Last updated 31 days ago
Study of Plozasiran (ARO-APOC3) in Adults With Severe Hypertriglyceridemia
405 patients around the world
Available in United States, Argentina
Arrowhead Pharmaceuticals
3Research sites
405Patients around the world
This study is for people with
Hypertriglyceridemia
Severe Hypertriglyceridemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Established diagnosis of severe hypertriglyceridemia (SHTG) and prior documented evidence (medical history) of fasting TG levels of ≥ 500 mg/dL (≥5.65mmol/L).Mean fasting TG level ≥500 mg/dL (≥5.65 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period.Fasting low density lipoprotein-cholesterol (LDL-C) ≤130 mg/dL (≤3.37 mmol/L) at screening.Screening HbA1C ≤8.5%.Willing to follow diet counseling and maintain a stable low-fat diet.Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant as determined by the Investigator).
- Use of any hepatocyte-targeted small interfering ribonucleic acid (siRNA) that targets lipids and/or triglycerides within 365 days before Day 1 (except inclisiran, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.Use of any other hepatocyte-targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer.Known diagnosis of familial chylomicronemia syndrome (FCS) (type 1 Hyperlipoproteinemia) by documentation of confirmed homozygote or double heterozygote for loss-of-function mutations in type 1-causing genes.Acute pancreatitis within 4 weeks prior to screening.Body mass index >45kg/m^2.
Sites
Instituto de Investigaciones Clínicas Córdoba
Recruiting
Centro Médico Maffei - CABA, Buenos Aires
Recruiting
Centro Médico Saavedra
Recruiting
StudySHASTA-3
SponsorArrowhead Pharmaceuticals
Study typeInterventional
Conditions
Severe Hypertriglyceridemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06347003
