A Phase 1 interventional study of LY3819469 and Placebo in Healthy, sponsored by Eli Lilly and Company. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-21.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science
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.
Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single ascending doses of LY3819469 administered subcutaneously (SC).
Drug: LY3819469
Single doses of LY3819469 administered SC in Japanese Participants.
Drug: LY3819469
Placebo administered SC.
Drug: Placebo
Placebo administered SC.
Drug: Placebo
Administered SC.
Administered SC.
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
Plan to share: No
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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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