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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy; Renal Insufficiency

Treatments: Drug: LY3819469

Study type: Interventional

Funder types: Industry

Identifiers

NCT05841277

18731

J3L-MC-EZED (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 3 patient groups

LY3819469 (Control)

Experimental group

Description:

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

Treatment:

Drug: LY3819469

LY3819469 (Severe Renal Impairment)

Experimental group

Description:

LY3819469 administered SC to participants with severe renal impairment

Treatment:

Drug: LY3819469

LY3819469 (End-Stage Renal Disease)

Experimental group

Description:

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

Treatment:

Drug: LY3819469