A Study of LY3819469 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: LY3819469

• Registration Number: NCT04914546
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-04
• Study Start: 2021-06-14
• Status Verified: 2022-11
• Primary Completion: 2022-11-09
• Study Completion: 2022-11-09
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo (Part B)	Placebo	Placebo administered SC.
LY3819469 (Part A)	LY3819469	Single ascending doses of LY3819469 administered subcutaneously (SC).
LY3819469 (Part B)	LY3819469	Single doses of LY3819469 administered SC in Japanese Participants.
Placebo (Part A)	Placebo	Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)	Baseline up to Week 49	PD: Change From Baseline in Fasting Lp(a)
PK: Maximum Observed Drug Concentration (Cmax) of LY3819469	Predose through Day 15	PK: Cmax of LY3819469
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

Trial Locations

Locations (5)

Altasciences Clinical Los Angeles, Inc; 🇺🇸 Cypress, California, United States

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States

Qps-Mra, Llc; 🇺🇸 Miami, Florida, United States

Endeavor Clinical Trials; 🇺🇸 San Antonio, Texas, United States

Lilly Centre for Clinical Pharmacology; 🇸🇬 Singapore, Singapore