Last updated 2 months ago

Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia

1328 patients around the world
Available in United States
Arrowhead Pharmaceuticals
2Research 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

Instituto de Investigaciones Clínicas Córdoba
Instituto de Investigaciones Clínicas Córdoba
Dean Funes 1161, Córdoba
Instituto de Investigaciones Clínicas (IIC) - Rosario
Paraguay 160, S2000CVD Rosario, Santa Fe, Argentina
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