NCT07141030

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

To Assess the Pharmacokinetic (PK) Differences of GZR18 Injection Between Subjects With Renal Impairment and Those With Normal Renal Function, Providing a Basis for Establishing a Clinical Dosing Regimen for Patients With Renal Impairment

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obesity/Overweight

Interventions

Type	Name	Description
DRUG	GZR18 injection	GZR18 injection:3mg

Timeline

• Start date: 2025-04-11
• Primary completion: 2025-10-09
• Completion: 2026-03-31
• First posted: 2025-08-26
• Last updated: 2025-11-21

Locations

1 site across 1 country: China