A Study of LY3819469 in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914546
• Other study ID #: 18075
• Secondary ID: J3L-MC-EZEA
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2021
• Est. completion date: November 9, 2022

Study information

• Verified date: November 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 9, 2022
• Est. primary completion date: November 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3819469
Administered SC.
• Placebo
Administered SC.

Locations

Country	Name	City	State
Singapore	Lilly Centre for Clinical Pharmacology	Singapore
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-8]) of LY3819469	PK: AUC[0-8] of LY3819469	Predose through Day 15
Secondary	PK: Maximum Observed Drug Concentration (Cmax) of LY3819469	PK: Cmax of LY3819469	Predose through Day 15
Secondary	Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)	PD: Change From Baseline in Fasting Lp(a)	Baseline up to Week 49