A Study of LY3819469 in Participants With Impaired and Normal Renal Function

Last updated: March 28, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed

Phase

1

Condition

Kidney Disease

Kidney Failure (Pediatric)

Nephropathy

Treatment

LY3819469

Clinical Study ID

NCT05841277
18731
J3L-MC-EZED
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The main purpose of this study is to assess the amount of study drug (LY3819469) 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 LY3819469 will also be evaluated in these participants. The study will last up to 17 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 and womennot of childbearing potential (WNOCBP) may participate in this trial Participants with Normal Renal Function:
  • Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) greater than or equal to 90 milliliter per minute (mL/min) Participants with Renal Impairment:
  • Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min andnot requiring dialysis
  • ESRD: Participants who have been on a stable hemodialysis schedule for at least 3months prior to planned dosing

Exclusion

Exclusion Criteria:

  • Have a history or presence of an underlying disease, or surgical, physical, medical,or psychiatric condition
  • Have any abnormality in the 12-lead electrocardiogram (ECG)
  • Hemoglobin less than 8 grams per deciliter (g/dL) and clinically significant anemiasymptoms
  • Have known allergies to LY3819469, related compounds or any components of theformulation, or a history of significant atopy
  • Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year

Study Design

Total Participants: 26
Treatment Group(s): 1
Primary Treatment: LY3819469
Phase: 1
Study Start date:
April 25, 2023
Estimated Completion Date:
January 09, 2024

Connect with a study center

  • Advanced Pharma CR, LLC

    Miami, Florida 33417
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami, Florida 33016
    United States

    Site Not Available

  • Omega Research Consultants

    Orlando, Florida 32808
    United States

    Site Not Available

  • Nucleus Networks

    Saint Paul, Minnesota 55114
    United States

    Site Not Available

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