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A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Subjects With Type 2 Diabetes Mellitus and Poor Blood Glucose Control by Diet and Exercise

Study acronym: Optimum 1
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 25, 2025 (before its estimated August 7, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Not Yet Recruiting to Active, Not Recruiting Enrollment target: estimated 270 to confirmed 274 · Study sites: 0 to 1 · Start date changed from estimate of Jan 17, 2025 to Jan 16, 2025v2 Show 3 more changesShow less
    • Enrollment target: estimated 270 to confirmed 274
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 17, 2025 to Jan 16, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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 Diet and Exercise
Trial Details
NCT Number NCT06777238
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 274 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov