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A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

KRAKEN: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Oral Once-Daily LY3473329 in Adults With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

NCT05563246•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants must be at least 40 years old
•Participants with Lp(a) ≥175 nmol/L at randomization, measured at the central laboratory.
•High risk for cardiovascular events defined as documented coronary artery disease (CAD), stroke, or peripheral artery disease or atherosclerotic cardiovascular disease (ASCVD) risk equivalents (familial hypercholesterolemia or type 2 diabetes).
•Participants on the following medications according to local practice must be on a stable regimen for at least 4 weeks prior to randomization and expected to remain on a stable regimen through the end of the post-treatment follow-up period.
•* lipid-lowering drugs
•* testosterone, estrogens, anti-estrogens, progestins, selective estrogen receptor modulators, or growth hormone
•Have a body mass index within the range 18.5 to 40 kilogram/square meter (kg/m²), inclusive.
•Males who agree to use highly effective or effective methods of contraception may participate in this trial.
•Women of childbearing potential (WOCBP) who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial.

Exclusion Criteria

•Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
•Any of the following, or other events indicating unstable medical condition in the opinion of the investigator, within 3 months of randomization:
•* major surgery
•* coronary, carotid, or peripheral arterial revascularization
•* stroke or transient ischemic attack
•* myocardial infarction or unstable angina
•* acute limb ischemia
•Have, in the 6 months prior to day 1, uncontrolled Type 1 or Type 2 diabetes
•Have uncontrolled hypertension

Locations (42)

Care Access - Baltimore

Baltimore, Maryland, United States

Care Access - Dorchester

Dorchester, Massachusetts, United States

Care Access - Lima

Lima, Ohio, United States

Core Research Group

Brisbane, Queensland, Australia

Nightingale Research

Adelaide, South Australia, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

CEDOES

Vitória, Espírito Santo, Brazil

Pesquisa Clínica em Diabetes - Dra Rosângela Réa

Curitiba, Paraná, Brazil

Centro de Pesquisa Clinica do Coracao

Acaraju, Sergipe, Brazil

Key Dates

Start Date

November 24, 2022

Primary Completion Date

March 14, 2024

Completion Date

March 14, 2024

Last Updated

March 25, 2025

Enrollment

233

ACTUAL participants

Conditions

Lipoprotein Disorder

Interventions

LY3473329

DRUG

Placebo

DRUG

The Effect of Lipoprotein (a) on Arterial Stiffness, Endothelial Function and Myocardial Deformation

NCT07324902

Lipoprotein DisorderArterial Stiffness+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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