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

Completed · Phase 2 · Has a placebo group

Conditions studied: Lipoprotein Disorder

In brief

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.

Key facts

Study ID

NCT05563246

Run by

Eli Lilly and Company

People needed

233

Starts

2022-11-24

Expected to finish

2024-03-14

Last updated by the study team

2025-03-25

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Incor - Instituto do Coracao — São Paulo, São Paulo, Brazil
• IBPClin - Instituto Brasil de Pesquisa Clínica — Rio de Janeiro, Brazil
• CPCLIN — São Paulo, Brazil
• Instituto Dante Pazzanese de Cardiology — São Paulo, Brazil
• CEPIC - Centro Paulista de Investigação Clínica — São Paulo, Brazil
• Third People's Hospital of Hainan Province — Sanya, Hainan, China
• The First Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• The Fourth Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• Changzhou Second People's Hospital — Changzhou, Jiangsu, China
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China
• The Third Hospital of Nanchang — Nanchang, Jiangxi, China
• China-Japan Union Hospital — Changchun, Jilin, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China
• Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte — Mühldorf, Bavaria, Germany
• ClinPhenomics GmbH & Co KG — Frankfurt am Main, Hesse, Germany

Full record on ClinicalTrials.gov

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