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OpenTrials
Completed

NCT Number: NCT04914546

A Study of LY3819469 in Healthy Participants

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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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3819469

Drug

Administered SC.

Placebo

Drug

Administered SC.

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3819469

    Time frame: Predose through Day 15

    PK: AUC[0-∞] of LY3819469

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3819469

    Time frame: Predose through Day 15

    PK: Cmax of LY3819469

  3. Pharmacodynamics (PD): Change From Baseline in Fasting Lp(a)

    Time frame: Baseline up to Week 49

    PD: Change From Baseline in Fasting Lp(a)

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 4, 2021
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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