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OpenTrials
Completed

NCT Number: NCT05038787

A Study of LY3473329 in Healthy Japanese Participants

The main purpose of this study is to evaluate the safety and tolerability of LY3473329 in healthy Japanese participants. The study will also assess how fast LY3473329 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to about 71 days, inclusive of screening period.

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Key information

Conditions

Healthy

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are overtly healthy as determined through medical history and physical examination.
  • Are males who agree to follow contraception requirements or females not of childbearing potential.
  • Are 1st generation Japanese defined as the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

Exclusion criteria

  • Have a history or presence of medical illness.
  • Have significant history of or current psychiatric disorders.
  • Have abnormalities in the 12-lead ECG and blood pressure.
  • Have received treatment with siRNA within the past 12 months or any antisense oligonucleotide within the past 6 months for lipoprotein(a) [Lp(a)].

Treatment and study plan

LY3473329

Drug

Administered orally.

Placebo

Drug

Administered orally.

Primary outcomes

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

    Time frame: Baseline through Day 43

    A summary of TEAEs, 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 (AUC) of LY3473329

    Time frame: Predose on Day 1 through Day 43

    PK: AUC of LY3473329

  2. PK: Maximum Concentration (Cmax) of LY3473329

    Time frame: Predose on Day 1 through Day 43

    PK: Cmax of LY3473329

  3. PK: Time to Maximum Concentration (Tmax) of LY3473329

    Time frame: Predose on Day 1 through Day 43

    PK: Tmax of LY3473329

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Investigator- and Participant-Blind, Placebo-Controlled Study of LY3473329 Multiple-Ascending Dosing in Healthy Japanese Participants

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 9, 2021
Registry last updated
Jun 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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