A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events (KRAKEN)
Lipoprotein Disorder
About this trial
This is an interventional treatment trial for Lipoprotein Disorder focused on measuring Atherosclerotic cardiovascular disease, ASCVD, Dyslipidemia, Lipoprotein(a), Lp(a), Cardiovascular, Cardiovascular disease, Cholesterol, Hyperlipidemia
Eligibility Criteria
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
Sites / Locations
- Care Access - BaltimoreRecruiting
- Care Access - DorchesterRecruiting
- Care Access - LimaRecruiting
- Core Research GroupRecruiting
- Royal Adelaide HospitalRecruiting
- Nightingale ResearchRecruiting
- Victorian Heart HospitalRecruiting
- CEDOESRecruiting
- Pesquisa Clínica em Diabetes - Dra Rosângela RéaRecruiting
- CPCLINRecruiting
- Centro de Pesquisa Clinica do CoracaoRecruiting
- Incor - Instituto do CoracaoRecruiting
- IBPClin - Instituto Brasil de Pesquisa ClínicaRecruiting
- Instituto Dante Pazzanese de CardiologyRecruiting
- Hospital das Clinicas FMUSPRecruiting
- Third People's Hospital of Hainan ProvinceRecruiting
- The First Hospital of Harbin Medical UniversityRecruiting
- The Fourth Hospital of Harbin Medical UniversityRecruiting
- Changzhou Second People's HospitalRecruiting
- The Second Affiliated Hospital of Nanjing Medical UniversityRecruiting
- The Third Hospital of NanchangRecruiting
- China-Japan Union HospitalRecruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
- Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix SchulteRecruiting
- ClinPhenomics GmbH & Co KGRecruiting
- Kath. St.-Johannes-Gesellschaft DortmundRecruiting
- Private Practice - Dr. Frank MenzelRecruiting
- Onkoradiologiai KozpontRecruiting
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai KözpontRecruiting
- Medifarma 98 KftRecruiting
- Flor Ferenc Hospital of Pest CountyRecruiting
- Belvárosi EgészségházRecruiting
- Dél-Pesti CentrumkórházRecruiting
- Semmelweis UniversityRecruiting
- Funabashi Municipal Medical CenterRecruiting
- Kokura Memorial HospitalRecruiting
- Iwate Prefectural Central HospitalRecruiting
- Medical Corporation Heishinkai OCROM ClinicRecruiting
- Minamino Cardiovascular HospitalRecruiting
- Hiroshima City HospitalRecruiting
- Miyazaki Medical Association HospitalRecruiting
- VieCuri Medisch Centrum, locatie VenloRecruiting
- Meander Medisch CentrumRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
LY3473329 Dose 1
LY3473329 Dose 2
LY3473329 Dose 3
Placebo
Participants will receive LY3473329 orally.
Participants will receive LY3473329 orally.
Participants will receive LY3473329 orally.
Participants will receive placebo orally.