Sources
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.