Last updated 3 months ago
Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
1328 patients around the world
Available in United States, Argentina
Arrowhead Pharmaceuticals
9Research sites
1328Patients around the world
This study is for people with
Hypertriglyceridemia
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L).Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 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.Acute pancreatitis within 4 weeks prior to screening.Body mass index >45 kg/m^2.
Sites
Sanatorio Duarte Quiros - Córdoba
Recruiting
Instituto de Investigaciones Clínicas Córdoba
Instituto de Investigaciones Clínicas (IIC) - Rosario
Recruiting
Mautalen - Salud e Investigación - CABA
Recruiting
CIPADI - Centro Integral de Prevención y Atención en Diabetes
Recruiting
Instituto CAICI - Rosario, Santa Fe
Recruiting
Centro Médico Luquez
Recruiting
Centro Privado de Medicina Familiar Mindout Research
Recruiting
Centro Médico Saavedra
StudyMUIR-3
SponsorArrowhead Pharmaceuticals
Study typeInterventional
Conditions
Hypertriglyceridemia
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06347133
