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A Study to Compare the Efficacy and Safety of GZR102 Injection and GZR18 Injection in Type 2 Diabetes Mellitus
A Phase II Clinical Study to Compare the Efficacy and Safety of Once-Weekly GZR102 Injection and Bi-weekly GZR18 Injection in Type 2 Diabetes Mellitus With Inadequate Glycemic Control on GLP-1 Receptor Agonists, With or Without Oral Antidiabetic Drugs
Lead sponsor
Asset
GZR18
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
—
Enrollment
90
estimated
Study population
Type 2 diabetes
Key I/E criterion
—
Primary endpoint
•Efficiency endpoint
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. Males or females aged ≥ 18 years at the time of signing the Informed Consent Form (ICF).
3. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
4. According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
5. No Insulin treatment within one year before the screening. 6. Subjects who have been on a stable dose of GLP-1RA therapy for diabetes mellitus as per the package insert for ≥ 90 days before screening, with or without antidiabetic drugs.
Exclusion criteria
2. Subjects with a history of allergy to ≥ 2 drugs, or known or suspected hypersensitivity or intolerance to the IMP or similar products and their excipients.
3. Subjects who have taken any concomitant medication, that is known to affect weight or glucose metabolism for more than 14 consecutive days within the 90 days before screening, or who require long-term use during the study.
4. Participation in a clinical study of another IMP, surgery, or device within 90 days before screening.
5. Severe chronic complications of diabetes at the time of screening. 6. Diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic diabetic coma in the 90 days prior to screening.
7. Grade 3 hypoglycemic events within 1 year prior to screening. 8. Subjects with significant hematological disorders in screening; or subjects who have donated bloods (> 400 mL), experienced significant blood loss (> 400 mL) or received a transfusion within 90 days before screening.
9. Subjects with a history of (acute or chronic) pancreatitis in or before screening.
10. Subjects with a history of malignant tumors within 5 years before screening or the presence of potential malignant tumors in screening.
11. Subjects with a personal history or first-degree family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
12. Subjects with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening. 13. History of renal transplant or current renal replacement therapy. 14. Expect significant changes in diet, exercise, working circadian rhythm and other lifestyles during the study that may affect glycemia control, or unwilling to comply with relevant lifestyle restrictions during the study.
15. Subjects who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study
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
Safety / tolerability / PK
2 endpointshypoglycemic events.
Time frame:Week 24
descriptive
hypoglycemic events.
Time frame:Week 24
descriptive
Other (unclassified)
2 endpointsefficiency endpoint
Time frame:Week 24
descriptive
efficiency endpoint
Time frame:Week 24
descriptive
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.