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

Completed · Phase 1

Conditions studied: Renal Insufficiency, Healthy

In brief

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.

Key facts

Study ID

NCT05841277

Run by

Eli Lilly and Company

People needed

26

Starts

2023-04-25

Expected to finish

2024-01-09

Last updated by the study team

2024-03-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Floridian Clinical Research — Miami, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Omega Research Consultants — Orlando, Florida, United States
• Nucleus Networks — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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