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Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Sponsor: Arrowhead Pharmaceuticals
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.
Official title: Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults With Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
288
Start Date
2025-04-24
Completion Date
2029-06
Last Updated
2026-09-21
Healthy Volunteers
No
Conditions
Interventions
Plozasiran
ARO-APOC3 injection
Placebo
sterile normal saline (0.9% NaCl)
Locations (140)
Research Site
Los Angeles, California, United States
Clinical Research Site 4
Santa Clarita, California, United States
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New Haven, Connecticut, United States
Clinical Research Site 6
Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
Clinical Research Site 5
North Platte, Nebraska, United States
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New York, New York, United States
Clinical Research Site 3
Greensboro, North Carolina, United States
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Wilmington, North Carolina, United States
Clinical Research Site 7
Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
Clinical Research Site 1
Mesquite, Texas, United States
Clinical Research Site 2
San Antonio, Texas, United States
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Seattle, Washington, United States
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Ramos Mejía, Buenos Aires, Argentina
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Córdoba, Córdoba Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Ciudad Autonoma Buenos Aires, Argentina
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Graz, Austria
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Linz, Austria
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Vienna, Austria
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Brussels, Belgium
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Ghent, Belgium
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Fortaleza, Ceará, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Pôrto Alegre, Rio Grande do Sul, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, Brazil
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Burgas, Bulgaria
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Dimitrovgrad, Bulgaria
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Pleven, Bulgaria
Research Center
Plovdiv, Bulgaria
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Plovdiv, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Montreal, Quebec, Canada
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Guiyang, Guizhou, China
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Harbin, Heilongjiang, China
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Luoyang, Henan, China
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Luoyang, Henan, China
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Nanyang, Henan, China
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Zhuzhou, Hunan, China
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Baotou, Inner Mongolia, China
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Chifeng, Inner Mongolia, China
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Nanchang, Jiangxi, China
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Shenyang, Liaoning, China
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Shanghai, Shanghai Municipality, China
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Chengdu, Sichuan, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, China
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Changsha, China
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Chengdu, China
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Ch’ang-ch’un, China
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Nanjing, China
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Barranquilla, Colombia
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Bogotá, Colombia
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Bogotá, Colombia
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Cali, Colombia
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Cali, Colombia
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Floridablanca, Colombia
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Puerto Colombia, Colombia
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Rijeka, Croatia
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Zagreb, Croatia
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Hradec Králové, Czechia
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Batumi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Tbilisi, Georgia
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Budapest, Hungary
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Budapest, Hungary
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Pécs, Hungary
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Szeged, Hungary
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Ashkelon, Israel
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Beersheba, Israel
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Haifa, Israel
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Jerusalem, Israel
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Petah Tikva, Israel
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Ramat Gan, Israel
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Rehovot, Israel
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Tel Aviv, Israel
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Amman, Jordan
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Amman, Jordan
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Amman, Jordan
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Irbid, Jordan
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Irbid, Jordan
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Riga, Latvia
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Riga, Latvia
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Tukums, Latvia
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Kaunas, Lithuania
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Kaunas, Lithuania
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Querétaro City, Querétaro, Mexico
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Durango, Mexico
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Muscat, Oman
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Riyadh, Saudi Arabia
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Riyadh, Saudi Arabia
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Riyadh, Saudi Arabia
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Belgrade, Serbia
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Belgrade, Serbia
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Pančevo, Serbia
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Zaječar, Serbia
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Singapore, Singapore
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Singapore, Singapore
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Moldava nad Bodvou, Slovakia
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Nitra, Slovakia
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Rožňava, Slovakia
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Seongnam-si, Gyeonggi-do, South Korea
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Jeonju, Jeollabuk-do, South Korea
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Busan, South Korea
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Sejong, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Gothenburg, Sweden
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Stockholm, Sweden
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Abu Dhabi, United Arab Emirates
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Abu Dhabi, United Arab Emirates
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Al Ain City, United Arab Emirates
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Torquay, Devon, United Kingdom
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London, Greater London, United Kingdom
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Dundee, Tayside Region, United Kingdom