Healthy, Renal Insufficiency
Conditions
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.
Interventions
DRUGLY3819469
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed