Last updated on May 2020

Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Homozygous Familial Hypercholesterolemia
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  1. Diagnosis of functional HoFH
  2. If undergoing LDL apheresis, must have initiated LDL apheresis at least 3 months prior to screening and must have been on a stable weekly or every other week schedule and/or stable settings for at least 8 weeks
  3. Willing to consistently maintain his/her usual low fat or heart-healthy diet for the duration of the study

Key Exclusion Criteria:

  1. LDL-C level <70 mg/dL (1.81 mmol/L) at the screening visit
  2. Background medical Lipid Modifying Therapy (LMT) (if applicable) that has not been stable before the screening visit
  3. Lipid-apheresis schedule /apheresis settings (if applicable) that have not been stable for at least 8 weeks before the screening visit
  4. Use of nutraceuticals or over-the-counter therapies known to affect lipids, at a dose/amount that has not been stable for at least 4 weeks prior to the screening visit
  5. Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
  6. Newly diagnosed (within 3 months prior to randomization visit) diabetes mellitus or poorly controlled (HbA1c >9%) diabetes
  7. History of a MI, unstable angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack, valve replacement surgery, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior to the screening visit
  8. Pregnant or breastfeeding women
  9. Sexually active women of child bearing potential (WOCBP), who are unwilling to practice a highly effective birth control method prior to the initial dose, during the study, and for 24 weeks after the last dose of study drug
  10. Sexually active men who are unwilling to use forms of medically acceptable birth control during the study drug treatment period and for 24 weeks after the last dose of study drug

Note: Other protocol defined inclusion/exclusion criteria may apply.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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