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

JRCT ID: jRCT2031220462

Registered date:25/11/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Lipoprotein Disorder
• Date of first enrollment: 25/11/2022
• Target sample size: 233
• Countries of recruitment: Australia,Japan,Brazil,Japan,China,Japan,Germany,Japan,Hungary,Japan,Mexico,Japan,Netherlands,Japan
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

Primary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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 Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05563246