RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Arrowhead Pharmaceuticals • ClinicalTrials.gov ID: NCT06880770

Registry updated: 2026-09-21

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Description

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.

Interventions

Plozasiran (Drug)
ARO-APOC3 injection
Placebo (Drug)
sterile normal saline (0.9% NaCl)

Eligibility criteria

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

Conditions

Severe Hypertriglyceridemia

Locations

Research Site — Los Angeles, California, United States
Clinical Research Site 4 — Santa Clarita, California, United States
Research Site — New Haven, Connecticut, United States
Clinical Research Site 6 — Springfield, Illinois, United States
Research Site — Indianapolis, Indiana, United States
Research Site — Kansas City, Kansas, United States
Research Site — Ann Arbor, Michigan, United States
Research Site — St Louis, Missouri, United States
Clinical Research Site 5 — North Platte, Nebraska, United States
Research Site — New York, New York, United States
Clinical Research Site 3 — Greensboro, North Carolina, United States
Research Site — Wilmington, North Carolina, United States
Clinical Research Site 7 — Philadelphia, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Clinical Research Site 1 — Mesquite, Texas, United States
Clinical Research Site 2 — San Antonio, Texas, United States
Research Site — Seattle, Washington, United States
Research Site — Ramos Mejía, Buenos Aires, Argentina
Research Site — Córdoba, Córdoba Province, Argentina
Research Site — Córdoba, Córdoba Province, Argentina
Research Site — Rosario, Santa Fe Province, Argentina
Research Site — Ciudad Autonoma Buenos Aires, Argentina
Research Site — Graz, Austria
Research Site — Linz, Austria
Research Site — Vienna, Austria
Research Site — Brussels, Belgium
Research Site — Ghent, Belgium
Research Site — Fortaleza, Ceará, Brazil
Research Site — Belo Horizonte, Minas Gerais, Brazil
Research Site — Belo Horizonte, Minas Gerais, Brazil
Research Site — Belo Horizonte, Minas Gerais, Brazil
Research Site — Curitiba, Paraná, Brazil
Research Site — Porto Alegre, Rio Grande do Sul, Brazil
Research Site — Porto Alegre, Rio Grande do Sul, Brazil
Research Site — Pôrto Alegre, Rio Grande do Sul, Brazil
Research Site — São Paulo, São Paulo, Brazil
Research Site — São Paulo, São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Burgas, Bulgaria
Research Site — Dimitrovgrad, Bulgaria
Research Site — Pleven, Bulgaria
Research Center — Plovdiv, Bulgaria
Research Site — Plovdiv, Bulgaria
Research Site — Rousse, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Sofia, Bulgaria
Research Site — Stara Zagora, Bulgaria
Research Site — Montreal, Quebec, Canada
Research Center — Beijing, Beijing Municipality, China
Research Site — Guangzhou, Guangdong, China
Research Site — Guiyang, Guizhou, China
Research Site — Harbin, Heilongjiang, China
Research Site — Luoyang, Henan, China
Research Site — Luoyang, Henan, China
Research Site — Nanyang, Henan, China
Research Site — Zhuzhou, Hunan, China
Research Center — Baotou, Inner Mongolia, China
Research Site — Chifeng, Inner Mongolia, China
Research Center — Nanchang, Jiangxi, China
Research Site — Shenyang, Liaoning, China
Research Center — Shanghai, Shanghai Municipality, China
Research Site — Chengdu, Sichuan, China
Research Center — Hangzhou, Zhejiang, China
Research Site — Hangzhou, Zhejiang, China
Research Site — Wenzhou, Zhejiang, China
Research Site — Beijing, China
Research Site — Changsha, China
Research Site — Chengdu, China
Research Site — Ch’ang-ch’un, China
Research Site — Nanjing, China
Research Site — Barranquilla, Colombia
Research Site — Bogotá, Colombia
Research Site — Bogotá, Colombia
Research Site — Cali, Colombia
Research Site — Cali, Colombia
Research Site — Floridablanca, Colombia
Research Site — Puerto Colombia, Colombia
Research Site — Rijeka, Croatia
Research Site — Zagreb, Croatia
Research Site — Hradec Králové, Czechia
Research Site — Batumi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Tbilisi, Georgia
Research Site — Budapest, Hungary
Research Site — Budapest, Hungary
Research Site — Pécs, Hungary
Research Site — Szeged, Hungary
Research Site — Ashkelon, Israel
Research Site — Beersheba, Israel
Research Site — Haifa, Israel
Research Site — Jerusalem, Israel
Research Site — Petah Tikva, Israel
Research Site — Ramat Gan, Israel
Research Site — Rehovot, Israel
Research Site — Tel Aviv, Israel
Research Site — Amman, Jordan
Research Center — Amman, Jordan
Research Site — Amman, Jordan
Research Center — Irbid, Jordan
Research Center — Irbid, Jordan
Research Site — Riga, Latvia
Research Site — Riga, Latvia
Research Site — Tukums, Latvia
Research Site — Kaunas, Lithuania
Research Site — Kaunas, Lithuania
Research Site — Guadalajara, Jalisco, Mexico
Research Site — Mexico City, Mexico City, Mexico
Research Site — Querétaro City, Querétaro, Mexico
Research Site — Durango, Mexico
Research Site — Muscat, Oman
Research Site — Riyadh, Saudi Arabia
Research Site — Riyadh, Saudi Arabia
Research Site — Riyadh, Saudi Arabia
Research Center — Belgrade, Serbia
Research Site — Belgrade, Serbia
Research Site — Pančevo, Serbia
Research Center — Zaječar, Serbia
Research Site — Singapore, Singapore
Research Site — Singapore, Singapore
Research Site — Moldava nad Bodvou, Slovakia
Research Site — Nitra, Slovakia
Research Site — Rožňava, Slovakia
Research Site — Seongnam-si, Gyeonggi-do, South Korea
Research Site — Jeonju, Jeollabuk-do, South Korea
Research Site — Busan, South Korea
Research Site — Sejong, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Center — Gothenburg, Sweden
Research Center — Stockholm, Sweden
Research Site — Abu Dhabi, United Arab Emirates
Research Site — Abu Dhabi, United Arab Emirates
Research Site — Al Ain City, United Arab Emirates
Research Site — Torquay, Devon, United Kingdom
Research Site — London, Greater London, United Kingdom
Research Site — Dundee, Tayside Region, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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