Find Familial Hypertriglyceridemia Clinical Trials Near You
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)
Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• 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)
Locations
United States
California
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Los Angeles
Clinical Research Site 4
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Santa Clarita
Connecticut
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New Haven
Illinois
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Springfield
Indiana
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Indianapolis
Kansas
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Kansas City
Michigan
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Ann Arbor
Missouri
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St Louis
North Carolina
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Greensboro
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Wilmington
Nebraska
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North Platte
Pennsylvania
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Philadelphia
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Pittsburgh
Texas
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Mesquite
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San Antonio
Washington
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Seattle
Other Locations
Argentina
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Ciudad Autonoma Buenos Aires
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Córdoba
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Córdoba
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Ramos Mejía
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Rosario
Austria
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Graz
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Linz
Brazil
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Belo Horizonte
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Belo Horizonte
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Belo Horizonte
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Fortaleza
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Porto Alegre
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Pôrto Alegre
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São Paulo
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São Paulo
Bulgaria
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Burgas
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Pleven
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Plovdiv
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Plovdiv
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Rousse
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Sofia
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Sofia
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Stara Zagora
China
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Baotou
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Beijing
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Beijing
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Chengdu
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Chifeng
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Guiyang
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Hangzhou
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Hangzhou
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Harbin
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Luoyang
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Nanchang
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Nanjing
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Shanghai
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Wenzhou
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Zhuzhou
Colombia
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Barranquilla
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Bogotá
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Bogotá
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Cali
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Puerto Colombia
Hungary
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Budapest
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Budapest
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Pécs
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Szeged
Jordan
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Amman
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Amman
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Amman
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Irbid
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Irbid
Mexico
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Guadalajara
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Mexico City
Oman
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Muscat
Republic of Korea
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Busan
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Jeonju
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Sejong
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Seongnam-si
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Seoul
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Seoul
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Seoul
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Seoul
Saudi Arabia
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Riyadh
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Riyadh
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Riyadh
Serbia
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Belgrade
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Belgrade
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Pančevo
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Zaječar
Sweden
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Gothenburg
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Stockholm
United Arab Emirates
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Abu Dhabi
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Abu Dhabi
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Al Ain City
Contact Information
Primary
Medical Monitor
plozasiran@arrowheadpharma.com
626-304-3400
Time Frame
Start Date:2025-04-24
Estimated Completion Date:2029-06
Participants
Target number of participants:288
Treatments
Experimental: Plozasiran Injection
Plozasiran by SC injection every 3 months (Q3M) through completion of the randomized period~Plozasiran by SC injection Q3M through completion of the OLE period
Experimental: Placebo
calculated volume to match active treatment by SC injection (randomized period)