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Active not recruitingPhase 2

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

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

NCT IDNCT07055386
Org study IDGZR102-T2D-201

Timeline

Milestones

Study first posted2025-07-08actual
Study start2025-08-07actual
Last update posted2025-11-21actual
Primary completion2026-06-28estimated
Study completion2027-01estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.

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

1. Subjects with a history of drug abuse before screening or a history of alcohol abuse within 6 months before screening.

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
Other (unclassified)
2

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

hypoglycemic events.

Time frame:Week 24

descriptive

Secondary/protocol endpoint

hypoglycemic events.

Time frame:Week 24

descriptive

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

efficiency endpoint

Time frame:Week 24

descriptive

Secondary/protocol endpoint/low confidence

efficiency endpoint

Time frame:Week 24

descriptive

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.