search
Back to results

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

Primary Purpose

Renal Insufficiency, Healthy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3819469
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Insufficiency

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Floridian Clinical Research
  • Advanced Pharma CR, LLCRecruiting
  • Omega Research ConsultantsRecruiting
  • Nucleus NetworksRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

LY3819469 (Control)

LY3819469 (Severe Renal Impairment)

LY3819469 (End-Stage Renal Disease)

Arm Description

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

LY3819469 administered SC to participants with severe renal impairment

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

Outcomes

Primary Outcome Measures

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
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
PK: AUC0-∞ of LY3819469
PK: Maximum observed concentration (Cmax) of LY3819469
PK: Cmax of LY3819469

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
October 18, 2023
Sponsor
Eli Lilly and Company
search

1. Study Identification

Unique Protocol Identification Number
NCT05841277
Brief Title
A Study of LY3819469 in Participants With Impaired and Normal Renal Function
Official Title
Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
March 4, 2024 (Anticipated)
Study Completion Date
March 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3819469 (Control)
Arm Type
Experimental
Arm Description
LY3819469 administered subcutaneously (SC) to participants with normal renal function
Arm Title
LY3819469 (Severe Renal Impairment)
Arm Type
Experimental
Arm Description
LY3819469 administered SC to participants with severe renal impairment
Arm Title
LY3819469 (End-Stage Renal Disease)
Arm Type
Experimental
Arm Description
LY3819469 administered SC to participants with end-stage renal disease (ESRD)
Intervention Type
Drug
Intervention Name(s)
LY3819469
Intervention Description
Administered SC.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469
Description
PK: AUC0-tlast of LY3819469
Time Frame
Predose up to 85 days postdose
Title
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
Description
PK: AUC0-∞ of LY3819469
Time Frame
Predose up to 85 days postdose
Title
PK: Maximum observed concentration (Cmax) of LY3819469
Description
PK: Cmax of LY3819469
Time Frame
Predose up to 85 days postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@Lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Floridian Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Advanced Pharma CR, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
305-220-2727
First Name & Middle Initial & Last Name & Degree
Kimberly Cruz
Facility Name
Omega Research Consultants
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
407-512-1054
First Name & Middle Initial & Last Name & Degree
Kwabena Ayesu
Facility Name
Nucleus Networks
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
612-315-6490
First Name & Middle Initial & Last Name & Degree
Trisha Shamp

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs