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

Study acronym: Optimum 2
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 1 · Primary completion date: Aug 28, 2026 to Dec 11, 2026 · Start date changed from estimate of Jan 7, 2025 to Feb 13, 2025v2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Aug 28, 2026 to Dec 11, 2026
    • Start date changed from estimate of Jan 7, 2025 to Feb 13, 2025
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Metformin Monotherapy or in Combination with Sodium-dependent Glucose Transporter 2 (SGLT2) Inhibitors or Sulfonylureas
Trial Details
NCT Number NCT06778967
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov