A Study of LY3819469 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2022-11-09

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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3819469 (Part A)

Single ascending doses of LY3819469 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

LY3819469 (Part B)

Single doses of LY3819469 administered SC in Japanese Participants.

Group Type EXPERIMENTAL

LY3819469

Intervention Type DRUG

Administered SC.

Placebo (Part A)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Placebo (Part B)

Placebo administered SC.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC.

Interventions

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LY3819469

Administered SC.

Intervention Type DRUG

Placebo

Administered SC.

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes