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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 (J2O-MC-EKBC)

A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events( KRAKEN ) (J2O-MC-EKBC)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Nov. 25, 2022

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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

Both

Lipoprotein Disorder

Parallel Assignment, Study Arms: 4

- Drug: LY3473329
Administered orally
- Drug: Placebo
Administered orally

Experimental: LY3473329 Dose 1
Participants will receive LY3473329 orally.

Experimental: LY3473329 Dose 2
Participants will receive LY3473329 orally.

Experimental: LY3473329 Dose 3
Participants will receive LY3473329 orally.

Placebo Comparator: Placebo
Participants will receive placebo orally.

Parcent Change from Baseline in Lipoprotein(a)Lp(a)
[Time Frame: Baseline to Week 12]

+81-45-722-8655

Sept. 29, 2022

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. Supporting Information: Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. URL: http://vivli.org/

Australia/Brazil/China/Germany/Hungary/Mexico/Netherlands