Last updated: March 28, 2024
Sponsor: Eli Lilly and Company
Overall Status: Completed
Phase
1
Condition
Kidney Disease
Kidney Failure (Pediatric)
Nephropathy
Treatment
LY3819469
Clinical Study ID
NCT05841277
18731
J3L-MC-EZED
Ages 18-85 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 womennot of childbearing potential (WNOCBP) may participate in this trial Participants with Normal Renal Function:
- Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney DiseaseEpidemiology 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 andnot requiring dialysis
- ESRD: Participants who have been on a stable hemodialysis schedule for at least 3months prior to planned dosing
Exclusion
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 anemiasymptoms
- Have known allergies to LY3819469, related compounds or any components of theformulation, or a history of significant atopy
- Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year
Study Design
Total Participants: 26
Treatment Group(s): 1
Primary Treatment: LY3819469
Phase: 1
Study Start date:
April 25, 2023
Estimated Completion Date:
January 09, 2024
Connect with a study center
Advanced Pharma CR, LLC
Miami, Florida 33417
United StatesSite Not Available
Floridian Clinical Research
Miami, Florida 33016
United StatesSite Not Available
Omega Research Consultants
Orlando, Florida 32808
United StatesSite Not Available
Nucleus Networks
Saint Paul, Minnesota 55114
United StatesSite Not Available
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