Study of ARO-APOC3 in Adults With Familial Chylomicronemia Syndrome (FCS) (PALISADE)

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    60
  • sponsor
    Arrowhead Pharmaceuticals
Updated on 7 October 2022

Summary

The purpose or AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all protocol eligibility criteria will be randomized to receive 4 total doses of ARO-APOC3 or matching placebo administered subcutaneously.

Details
Condition Familial Chylomicronemia
Treatment Placebo, ARO-APOC3
Clinical Study IdentifierNCT05089084
SponsorArrowhead Pharmaceuticals
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Fasting TG ≥ 10 mmol/L (≥ 880 mg/dL) at screening refractory to standard lipid lowering therapy
Diagnosis of FCS
Willing to follow dietary counseling as per investigator judgement based on local standard of care
Participants of childbearing potential (males & females) must use highly-effective contraception during the study and for at least 24 weeks following the last dose of study medication. Males must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
Women of childbearing potential must have a negative pregnancy test at Screening and cannot be breastfeeding
Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1

Exclusion Criteria

Current use or use within the last 365 Days from Day 1 of any hepatocyte-targeted siRNA or antisense oligonucleotide molecule
Diabetes mellitus newly diagnosed within 12 weeks of Screening or where HbA1c ≥ 9.0% at Screening
Active pancreatitis within 12 weeks before Day 1
History of acute coronary syndrome event within 24 weeks of Day 1
History of major surgery within 12 weeks of Day 1
Uncontrolled hypertension
Known history of human immunodeficiency virus (HIV) infection
Seropositive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
New York Heart Association (NYHA) Clas II, III, or IV heart failure
Note: Additional Inclusion/Exclusion criteria may apply per protocol
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