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

NCT06778967 | Active Not Recruiting Phase 3

• 1 other identifier: GZR18-T2DM-302
• Study Type: interventional
• Target: 1,100
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Hemoglobin A1c (HbA1c)(%)

  Baseline, Week 44

Secondary Outcomes (6)

• Change from baseline in mean 7-point self-measured blood glucose (SMBG)

  week 44

• Proportion of subjects with salvage therapy.

  week 44

• Change from baseline in weight (kg)

  week 44

• Percent change in weight from baseline (%)

  week 44

• Proportion of subjects with ≥ 5% and 10% decrease in weight from baseline.

  week 44

Study Arms (3)

GZR18 Dose 1

EXPERIMENTAL

Participants will receive GZR18 subcutaneously (SC).

Drug: GZR18

GZR18 Dose 2

EXPERIMENTAL

Participants will receive GZR18 subcutaneously (SC).

Drug: GZR18

semaglutide

ACTIVE COMPARATOR

Participants will receive semaglutide subcutaneously (SC).

Drug: semaglutide

Interventions

GZR18 DRUG

Administered SC

GZR18 Dose 1; GZR18 Dose 2

semaglutide DRUG

Administered SC

semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gan & Lee Pharmaceuticals.: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 16, 2025
• Study Start: February 13, 2025
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-10

Locations

CN (1)