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NCT06880770PHASE3Recruiting

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

Arrowhead Pharmaceuticals

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

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

Interventions

DRUG

Plozasiran

DRUG

Placebo

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Conditions

Severe Hypertriglyceridemia

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