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

Launched by ELI LILLY AND COMPANY · Apr 24, 2023

Keywords

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Gender

ALL

Eligibility criteria

• 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