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Completed

NCT Number: NCT05563246

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

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.

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Key information

Conditions

Lipoprotein Disorder Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Core Research Group, Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3473329

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Percent Change From Baseline in Lp(a) - Assessed Via Intact Lp(a) Assay

    Time frame: Baseline, Week 12

    Least Squares Mean (LS Mean) was calculated using a Mixed Model for Repeated Measures (MMRM): Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time.

  2. Percent Change From Baseline in Lp(a) - Assessed Via Apo(a) Assay

    Time frame: Baseline, Week 12

    LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Treatment + Time + Treatment*Time.

Secondary outcomes

  1. Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Intact Lp(a) Assay

    Time frame: Week 12

    The percentage of participants who achieved Lp(a) less than (<) 125 nmol/L, as measured using the intact Lp(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.

  2. Percentage of Participants Who Achieved Lp(a) < 125 Nmol/L - Assessed Via Apo(a) Assay

    Time frame: Week 12

    The percentage of participants who achieved Lp(a) < 125 nmol/L, as measured using the apo(a) assay, with data analysis performed through a logistic regression model that included imputed missing values, was reported.

  3. Percent Change From Baseline in Apolipoprotein B (ApoB)

    Time frame: Baseline, Week 12

    LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time.

  4. Percent Change From Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

    Time frame: Baseline, Week 12

    LS Mean was calculated using a MMRM: Log (Actual Measurement/Baseline) = Log (Baseline) + Country + Baseline Lp(a) Stratum + Treatment + Time + Treatment*Time.

  5. Pharmacokinetics (PK): Trough Concentrations (C-trough) of LY3473329

    Time frame: Week from randomization 1, 2, 8, 12: Pre-dose

    C-trough were measured at specified time points to assess the minimum concentration of LY3473329 in the blood before the next dose was administered.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Acronym: KRAKEN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2022
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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