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

NCT07144098 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Gan & Lee Pharmaceuticals.

    lead INDUSTRY

Principal Investigators

  • Liyuan Zhao Ph.D · Gan & Lee Pharmaceuticals.

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-07-12
Completion
2027-01-26

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07144098 on ClinicalTrials.gov