A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients with Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis

Are you eligible to participate in this study?

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

  • Conditions:
    Severe Hypertriglyceridemia
  • Age: Between 18 years - 80 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Adults without Familial chylomicronemia syndrome (FCS) due to Lipoprotein lipase (LPL) loss of function mutations
    2. Documented history of 1 HTG-associated Acute pancreatitis (AP) episode within 24 months of screening
    3. Fasting serum TG value >880 mg/dL (10 mmol/L) determined during the screening period
    4. Stable dose of lipid-lowering therapy (= 8 weeks) and willingness to maintain a stable regimen throughout the study
    5. Body mass index =18.0 and =45.0 kg/m2
    6. Compliance with a stable diet and exercise regimen at screening and willingness to continue the diet through the end of the study
    7. Willing and able to comply with clinic visits and study-related procedures
    8. Must provide informed consent
    9. Able to understand and complete study-related questionnaires

You may not be eligible for this study if the following are true:

    1. Hospitalization for AP within 4 weeks of screening
    2. Known genetic Familial chylomicronemia syndrome (FCS)
    3. Symptomatic gallstone disease within 6 months prior to screening
    4. Use of any medication or nutraceutical known to alter serum lipids which has not been part of a stable therapeutic regimen for at least 8 weeks, and there are no plans to change the regimen during the study
    5. Presence of any clinically significant, uncontrolled endocrine disease
    6. Any clinically significant abnormality identified at the time of screening that, in the judgment of the investigator or any sub-investigator, would preclude safe completion of the study or constrain endpoints assessment
    7. Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
    8. History of heart failure
    9. Within 3 months of screening, a history of myocardial infarction (MI), unstable angina leading to hospitalization, coronary artery bypass grafting (CABG) surgery, percutaneous coronary interventions (PCI), uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, transient ischemic attack (TIA), carotid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease
    10. Significant concomitant illness including, but not limited to: cardiac, renal, neurological, endocrinological, hepatic, metabolic, or lymphatic disease, that would adversely affect the patient's participation in the study
    11. History of cancer
    12. Participation in a clinical research evaluating an investigational drug
    13. History or evidence of drug or alcohol abuse
    14. Positive polymerase chain reaction (PCR) or equivalent test for COVID-19 or suspected SARS-CoV-2 infection
    15. History of serious hypersensitivity reactions to evinacumab or to any of the excipients
    16. Has received a COVID-19 vaccination (initial series or booster) within 1-week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1-week prior to start of the study

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.