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Clinical Trials in the UK / NCT06880770
Recruiting Phase 3

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

NCT06880770 · tracked via the Priya Life Science UK tracker
Sponsor
Arrowhead Pharmaceuticals
Phase
Phase 3
Started
2025-04-24
Last updated
2026-09-02

Condition(s) studied

Severe Hypertriglyceridemia

Investigational drug(s) / intervention(s)

PlozasiranPlacebo

Plozasiran: ARO-APOC3 injection

Placebo: sterile normal saline (0.9% NaCl)

Study summary

This study will evaluate the efficacy and safety of plozasiran in approximately 288 adult participants with severe hypertriglyceridemia (SHTG) and history of at least two prior acute pancreatitis (AP) events not attributed to other etiologies, with at least one occurring within the last 12 months prior to screening. Eligible participants will be randomly assigned in a double-blind manner to either receive plozasiran 25 mg by subcutaneous (SC) injection every three months (Q3M) or matching placebo. Enrolled participants will be counseled to remain on the specified low-fat diet and background medications throughout the study. Following completion of the double-blind treatment period, or if the participant has a positively adjudicated AP event (whichever occurs first), participants will transition to the 12-month Open-Label Extension (OLE) treatment period receiving plozasiran 25 mg by SC injection Q3M.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Males, or nonpregnant (who do not plan to become pregnant) nonlactating females * 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) Exclusion Criteria: * 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 lives before day 1. Whichever is longer. * AP ≤ 4 weeks prior to Randomization/Day 1 * Body mass index (BMI) \> 45 kg/m\^2 * Any planned bariatric surgery or similar procedures to induce weight lost 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 m\^2 * 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 Note: Additional Inclusion/Exclusion Criteria may apply per protocol

Primary outcome measure(s)

Trial sites (121)

FacilityCityRegionStatus
Research Site Los Angeles California Recruiting
Clinical Research Site 4 Santa Clarita California Recruiting
Research Site New Haven Connecticut Recruiting
Clinical Research Site 6 Springfield Illinois Recruiting
Research Site Indianapolis Indiana Recruiting
Research Site Kansas City Kansas Recruiting
Research Site Ann Arbor Michigan Recruiting
Research Site St Louis Missouri Recruiting
Clinical Research Site 5 North Platte Nebraska Recruiting
Research Site New York New York Recruiting
Clinical Research Site 3 Greensboro North Carolina Recruiting
Research Site Wilmington North Carolina Recruiting
Clinical Research Site 7 Philadelphia Pennsylvania Recruiting
Research Site Pittsburgh Pennsylvania Recruiting
Clinical Research Site 1 Mesquite Texas Recruiting
Clinical Research Site 2 San Antonio Texas Recruiting
Research Site Seattle Washington Recruiting
Research Site Ramos Mejía Buenos Aires Recruiting
Research Site Córdoba Córdoba Province Recruiting
Research Site Córdoba Córdoba Province Recruiting
Research Site Rosario Santa Fe Province Recruiting
Research Site Ciudad Autonoma Buenos Aires Argentina Recruiting
Research Site Graz Austria Recruiting
Research Site Linz Austria Recruiting
Research Site Vienna Austria Recruiting
Research Site Fortaleza Ceará Recruiting
Research Site Belo Horizonte Minas Gerais Recruiting
Research Site Belo Horizonte Minas Gerais Recruiting
Research Site Belo Horizonte Minas Gerais Recruiting
Research Site Curitiba Paraná Recruiting
Research Site Porto Alegre Rio Grande do Sul Recruiting
Research Site Porto Alegre Rio Grande do Sul Recruiting
Research Site Pôrto Alegre Rio Grande do Sul Recruiting
Research Site São Paulo São Paulo Recruiting
Research Site São Paulo São Paulo Not Yet Recruiting
Research Site São Paulo Brazil Recruiting
Research Site Burgas Bulgaria Recruiting
Research Site Pleven Bulgaria Recruiting
Research Center Plovdiv Bulgaria Recruiting
Research Site Plovdiv Bulgaria Recruiting

+ 81 more sites — see the full list on the official registry below.

More Arrowhead Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06880770 on ClinicalTrials.gov ↗ ← All trials in the UK