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HealthyPhase 1NCT04914546

A Study of LY3819469 in Healthy Participants

A Phase 1 study testing LY3819469 in people with Healthy, run by Eli Lilly and Company at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3819469
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
5 sitesin 2 countries
Study dates
14 Jun 2021to 9 Nov 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Altasciences Clinical Los Angeles, Inc

    Cypress, California, 90630

  • Clinical Pharmacology of Miami

    Miami, Florida, 33014

  • Qps-Mra, Llc

    Miami, Florida, 33143

  • Endeavor Clinical Trials

    San Antonio, Texas, 78229

Other trials in United States

Singapore1 site

  • Lilly Centre for Clinical Pharmacology

    Singapore, 138623

Other trials in Singapore

About this study

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

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.

Conditions
Healthy
Being tested
LY3819469, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3819469Drug

    Administered SC.

  • PlaceboDrug

    Administered SC.

Study groups in NCT04914546
Study groupRoleWhat they receive
LY3819469 (Part A)ExperimentalSingle ascending doses of LY3819469 administered subcutaneously (SC).
Receives: Drug: LY3819469
LY3819469 (Part B)ExperimentalSingle doses of LY3819469 administered SC in Japanese Participants.
Receives: Drug: LY3819469
Placebo (Part A)Placebo comparatorPlacebo administered SC.
Receives: Drug: Placebo
Placebo (Part B)Placebo comparatorPlacebo administered SC.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline up to Week 49

Secondary outcomes (3)

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

    PK: AUC[0-∞] of LY3819469

    Measured: Predose through Day 15

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

    PK: Cmax of LY3819469

    Measured: Predose through Day 15

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

    PD: Change From Baseline in Fasting Lp(a)

    Measured: Baseline up to Week 49

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start14 Jun 2021
  3. Primary completion9 Nov 2022
  4. Study completion9 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914546
Sponsor's protocol ID
18075
Other IDs
J3L-MC-EZEA
Status last verified
Nov 2022
First submitted
1 Jun 2021
Last updated
21 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38415744

  • 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.

    PubMed 37952254

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3819469 in people with Healthy, run by Eli Lilly and Company at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04914546, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.

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