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CompletedNCT06547502Updated Dec 9, 2024

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

A Phase 1 interventional study of GZR4 in Diabetes, sponsored by Gan and Lee Pharmaceuticals, USA. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-09.

Sponsored by Gan and Lee Pharmaceuticals, USA · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes

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Keywords

  • GZR4
  • kidney
03

In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 16 is below the median of 43 across 1,504 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Gan and Lee Pharmaceuticals, USA is the lead sponsor of 29 studies on the registry; 5 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 2 (25%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Normal renal function

    GFR between 90-130 ml/min

    Drug: GZR4

  • Experimental
    Mildly decreased renal function

    GFR between 60-90 ml/min

    Drug: GZR4

  • Experimental
    moderately decreased renal function

    GFR between 30-60 ml/min

    Drug: GZR4

Interventions

  • DrugGZR4

    single dose

06

What researchers measure

Primary outcomes

  1. AUC0-inf

    Time frame: Day1-Day29

  2. AUC0-last

    Time frame: Day1-Day29

  3. Cmax

    Time frame: Day1-Day29

Secondary outcomes

  1. Incidence of TEAE

    Time frame: Day1-Day29

  2. AUC0-168h

    Time frame: Day1-Day29

  3. Tmax

    Time frame: Day1-Day29

  4. T1/2

    Time frame: Day1-Day29

07

Study locations

1 site
  • Site 1
    Suzhou, Jiangsu, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06547502
Lead sponsor
Gan and Lee Pharmaceuticals, USA
Responsible party
Sponsor
First posted
Aug 9, 2024
Start date
Jul 3, 2024
Primary completion
Aug 20, 2024
Completion
Sep 5, 2024
Last update
Dec 9, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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