Phase 3 Study of Plozasiran in Adults With Hypertriglyceridemia
Launched by ARROWHEAD PHARMACEUTICALS · Mar 29, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called plozasiran, which is an injection aimed at helping adults with a condition known as hypertriglyceridemia (HTG), where there are high levels of triglycerides (a type of fat) in the blood. The trial is in its Phase 3 stage, which means it’s one of the final steps before the treatment could potentially be approved for general use. Participants will receive either the plozasiran injection or a placebo (a harmless substance with no active treatment) four times over a year, with doses given every three months. The goal is to see if plozasiran is safe and effective in lowering triglyceride levels.
To be eligible for this trial, participants must be adults aged 18 and older with a confirmed diagnosis of hypertriglyceridemia, specifically with triglyceride levels between 150 and 499 mg/dL. They should also be willing to follow dietary advice and be on standard medications for lowering lipids, unless they have had issues with those medications. Participants can expect regular check-ins and tests to monitor their health throughout the study. It's important to note that there are some restrictions on previous treatments participants may have received, so those interested should discuss their medical history with the study team.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Established diagnosis of hypertriglyceridemia (HTG) and prior documented evidence (medical history) of mean fasting TG level ≥150 mg/dL (≥1.69 mm/L) and ≤499 mg/dL (≤5.64 mmol/L)
- • Mean fasting TG level ≥150 mg/dL (≥1.69 mmol/L) and ≤499 mg/dL (≤5.64 mmol/L) collected at 2 separate and consecutive visits at least 7 days apart and no more than 17 days apart during the screening period
- • Fasting low density lipoprotein-cholesterol (LDL-C) ≤ 130 mg/dL (≤3.37 mmol/L) at screening
- • Screening HbA1c ≤8.5%
- • Willing to follow diet counseling and maintain a stable low-fat diet
- • Must be on standard of care lipid-lowering medications per local guidelines (unless documented as intolerant 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, which is permitted). Administration of investigational drug and inclisiran must be separated by at least 4 weeks.
- • Use of any other hepatocyte targeted siRNA or antisense Oligonucleotide molecule within 60 days or within 5-half-lives before Day 1 based on plasma pharmacokinetics (PK), whichever is longer
- • Acute pancreatitis within 4 weeks prior to screening
- • Body mass index \>45 kg/m\^2
- • Note: Additional Inclusion/Exclusion criteria may apply per protocol
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing transformative therapies for the treatment of genetic diseases and cancer. Utilizing its proprietary RNA interference (RNAi) technology platform, Arrowhead aims to create targeted therapies that address the underlying causes of diseases at the molecular level. The company's robust pipeline includes candidates designed to silence specific genes implicated in various conditions, with an emphasis on advancing innovative solutions through rigorous clinical trials. Committed to scientific excellence and patient-centric approaches, Arrowhead Pharmaceuticals strives to deliver groundbreaking treatments that significantly improve patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Philadelphia, Pennsylvania, United States
Madrid, , Spain
Valencia, , Spain
Zaragoza, , Spain
Wilkes Barre, Pennsylvania, United States
Houston, Texas, United States
Park Ridge, Illinois, United States
New York, New York, United States
Cincinnati, Ohio, United States
Minneapolis, Minnesota, United States
Clayton, Victoria, Australia
Laval, Quebec, Canada
Heidelberg, Victoria, Australia
Long Beach, California, United States
A Coruña, , Spain
Olive Branch, Mississippi, United States
Manassas, Virginia, United States
Lincoln, California, United States
