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

Study Overview
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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.

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

Conditions
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Healthy, Renal Insufficiency

Intervention / Treatment
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* Drug: LY3819469


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3819469 (Control)<br>LY3819469 administered subcutaneously (SC) to participants with normal renal function | Drug: LY3819469<br>* Administered SC.<br>|
| Experimental: LY3819469 (Severe Renal Impairment)<br>LY3819469 administered SC to participants with severe renal impairment | Drug: LY3819469<br>* Administered SC.<br>|
| Experimental: LY3819469 (End-Stage Renal Disease)<br>LY3819469 administered SC to participants with end-stage renal disease (ESRD) | Drug: LY3819469<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469 | PK: AUC0-tlast of LY3819469 | Predose up to 85 days postdose | 
| PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469 | PK: AUC0-∞ of LY3819469 | Predose up to 85 days postdose | 
| PK: Maximum observed concentration (Cmax) of LY3819469 | PK: Cmax of LY3819469 | Predose up to 85 days postdose |