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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05841277
Collaborator
(none)
28
Enrollment
4
Locations
3
Arms
10.3
Anticipated Duration (Months)
7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
Anticipated Study Start Date :
Apr 25, 2023
Anticipated Primary Completion Date :
Mar 4, 2024
Anticipated Study Completion Date :
Mar 4, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3819469 (Control)

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

Drug: LY3819469
Administered SC.
Experimental: LY3819469 (Severe Renal Impairment)

LY3819469 administered SC to participants with severe renal impairment

Drug: LY3819469
Administered SC.
Experimental: LY3819469 (End-Stage Renal Disease)

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

Drug: LY3819469
Administered SC.

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

  3. PK: Maximum observed concentration (Cmax) of LY3819469 [Predose up to 85 days postdose]

    PK: Cmax of LY3819469

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Floridian Clinical Research Miami Florida United States 33016
2 Advanced Pharma CR, LLC Miami Florida United States 33417
3 Omega Research Consultants Orlando Florida United States 32808
4 Nucleus Networks Saint Paul Minnesota United States 55114

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05841277
Other Study ID Numbers:
  • 18731
  • J3L-MC-EZED
First Posted:
May 3, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 15, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Renal Insufficiency

Study Results

No Results Posted as of May 3, 2023