RecruitingPhase 1NCT07141030

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

Sponsor

Gan & Lee Pharmaceuticals.

Enrollment

32 participants

Start Date

Apr 11, 2025

Study Type

INTERVENTIONAL

Conditions

Obesity, Overweight

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GZR18 injection for people with obesity, overweight. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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