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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-25

Study Completion Date

2024-01-09

Brief Summary

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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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Detailed Description

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Conditions

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Renal Insufficiency Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3819469 (Control)

LY3819469 administered subcutaneously (SC) to participants with normal renal function

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

LY3819469 (Severe Renal Impairment)

LY3819469 administered SC to participants with severe renal impairment

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

LY3819469 (End-Stage Renal Disease)

LY3819469 administered SC to participants with end-stage renal disease (ESRD)

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

Interventions

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LY3819469

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes