This is a 2-part study. In Part A, the main purpose is to evaluate the safety and tolerability of the study drug LY3819469 in healthy participants with high lipoprotein (a) \[Lp(a)\] levels. How the body processes the study drug and the effect of the study drug on blood Lp(a) levels will also be investigated. Part B will mainly evaluate the safety and tolerability of LY3819469 as well as how the body processes the study drug in Japanese participants. The study may last up to 53 and 29 weeks for each participant in Parts A and B, respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
66
Altasciences Clinical Los Angeles, Inc
Cypress, California, United States
Clinical Pharmacology of Miami
Miami, Florida, United States
Qps-Mra, Llc
Miami, Florida, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline up to Week 49
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469
PK: AUC\[0-∞\] of LY3819469
Time frame: Predose through Day 15
PK: Maximum Observed Drug Concentration (Cmax) of LY3819469
PK: Cmax of LY3819469
Time frame: Predose through Day 15
Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)
PD: Change From Baseline in Fasting Lp(a)
Time frame: Baseline up to Week 49
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Lilly Centre for Clinical Pharmacology
Singapore, Singapore