Clinical Trial

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function

Recruiting Phase 1
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Summary
This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal renal function and those with mild, moderate or severe renal impairment. The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-08-25.
Trial Details
NCT Number NCT07141030
Lead Sponsor Gan & Lee Pharmaceuticals.
Conditions Obesity/Overweight
Enrollment 32 participants
Start Date 2025-04-11
Primary Completion 2025-10-09 (estimated)
Study Completion 2026-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-21