A Study of LY3819469 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3819469

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3819469
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female participants must not be able to get pregnant and male participants must agree to adhere to contraception restrictions Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²) For Part B, participants should be of first-generation Japanese origin Exclusion Criteria: Are currently participating in or completed a clinical trial within the last 30 days Are heavy alcohol drinkers or heavy cigarette smokers Have donated blood of more than 500 milliliters (mL) in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3819469 (Part A)<br>Single ascending doses of LY3819469 administered subcutaneously (SC). | Drug: LY3819469<br>* Administered SC.<br>|
| Experimental: LY3819469 (Part B)<br>Single doses of LY3819469 administered SC in Japanese Participants. | Drug: LY3819469<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part A)<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered SC. | Drug: Placebo<br>* Administered SC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline up to Week 49 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469 | PK: AUC[0-∞] of LY3819469 | Predose through Day 15 | 
| PK: Maximum Observed Drug Concentration (Cmax) of LY3819469 | PK: Cmax of LY3819469 | Predose through Day 15 | 
| Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a) | PD: Change From Baseline in Fasting Lp(a) | Baseline up to Week 49 |