Clinical Trial

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
Active, Not Recruiting Phase 3
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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.
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 Diet and Exercise
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-10.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-11-20
Trial Details
NCT Number NCT06777238
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 274 participants
Start Date 2025-01-16
Primary Completion 2026-08-07 (estimated)
Study Completion 2027-03-10 (estimated)
Updated on ClinicalTrials.gov 2025-11-25