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RECRUITING
NCT06880770
PHASE3

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

Sponsor: Arrowhead Pharmaceuticals

View on ClinicalTrials.gov

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

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

Plozasiran

ARO-APOC3 injection

DRUG

Placebo

sterile normal saline (0.9% NaCl)

Locations (61)

Research Site

Los Angeles, California, United States

Clinical Research Site 4

Santa Clarita, California, 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

St Louis, Missouri, United States

Clinical Research Site 5

North Platte, Nebraska, 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

Clinical Research Site 1

Mesquite, Texas, United States

Clinical Research Site 2

San Antonio, Texas, United States

Research Site

Graz, Austria

Research Site

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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Porto Alegre, Rio Grande do Sul, Brazil

Research Site

Pôrto Alegre, Rio Grande do Sul, Brazil

Research Site

Burgas, Bulgaria

Research Site

Pleven, Bulgaria

Research Center

Plovdiv, Bulgaria

Research Site

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

Research Center

Beijing, Beijing Municipality, China

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Guiyang, Guizhou, China

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Harbin, Heilongjiang, China

Research Center

Baotou, Inner Mongolia, China

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Chifeng, Inner Mongolia, China

Research Center

Nanchang, Jiangxi, China

Research Center

Shanghai, Shanghai Municipality, China

Research Center

Hangzhou, Zhejiang, China

Research Site

Hangzhou, Zhejiang, China

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Beijing, China

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Nanjing, China

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Budapest, Hungary

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Budapest, Hungary

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Szeged, Hungary

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Amman, Jordan

Research Center

Amman, Jordan

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Amman, Jordan

Research Center

Irbid, Jordan

Research Center

Irbid, Jordan

Research Site

Muscat, Oman

Research Center

Belgrade, Serbia

Research Site

Belgrade, Serbia

Research Site

Pančevo, Serbia

Research Center

Zaječar, Serbia

Research Site

Jeonju, Jeollabuk-do, South Korea

Research Site

Busan, South Korea

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Sejong, South Korea

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Seoul, South Korea

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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