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

Healthy Clinical Trial

Official title:

Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841277
• Other study ID #: 18731
• Secondary ID: J3L-MC-EZED
• Status: Completed
• Phase: Phase 1
• Start date: April 25, 2023
• Est. completion date: January 9, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: January 9, 2024
• Est. primary completion date: January 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Renal Insufficiency

Intervention

Drug:
• LY3819469
Administered SC.

Locations

Country	Name	City	State
United States	Advanced Pharma CR, LLC	Miami	Florida
United States	Floridian Clinical Research	Miami	Florida
United States	Omega Research Consultants	Orlando	Florida
United States	Nucleus Networks	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469	PK: AUC0-tlast of LY3819469	Predose up to 85 days postdose
Primary	PK: Area under the concentration versus time curve from time zero to infinity (AUC0-8) of LY3819469	PK: AUC0-8 of LY3819469	Predose up to 85 days postdose
Primary	PK: Maximum observed concentration (Cmax) of LY3819469	PK: Cmax of LY3819469	Predose up to 85 days postdose