A Study of LY3819469 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3819469; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04914546

J3L-MC-EZEA (Other Identifier)

18075

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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66 participants in 4 patient groups, including a placebo group

LY3819469 (Part A)

Experimental group

Description:

Single ascending doses of LY3819469 administered subcutaneously (SC).

Treatment:

Drug: LY3819469

LY3819469 (Part B)

Experimental group

Description:

Single doses of LY3819469 administered SC in Japanese Participants.

Treatment:

Drug: LY3819469

Placebo (Part A)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo

Placebo (Part B)

Placebo Comparator group

Description:

Placebo administered SC.

Treatment:

Drug: Placebo