NCT04914546

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Jun 2021

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2022

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

June 1, 2021

Last Update Submit

November 18, 2022

Conditions

Healthy

Outcome Measures

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

    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 Outcomes (3)

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

    Predose through Day 15

  • PK: Maximum Observed Drug Concentration (Cmax) of LY3819469

    Predose through Day 15

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

    Baseline up to Week 49

Study Arms (4)

LY3819469 (Part A)

EXPERIMENTAL

Single ascending doses of LY3819469 administered subcutaneously (SC).

Drug: LY3819469

LY3819469 (Part B)

EXPERIMENTAL

Single doses of LY3819469 administered SC in Japanese Participants.

Drug: LY3819469

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered SC.

Drug: Placebo

Interventions

LY3819469DRUG

Administered SC.

LY3819469 (Part A)LY3819469 (Part B)
PlaceboDRUG

Administered SC.

Placebo (Part A)Placebo (Part B)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Qps-Mra, Llc

Miami, Florida, 33143, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78229, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Related Publications (2)

  • Karp A, Jacobs M, Barris B, Labkowsky A, Frishman WH. Lipoprotein(a): A Review of Risk Factors, Measurements, and Novel Treatment Modalities. Cardiol Rev. 2025 Jul-Aug 01;33(4):352-358. doi: 10.1097/CRD.0000000000000667. Epub 2024 Feb 28.

    PMID: 38415744DERIVED

  • Nissen SE, Linnebjerg H, Shen X, Wolski K, Ma X, Lim S, Michael LF, Ruotolo G, Gribble G, Navar AM, Nicholls SJ. Lepodisiran, an Extended-Duration Short Interfering RNA Targeting Lipoprotein(a): A Randomized Dose-Ascending Clinical Trial. JAMA. 2023 Dec 5;330(21):2075-2083. doi: 10.1001/jama.2023.21835.

    PMID: 37952254DERIVED

Study Officials

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2021

First Posted

June 4, 2021

Study Start

June 14, 2021

Primary Completion

November 9, 2022

Study Completion

November 9, 2022

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(4)SG(1)