NCT07144098

Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Liver Insufficiency and Normal Liver Function

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Gan & Lee Pharmaceuticals. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: 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 liver function and those with mild, moderate or severe liver insufficiency. 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	3 mg-Control group
DRUG	GZR18 injection	3 mg-mild liver insufficiency
DRUG	GZR18 injection	3 mg-moderate liver insufficiency
DRUG	GZR18 injection	3 mg-severe liver insufficiency

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-07-12
• Completion: 2027-01-26
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: China