Clinical Trial

Pharmacokinetic and Safety Study of GZR4 Injection in Subjects With Hepatic Impairment

Active, Not Recruiting Phase 1
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Record status
This record was last updated November 28, 2025 (before its estimated July 14, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, single-dose, open-label, parallel Phase 1 clinical study to evaluate the PK profile, safety, and tolerability of GZR4 Injection in subjects with mild, moderate, and severe hepatic impairment.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-18.
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-11-23
Trial Details
NCT Number NCT07193147
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Diabetes
Enrollment 36 participants
Start Date 2025-10-20
Primary Completion 2026-07-14 (estimated)
Study Completion 2026-11-04 (estimated)
Updated on ClinicalTrials.gov 2025-11-28