A Study of LY3473329 in Participants With Impaired and Normal Renal Function

Last updated: October 25, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

1

Condition

Kidney Disease

Nephropathy

Kidney Failure (Pediatric)

Treatment

LY3473329

Clinical Study ID

NCT05778864
18638
J2O-MC-EKBE
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main purpose of this study is to assess the amount of study drug (LY3473329) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3473329 will also be evaluated in these participants. The study will last up to 8 weeks including screening period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)

  • Men who agree to use highly effective or effective methods of contraception, womenof childbearing potential (WOCP) who agree to use highly effective or effectivemethods of contraception, and women not of childbearing potential (WNOCBP) mayparticipate in this trial

  • Have clinical laboratory test results within the normal reference range for thepopulation

Exclusion

Exclusion Criteria:

  • Have a history or presence of an underlying disease, or surgical, physical, medical,or psychiatric condition that, in the opinion of the investigator, would potentiallyaffect participant safety within the study

  • Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/orpulse rate that, in the opinion of the investigator, increases the risks associatedwith participating in the study

  • Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemiasymptoms

  • Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age

  • Smoke more than 10 cigarettes per day or the equivalent

  • Have donated blood of more than 500 milliliter (mL) within 3 months prior toscreening

Study Design

Total Participants: 47
Treatment Group(s): 1
Primary Treatment: LY3473329
Phase: 1
Study Start date:
March 17, 2023
Estimated Completion Date:
September 06, 2024

Connect with a study center

  • Velocity Clinical Research

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Advanced Pharma CR, LLC

    Miami, Florida 33417
    United States

    Site Not Available

  • Advanced Pharma Clinical Research

    Miami, Florida 33147-4040
    United States

    Active - Recruiting

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Site Not Available

  • Alliance for Multispecialty Research - Clinical Research Consortium

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee 37920
    United States

    Site Not Available

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