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A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 21, 2025 (before its estimated February 7, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Start date: Feb 17, 2025 to Feb 15, 2025 · Site details revisedv3 Show 2 more changesShow less
    • Start date: Feb 17, 2025 to Feb 15, 2025
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jan 10, 2025 to Feb 17, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 10, 2025 to Feb 17, 2025
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study will be conducted to compare the efficacy, safety and patient-reported outcome of once-weekly GZR4 and once-daily Insulin Degludec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.
Trial Details
NCT Number NCT06767748
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Diabetes
Enrollment 620 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov