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

Lipoprotein Disorder Clinical Trial

— KRAKEN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05563246
• Other study ID #: 18495
• Secondary ID: J2O-MC-EKBC
• Status: Completed
• Phase: Phase 2
• Start date: November 24, 2022
• Est. completion date: March 14, 2024

Study information

• Verified date: March 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: March 14, 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lipoprotein Disorder

Intervention

Drug:
• LY3473329
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Australia	Nightingale Research	Adelaide	South Australia
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Core Research Group	Brisbane	Queensland
Australia	Victorian Heart Hospital	Clayton	Victoria
Brazil	Centro de Pesquisa Clinica do Coracao	Acaraju	Sergipe
Brazil	Pesquisa Clínica em Diabetes - Dra Rosângela Réa	Curitiba	Paraná
Brazil	IBPClin - Instituto Brasil de Pesquisa Clínica	Rio de Janeiro
Brazil	CPCLIN	Sao Paulo
Brazil	Incor - Instituto do Coracao	Sao Paulo	São Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	Instituto Dante Pazzanese de Cardiology	São Paulo
Brazil	CEDOES	Vitória	Espírito Santo
China	China-Japan Union Hospital	Changchun	Jilin
China	Changzhou Second People's Hospital	Changzhou	Jiangsu
China	The First Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Fourth Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Third Hospital of Nanchang	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Third People's Hospital of Hainan Province	Sanya	Hainan
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
Germany	Private Practice - Dr. Frank Menzel	Dessau
Germany	Kath. St.-Johannes-Gesellschaft Dortmund	Dortmund	Nordrhein-Westfalen
Germany	ClinPhenomics GmbH & Co KG	Frankfurt	Hessen
Germany	Gemeinschaftpraxis Dr. med. Martin Prohaska und Dr. med. Felix Schulte	Mühldorf	Bayern
Hungary	Dél-Pesti Centrumkórház	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Flor Ferenc Hospital of Pest County	Kistarcsa	Pest
Hungary	Medifarma 98 Kft	Nyiregyhaza	Nyíregyháza
Hungary	Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ	Szeged	Csongrád
Hungary	Belvárosi Egészségház	Zalaegerszeg	Zala
Japan	Funabashi Municipal Medical Center	Funabashi	Chiba
Japan	Minamino Cardiovascular Hospital	Hachioji	Tokyo
Japan	Hiroshima City Hospital	Hiroshima
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Miyazaki Medical Association Hospital	Miyazaki
Japan	Iwate Prefectural Central Hospital	Morioka	Iwate
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Netherlands	Meander Medisch Centrum	Amersfoort	Utrecht
Netherlands	VieCuri Medisch Centrum, locatie Venlo	Venlo	Limburg
United States	Care Access - Baltimore	Baltimore	Maryland
United States	Care Access - Dorchester	Dorchester	Massachusetts
United States	Care Access - Lima	Lima	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  China,  Germany,  Hungary,  Japan,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Lipoprotein (a) Lp(a)		Baseline to Week 12
Secondary	Percentage of Participants Achieving Lp(a) <125 Nanomole/Liter (nmol/L)		Week 12
Secondary	Percent Change from Baseline for Apolipoprotein B (ApoB)		Baseline, Week 12
Secondary	Percent Change from Baseline for High Sensitivity C-reactive (hsCRP)		Baseline, Week 12
Secondary	Pharmacokinetics (PK): Trough Concentrations (Ctrough) of LY3473329	PK Ctrough of LY34723329 will be measured	Baseline to Week 12

External Links

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