A Study of LY3819469 in Healthy Participants

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04914546

Enrollment

Registered

2021-06-04

Start date

2021-06-14

Completion date

2022-11-09

Last updated

2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Interventions

DRUGLY3819469

Administered SC.

DRUGPlacebo

Administered SC.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline up to Week 49	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary

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

Countries

Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026