A Study of LY3473329 in Healthy Japanese Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3473329; Drug: Placebo

• Registration Number: NCT05038787
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-09
• Study Start: 2021-11-11
• Primary Completion: 2022-04-07
• Study Completion: 2022-04-07
• Status Verified: 2022-06-09
• Last Update Submitted: 2022-06-17
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)].

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3473329	LY3473329	LY3473329 administered orally.
Placebo	Placebo	Placebo administered orally.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3473329	Predose on Day 1 through Day 43	PK: AUC of LY3473329
PK: Maximum Concentration (Cmax) of LY3473329	Predose on Day 1 through Day 43	PK: Cmax of LY3473329
PK: Time to Maximum Concentration (Tmax) of LY3473329	Predose on Day 1 through Day 43	PK: Tmax of LY3473329

Trial Locations

Locations (1)

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