A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus

NCT ID: NCT06778967

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-13
• Study Completion Date: 2026-12-11

Brief Summary

The main purpose of this study is to investigate the Efficacy and Safety of GZR18 Injection in Chinese Subjects with Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas

Conditions

Type 2 Diabetes Mellitus (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GZR18 Dose 1

Participants will receive GZR18 subcutaneously (SC).

Group Type: EXPERIMENTAL

GZR18

Intervention Type: DRUG

Administered SC

GZR18 Dose 2

Participants will receive GZR18 subcutaneously (SC).

Group Type: EXPERIMENTAL

GZR18

Intervention Type: DRUG

Administered SC

semaglutide

Participants will receive semaglutide subcutaneously (SC).

Group Type: ACTIVE_COMPARATOR

semaglutide

Intervention Type: DRUG

Administered SC

Interventions

GZR18

Administered SC

Intervention Type: DRUG

semaglutide

Administered SC

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• T2DM is diagnosed for at least 12 weeks according to the diagnostic criteria of diabetes mellitus issued by the World Health Organization (WHO) in 1999 and the supplementary diagnostic criteria of WHO in 2011 (HbA1c diagnosis is recommended).
• Antidiabetic drugs that meet any of the following within 8 weeks before screening:

• A stable dose of metformin hydrochloride monotherapy at a dose of ≥ 1500 mg/day or the maximum tolerated dose ;

• A stable dose of metformin (≥ 1500 mg/day or the maximum tolerated dose ) in combination with SGLT2 inhibitors;

• A stable dose of metformin (≥1500 mg/day or a maximum tolerated dose < 1500 but ≥ 1000 mg/day) in combination with a stable daily dose of sulfonylureas.
• HbA1c ≥ 7.5% and ≤ 11% at screening (central laboratory).
• BG < 15 mmol/L at screening (central laboratory).

Exclusion Criteria

• Type 1 diabetes mellitus or special type of diabetes mellitus.
• Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar state within 6 months before screening, or diabetic ketosis at screening/before randomization.
• Severe chronic complications of diabetes (such as proliferative retinopathy or maculopathy, diabetic painful neuropathy, intermittent claudication, or diabetic foot) at screening or before randomization.
• History of acute or chronic pancreatitis and pancreatic injury before screening.
• History or relevant family history of medullary thyroid cancer, multiple endocrine neoplasia (MEN) 2A or 2B before screening.
• Any laboratory test indicator meeting the following criteria at screening or before randomization:
• Calcitonin level ≥ 50 ng/L (pg/mL) at screening.
• ALT ≥ 3.0 × upper limit of normal (ULN) or AST ≥ 3.0 × ULN or total bilirubin ≥ 2.0 × ULN.
• Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2, calculated using CKD-EPI equation (see Appendix 3).
• Fasting triglyceride (TG) ≥ 5.7 mmol/L or 500 mg/dL.
• Blood amylase or lipase > 1.5 × ULN.
• Hemoglobin ≤ 100 g/L for women and ≤ 110 g/L for men.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gan & Lee Pharmaceuticals.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Medical University General Hospital

Tianjin, , China

Countries

China

Other Identifiers

GZR18-T2DM-302

Identifier Type: -

Identifier Source: org_study_id