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

NCT06778967
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,100
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Lead sponsor
Gan & Lee Pharmaceuticals.
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Start date
2025-02-13
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Number of sites
1
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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
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Acronym
Optimum 2
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Short title
A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
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Official title
A Multicenter, Randomized, Active-controlled Phase III Clinical Study to Evaluate 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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2026-12-11
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First posted
2025-01-16
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Registry last updated
2025-11-25
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Primary completion date
2026-12-11
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Start date
2025-02-13
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Participants
1,100
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Participant count basis
Estimated
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Planned participants
1,100
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Protocol amendments
1
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Gan & Lee Pharmaceuticals.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06778967
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ClinicalTrials.gov ID
NCT06778967
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Change from Baseline in Hemoglobin A1c (HbA1c)(%)

    Timeframe: Baseline, Week 44

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

    Timeframe: week 44

  2. Proportion of subjects with salvage therapy.

    Timeframe: week 44

  3. Change from baseline in weight (kg)

    Timeframe: week 44

  4. Percent change in weight from baseline (%)

    Timeframe: week 44

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

    Timeframe: week 44

  6. Treatment emergent adverse events (TEAEs)

    Timeframe: week 44

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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).

  • 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.
Sources for eligibility
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  • Tianjin Medical University General HospitalTianjin, China
Sources for sites
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Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (1)