Last updated 25 days ago

Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis

288 patients around the world

Available in United States, Brazil

Arrowhead Pharmaceuticals

288Patients around the world

This study is for people with

Hypertriglyceridemia

Severe Hypertriglyceridemia

Requirements for the patient

From 18 Years

All Gender

Medical requirements

: Males, or nonpregnant nonlactating females who do not plan to become pregnant.
Established diagnosis of SHTG and prior documented evidence of fasting TG levels of ≥ 880 mg/dL (≥ 10 mmol/L).
Documented evidence of at least 1 prior AP event not attributed to other etiologies occurring within the last 60 months prior to Screening.
Fasting low-density lipoprotein cholesterol (LDL-C) ≤ 130 mg/dL (≤ 3.37 mmol/L) at Screening.
Screening hemoglobin A1c (HbA1c) ≤ 9.5%.
Willing to follow diet counseling and maintain a stable low-fat diet.
Must be on standard of care lipid and TG-lowering medications per local guidelines unless documented as intolerant, or a treatment failure 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.
Use of any other hepatocyte targeted siRNA or antisense oligonucleotide molecule within 60 days or within 5 half-lives before Day 1, whichever is longer.
AP ≤ 4 weeks prior to Randomization/Day 1.
Body mass index (BMI) > 45 kg/m².
Any planned bariatric surgery or similar procedures to induce weight loss starting at consent through End of Study (EOS).
Planned coronary intervention (e.g. stent placement or heart bypass) during the study.
History of arterial revascularization within 16 weeks of Screening.
History of acute coronary syndrome event within 24 weeks of Screening.
Recent atherosclerotic cardiovascular disease (ASCVD) event within 24 weeks of Screening.
Recent unstable or symptomatic cardiac arrhythmia including any associated medication changes within 90 days of Screening. Individuals with stable well-controlled atrial arrhythmia will be allowed to participate in the study.
History of pacemaker or automatic implantable cardioverter defibrillators implant within 30 days before Screening.
New York Heart Association Class III-IV heart failure or last known ejection fraction of < 30%.
Current diagnosis of nephrotic syndrome.
Chronic kidney disease, defined by an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m².
Liver disease defined as cirrhosis or Child-Pugh Class B and C, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5× Upper Limit of Normal (ULN) at Screening.

StudySHASTA-5

SponsorArrowhead Pharmaceuticals

Study typeInterventional

Conditions

Severe Hypertriglyceridemia

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT06880770