Study of Plozasiran in Adults With Severe Hypertriglyceridemia at Risk of Acute Pancreatitis
Start Date
4/24/2025
Completion Date
6/1/2029
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 Criteria
Age Range: 18 years to No maximum
Interventions
Plozasiran
Placebo
Conditions
Locations
Research Site
Los Angeles, California 90027
United States
Clinical Research Site 4
Santa Clarita, California 91321
United States
Research Site
New Haven, Connecticut 06519
United States
Clinical Research Site 6
Springfield, Illinois 62702
United States
Research Site
Indianapolis, Indiana 46202
United States
Research Site
Kansas City, Kansas 66160
United States
Research Site
Ann Arbor, Michigan 48109
United States
Research Site
St Louis, Missouri 63110
United States
Clinical Research Site 5
North Platte, Nebraska 69101
United States
Clinical Research Site 3
Greensboro, North Carolina 27401
United States
Research Site
Wilmington, North Carolina 28412
United States
Clinical Research Site 7
Philadelphia, Pennsylvania 19107
United States
Research Site
Pittsburgh, Pennsylvania 15213
United States
Clinical Research Site 1
Mesquite, Texas 75149
United States
Clinical Research Site 2
San Antonio, Texas 78233
United States
Research Site
Seattle, Washington 98109
United States
Research Site
Ramos Mejía, Buenos Aires 1704
Argentina
Research Site
Córdoba, Córdoba Province 5000
Argentina
Research Site
Córdoba, Córdoba Province X5003DCE
Argentina
Research Site
Rosario, Santa Fe Province 2000
Argentina
Research Site
Ciudad Autonoma Buenos Aires, C1430CKE
Argentina
Research Site
Graz, 8036
Austria
Research Site
Linz, 4021
Austria
Research Site
Vienna, 1130
Austria
Research Site
Fortaleza, Ceará 60430-370
Brazil
Research Site
Belo Horizonte, Minas Gerais 30150-274
Brazil
Research Site
Belo Horizonte, Minas Gerais 30150-320
Brazil
Research Site
Belo Horizonte, Minas Gerais 30220-140
Brazil
Research Site
Curitiba, Paraná 80230-130
Brazil
Research Site
Porto Alegre, Rio Grande do Sul 90035-903
Brazil
Research Site
Porto Alegre, Rio Grande do Sul 90620-001
Brazil
Research Site
Pôrto Alegre, Rio Grande do Sul 90050-170
Brazil
Research Site
São Paulo, São Paulo 05403-900
Brazil
Research Site
São Paulo, São Paulo 99999
Brazil
Research Site
São Paulo, 01221-020
Brazil
Research Site
Burgas, 8000
Bulgaria
Research Site
Pleven, 5800
Bulgaria
Research Center
Plovdiv, 4002
Bulgaria
Research Site
Plovdiv, 4003
Bulgaria
Research Site
Rousse, 7013
Bulgaria
Research Site
Sofia, 1404
Bulgaria
Research Site
Sofia, 1431
Bulgaria
Research Site
Stara Zagora, 6000
Bulgaria
Research Center
Beijing, Beijing Municipality 100730
China
Research Site
Guiyang, Guizhou 550000
China
Research Site
Harbin, Heilongjiang 150040
China
Research Site
Luoyang, Henan 471000
China
Research Site
Luoyang, Henan 471002
China
Research Site
Zhuzhou, Hunan 412000
China
Research Center
Baotou, Inner Mongolia 014010
China
Research Site
Chifeng, Inner Mongolia 024099
China
Research Center
Nanchang, Jiangxi 330006
China
Research Center
Shanghai, Shanghai Municipality 201620
China
Research Site
Chengdu, Sichuan 610041
China
Research Center
Hangzhou, Zhejiang 310000
China
Research Site
Hangzhou, Zhejiang 310003
China
Research Site
Wenzhou, Zhejiang 325000
China
Research Site
Beijing, 100053
China
Research Site
Changsha, 410015
China
Research Site
Chengdu, 610074
China
Research Site
Ch’ang-ch’un, 130021
China
Research Site
Nanjing, 210002
China
Research Site
Barranquilla, 080020
Colombia
Research Site
Bogotá, 111211
Colombia
Research Site
Bogotá, 111411
Colombia
Research Site
Cali, 760042
Colombia
Research Site
Cali, 760046
Colombia
Research Site
Puerto Colombia, 081007
Colombia
Research Site
Budapest, 1083
Hungary
Research Site
Budapest, 1132
Hungary
Research Site
Pécs, 7624
Hungary
Research Site
Szeged, 6725
Hungary
Research Site
Amman, 11190
Jordan
Research Center
Amman, 11821
Jordan
Research Site
Amman, 11942
Jordan
Research Center
Irbid, 21166
Jordan
Research Center
Irbid, 22110
Jordan
Research Site
Guadalajara, Jalisco 44670
Mexico
Research Site
Mexico City, Mexico City 06700
Mexico
Research Site
Muscat, 123
Oman
Research Site
Riyadh, 11211
Saudi Arabia
Research Site
Riyadh, 11426
Saudi Arabia
Research Site
Riyadh, 11472
Saudi Arabia
Research Center
Belgrade, 11000
Serbia
Research Site
Belgrade, 11000
Serbia
Research Site
Pančevo, 26000
Serbia
Research Center
Zaječar, 19000
Serbia
Research Site
Singapore, 768828
Singapore
Research Site
Seongnam-si, Gyeonggi-do 13620
South Korea
Research Site
Jeonju, Jeollabuk-do 54907
South Korea
Research Site
Busan, 49201
South Korea
Research Site
Sejong, 30099
South Korea
Research Site
Seoul, 02841
South Korea
Research Site
Seoul, 05505
South Korea
Research Site
Seoul, 06351
South Korea
Research Site
Seoul, 06591
South Korea
Research Center
Gothenburg, 41345
Sweden
Research Center
Stockholm, 14186
Sweden
Research Site
Abu Dhabi, 133500
United Arab Emirates
Research Site
Abu Dhabi, 51900
United Arab Emirates
Research Site
Al Ain City, 15258
United Arab Emirates
Research Site
London, Greater London EC1M 6BQ
United Kingdom