A Phase 3 Study to Evaluate the Efficacy and Safety of ARO-APOC3 in Adults with Familial Chylomicronemia Syndrome

Are you eligible to participate in this study?

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

  • Conditions:
    Familial Chylomicronemia Syndrome (fcs)
  • Age: Between 18 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Males or non-pregnant (who do not plan to become pregnant), non-lactating females
    2. Able and willing to provide written informed consent prior to the performance of any study-specific procedures
    3. Fasting TG =10 mmol/L (?800 mg/dL) at screening
    4. A diagnosis of Familial Chylomicronemia Syndrome (FCS)
    5. Willing to follow dietary counseling as per PI judgment based on local standard of care, consistent with an intake of &le20 g of fat per day during the study

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

    1. Current use or use within the last 365 days from Day 1 of any hepatocyte-targeted siRNA or antisense oligonucleotide molecule
    2. Diabetes mellitus with any of the following:
      • Newly diagnosed within 12 weeks of screening
      • HbA1c =9.0% at screening
    3. Active pancreatitis within 12 weeks before Day 1
    4. History of acute coronary syndrome event within 24 weeks of Day 1
    5. Laboratory values outside the acceptable range at screening
    6. Uncontrolled hypertension
    7. Known history of HIV infection
    8. Positive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
    9. New York Heart Association (NYHA) Class II, III, or IV heart failure or last known ejection fraction of <30%
    10. Clinical evidence of primary hypothyroidism, primary subclinical hypothyroidism), or secondary hypothyroidism
    11. History of hemorrhagic stroke within 24 weeks of first dose
    12. History of bleeding diathesis or coagulopathy
    13. Current diagnosis of nephrotic syndrome
    14. Unwilling to limit alcohol consumption to within moderate limits for the duration of the study, as follows: not more than 14 units per week for women and men
    15. History of malignancy within the last 2 years prior to the date of consent requiring systemic treatment except for adequately treated basal cell carcinoma, squamous cell skin cancer, superficial bladder tumors, or in situ cervical cancer
    16. Use of an investigational agent or device within 30 days
    17. Any concomitant medical or psychiatric condition or social situation or any other situation that, in the PI's judgment, would make it difficult to comply with protocol requirements or put the participant at additional safety risk

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