A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events
NCT ID: NCT05563246
Last Updated: 2025-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
233 participants
INTERVENTIONAL
2022-11-24
2024-03-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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10 mg LY3473329
Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.
LY3473329
Administered orally
60 mg LY3473329
Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.
LY3473329
Administered orally
240 mg LY3473329
Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.
LY3473329
Administered orally
Placebo
Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.
Placebo
Administered orally
Interventions
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LY3473329
Administered orally
Placebo
Administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Kath. St.-Johannes-Gesellschaft Dortmund
Dortmund, North Rhine-Westphalia, Germany
Private Practice - Dr. Frank Menzel
Dessau, , Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, Hungary
Medifarma 98 Kft
Nyíregyháza, Nyíregyháza, Hungary
Flor Ferenc Hospital of Pest County
Kistarcsa, Pest County, Hungary
Belvárosi Egészségház
Zalaegerszeg, Zala County, Hungary
Dél-Pesti Centrumkórház
Budapest, , Hungary
Semmelweis University
Budapest, , Hungary
Funabashi Municipal Medical Center
Funabashi, Chiba, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Iwate Prefectural Central Hospital
Morioka, Iwate, Japan
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan
Minamino Cardiovascular Hospital
Hachiōji, Tokyo, Japan
Hiroshima City Hospital
Hiroshima, , Japan
Miyazaki Medical Association Hospital
Miyazaki, , Japan
VieCuri Medisch Centrum, locatie Venlo
Venlo, Limburg, Netherlands
Meander Medisch Centrum
Amersfoort, Utrecht, Netherlands
Countries
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References
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Nicholls SJ, Ni W, Rhodes GM, Nissen SE, Navar AM, Michael LF, Haupt A, Krege JH. Oral Muvalaplin for Lowering of Lipoprotein(a): A Randomized Clinical Trial. JAMA. 2025 Jan 21;333(3):222-231. doi: 10.1001/jama.2024.24017.
Nicholls SJ, Nelson AJ, Michael LF. Oral agents for lowering lipoprotein(a). Curr Opin Lipidol. 2024 Dec 1;35(6):275-280. doi: 10.1097/MOL.0000000000000953. Epub 2024 Sep 25.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (KRAKEN)
Other Identifiers
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J2O-MC-EKBC
Identifier Type: OTHER
Identifier Source: secondary_id
2022-501466-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
18495
Identifier Type: -
Identifier Source: org_study_id
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