NCT06547502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 diabetes

Timeline
Completed

Started Jul 2024

Shorter than P25 for phase_1 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 7, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
Last Updated

December 9, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

August 7, 2024

Last Update Submit

December 4, 2024

Conditions

Diabetes

Keywords

GZR4kidney

Outcome Measures

Primary Outcomes (3)

  • AUC0-inf

    Day1-Day29

  • AUC0-last

    Day1-Day29

  • Cmax

    Day1-Day29

Secondary Outcomes (4)

  • Incidence of TEAE

    Day1-Day29

  • AUC0-168h

    Day1-Day29

  • Tmax

    Day1-Day29

  • T1/2

    Day1-Day29

Study Arms (3)

Normal renal function

EXPERIMENTAL

GFR between 90-130 ml/min

Drug: GZR4

Mildly decreased renal function

EXPERIMENTAL

GFR between 60-90 ml/min

Drug: GZR4

moderately decreased renal function

EXPERIMENTAL

GFR between 30-60 ml/min

Drug: GZR4

Interventions

GZR4DRUG

single dose

Mildly decreased renal functionNormal renal functionmoderately decreased renal function

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2024

First Posted

August 9, 2024

Study Start

July 3, 2024

Primary Completion

August 20, 2024

Study Completion

September 5, 2024

Last Updated

December 9, 2024

Record last verified: 2024-12

Locations

CN(1)