Pharmacokinetics and Safety Profile of a Single Dose GZR4 in Subjects with Renal Impairment

The Study of Pharmacokinetics and Safety of a Single Dose of GZR4 Injection in Subjects with Mild to Moderate Renal Impairment and Subjects with Normal Renal Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06547502

Enrollment

Registered

2024-08-09

Start date

2024-07-03

Completion date

2024-09-05

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

GZR4, kidney

Brief summary

This study will be conducted to investigated the effect of decreased kidney function on PK and safety of GZR4 and to guide dosing recommendations in people with kidney impairment.

Interventions

DRUGGZR4

single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent * Meeting the pre-defined Glomerular Filtration Rate (GFR) values

Exclusion criteria

* Known or suspected hypersensitivity to trial product * Drugs known to affect creatinine clearance including cimetidine within 14 days or 5 half-lives prior to the day of dosing of GZR4 and during this trial * Individuals who routinely undergo dialysis or have a history of renal transplantation, hepatorenal syndrome, or acute kidney injury

Design outcomes

Primary

Measure	Time frame
AUC0-inf	Day1-Day29
AUC0-last	Day1-Day29
Cmax	Day1-Day29

Secondary

Measure	Time frame
Incidence of TEAE	Day1-Day29
T1/2	Day1-Day29
AUC0-168h	Day1-Day29
Tmax	Day1-Day29

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026