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

Phase 1

Completed

• Conditions: Healthy; Renal Insufficiency
• Interventions: Drug: LY3819469

• Registration Number: NCT05841277
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study Start: 2023-04-25
• Study First Posted: 2023-05-03
• Primary Completion: 2024-01-09
• Study Completion: 2024-01-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3819469 (End-Stage Renal Disease)	LY3819469	LY3819469 administered SC to participants with end-stage renal disease (ESRD)
LY3819469 (Control)	LY3819469	LY3819469 administered subcutaneously (SC) to participants with normal renal function
LY3819469 (Severe Renal Impairment)	LY3819469	LY3819469 administered SC to participants with severe renal impairment

Primary Outcome Measures

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

Trial Locations

Locations (4)

Nucleus Networks; 🇺🇸 Saint Paul, Minnesota, United States

Omega Research Consultants; 🇺🇸 Orlando, Florida, United States

Floridian Clinical Research; 🇺🇸 Miami, Florida, United States

Advanced Pharma CR, LLC; 🇺🇸 Miami, Florida, United States