A Study of LY3819469 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3819469

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology
• United States
  • California
    • Cypress, California, United States, 90630
      • Altasciences Clinical Los Angeles, Inc
  • Florida
    • Miami, Florida, United States, 33143
      • Qps-Mra, Llc
    • Miami, Florida, United States, 33014
      • Clinical Pharmacology of Miami
  • Texas
    • San Antonio, Texas, United States, 78229
      • Endeavor Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Actual): November 9, 2022
• Study Completion (Actual): November 9, 2022

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 18, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 18075; J3L-MC-EZEA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No