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A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Insulin-naive Subjects With Type 2 Diabetes Mellitus (T2DM)

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 28, 2025 (before its estimated August 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Feb 2, 2026 to Aug 1, 2026 Trial status: Not Yet Recruiting to Active, Not Recruiting · Study sites: 0 to 1 · Start date changed from estimate of Feb 14, 2025 to Feb 17, 2025v2 Show 3 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 14, 2025 to Feb 17, 2025
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Glargine U100 with Non-Insulin Antidiabetic Agents in Insulin-naive Subjects with Type 2 Diabetes Mellitusin.
Trial Details
NCT Number NCT06767735
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Diabetes
Enrollment 580 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov