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OpenTrials
Completed

NCT Number: NCT05841277

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

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.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advanced Pharma CR, LLC, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 women not of childbearing potential (WNOCBP) may participate in this trial

Participants with Normal Renal Function:

  • Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology 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 and not requiring dialysis
  • ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing

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 anemia symptoms
  • Have known allergies to LY3819469, related compounds or any components of the formulation, or a history of significant atopy
  • Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year

Treatment and study plan

LY3819469

Drug

Administered SC.

Primary outcomes

  1. Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469

    Time frame: Predose up to 85 days postdose

    PK: AUC0-tlast of LY3819469

  2. PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469

    Time frame: Predose up to 85 days postdose

    PK: AUC0-∞ of LY3819469

  3. PK: Maximum observed concentration (Cmax) of LY3819469

    Time frame: Predose up to 85 days postdose

    PK: Cmax of LY3819469

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 3, 2023
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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