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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05089084Tipo: INTERVENTIONALInicio: 14 de dic de 2021Fin estimado: 1 de abr de 2026

Traducción no disponible, mostrando original

Resumen

The purpose of AROAPOC3-3001 is to evaluate the efficacy and safety of ARO-APOC3 (plozasiran) in adult participants with familial chylomicronemia syndrome (FCS). Participants who have met all eligibility criteria will be randomized to receive 4 doses of plozasiran or matching placebo administered subcutaneously. Participants who complete the randomized period will continue in a 2-year open-label extension period where all participants will receive plozasiran.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Fasting triglycerides (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

Criterios de exclusión

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
On treatment with human immunodeficiency virus (HIV) antiretroviral therapy
Seropositive for hepatitis B virus (HBV) or hepatitis C virus (HCV)
New York Heart Association (NYHA) Clas II, III, or IV heart failure

Intervenciones

drug

Plozasiran

ARO-APOC3 subcutaneous (SC) injection

drug

Placebo

sterile normal saline (0.9% NaCl) SC injection

Ubicaciones

Clinical Site 10

Córdoba, Argentina

Clinical Site 11

Formosa, Argentina

Patrocinadores

PrincipalArrowhead Pharmaceuticals

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