NCT05841277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2024

Completed
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

9 months

First QC Date

April 24, 2023

Last Update Submit

March 28, 2024

Conditions

Renal InsufficiencyHealthy

Outcome Measures

Primary Outcomes (3)

  • 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

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

    PK: AUC0-∞ of LY3819469

    Predose up to 85 days postdose

  • PK: Maximum observed concentration (Cmax) of LY3819469

    PK: Cmax of LY3819469

    Predose up to 85 days postdose

Study Arms (3)

LY3819469 (Control)

EXPERIMENTAL

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

Drug: LY3819469

LY3819469 (Severe Renal Impairment)

EXPERIMENTAL

LY3819469 administered SC to participants with severe renal impairment

Drug: LY3819469

LY3819469 (End-Stage Renal Disease)

EXPERIMENTAL

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

Drug: LY3819469

Interventions

LY3819469DRUG

Administered SC.

LY3819469 (Control)LY3819469 (End-Stage Renal Disease)LY3819469 (Severe Renal Impairment)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Floridian Clinical Research

Miami, Florida, 33016, United States

Location

Advanced Pharma CR, LLC

Miami, Florida, 33417, United States

Location

Omega Research Consultants

Orlando, Florida, 32808, United States

Location

Nucleus Networks

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 3, 2023

Study Start

April 25, 2023

Primary Completion

January 9, 2024

Study Completion

January 9, 2024

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)