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

Lilly

Status and phase: Completed; Phase 2

Conditions: Lipoprotein Disorder

Treatments: Drug: Placebo; Drug: LY3473329

Study type: Interventional

Funder types: Industry

Identifiers

NCT05563246

J2O-MC-EKBC (Other Identifier)

2022-501466-21-00 (EU Trial (CTIS) Number)

18495

Details and patient eligibility

About

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.

Enrollment: 233 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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233 participants in 4 patient groups, including a placebo group

10 mg LY3473329

Experimental group

Description:

Participants received 10 milligrams (mg) of LY3473329 administered orally once daily (QD) over a 12-week treatment period.

Treatment:

Drug: LY3473329

60 mg LY3473329

Experimental group

Description:

Participants received 60 mg of LY3473329 administered orally QD over a 12-week treatment period.

Treatment:

Drug: LY3473329

240 mg LY3473329

Experimental group

Description:

Participants received 240 mg of LY3473329 administered orally QD over a 12-week treatment period.

Treatment:

Drug: LY3473329

Placebo

Placebo Comparator group

Description:

Participants received a matching dose of placebo administered orally QD over a 12-week treatment period.

Treatment:

Drug: Placebo