Clearwater, Florida, United States
Victoria, Texas, United States
Barcelona, , Spain
Louisville, Kentucky, United States
Columbus, Ohio, United States
Summit, New Jersey, United States
Tomball, Texas, United States
Chattanooga, Tennessee, United States
Houston, Texas, United States
Columbus, Ohio, United States
Morehead City, North Carolina, United States
Chicoutimi, Quebec, Canada
Blagoevgrad, , Bulgaria
A Coruña, La Coruña, Spain
Saint Louis, Missouri, United States
Hradec Králové, , Czechia
Bardejov, , Slovakia
Victoria, British Columbia, Canada
Budapest, , Hungary
Savannah, Georgia, United States
Sugar Land, Texas, United States
Quebec, , Canada
Cape Town, Western Cape, South Africa
London, , United Kingdom
Rozzano, Milano, Italy
Gdynia, , Poland
Miami Lakes, Florida, United States
Omaha, Nebraska, United States
Pleven, , Bulgaria
Sofia, , Bulgaria
Elkhart, Indiana, United States
Sofia, , Bulgaria
Fort Worth, Texas, United States
Ruse, , Bulgaria
Canoga Park, California, United States
Montclair, California, United States
Macon, Georgia, United States
Sofia, , Bulgaria
Milano, , Italy
Jefferson City, Missouri, United States
Sofia, , Bulgaria
Barcelona, , Spain
Bronx, New York, United States
North Vancouver, British Columbia, Canada
Trutnov, , Czechia
Haskovo, , Bulgaria
Sofia, , Bulgaria
Olomouc, , Czechia
Miskolc, , Hungary
Bydgoszcz, , Poland
Bratislava, , Slovakia
Cape Town, Western Cape, South Africa
Sofia, , Bulgaria
Kraków, , Poland
Québec, Quebec, Canada
Rosario, Santa Fe, Argentina
Merewether, New South Wales, Australia
Sarnia, Ontario, Canada
Rosario, Santa Fe, Argentina
Fort Mill, South Carolina, United States
Budapest, , Hungary
Orlando, Florida, United States
Bologna, , Italy
Overland Park, Kansas, United States
Norman, Oklahoma, United States
San Antonio, Texas, United States
Katowice, , Poland
Greenville, South Carolina, United States
Bydgoszcz, , Poland
Garden Grove, California, United States
Mount Dora, Florida, United States
Houston, Texas, United States
Krugersdorp, Gauteng, South Africa
Lake City, Florida, United States
Las Vegas, Nevada, United States
Toruń, , Poland
Missouri City, Texas, United States
New York, New York, United States
Bountiful, Utah, United States
Panorama City, California, United States
Oklahoma City, Oklahoma, United States
Zalaegerszeg, , Hungary
Uherské Hradiště, , Czechia
Houston, Texas, United States
Sugar Hill, Georgia, United States
Wilmington, North Carolina, United States
Rochester, New York, United States
Budapest, , Hungary
Warsaw, , Poland
Kraków, , Poland
Colorado Springs, Colorado, United States
Houston, Texas, United States
Annapolis, Maryland, United States
Norfolk, Nebraska, United States
Beverly Hills, California, United States
Sevlievo, , Bulgaria
Ostrava, , Czechia
Slaný, , Czechia
Riverhead, New York, United States
Hialeah, Florida, United States
Redding, California, United States
łódź, , Poland
Asheboro, North Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Brampton, Ontario, Canada
El Paso, Texas, United States
Baltimore, Maryland, United States
Pensacola, Florida, United States
Omaha, Nebraska, United States
Powell, Tennessee, United States
South Bend, Indiana, United States
Topeka, Kansas, United States
Flint, Michigan, United States
Oklahoma City, Oklahoma, United States
Tamarac, Florida, United States
Laredo, Texas, United States
Plano, Texas, United States
Huntington Beach, California, United States
Sarasota, Florida, United States
Newport, Pennsylvania, United States
North Miami, Florida, United States
Vestal, New York, United States
Beavercreek, Ohio, United States
Horsham, Pennsylvania, United States
Oxnard, California, United States
Wrocław, , Poland
Lake Forest, California, United States
Birmingham, Alabama, United States
Saint George, Utah, United States
Waterloo, Ontario, Canada
Indianapolis, Indiana, United States
Lawrenceville, Georgia, United States
Québec, Quebec, Canada
Houston, Texas, United States
Metairie, Louisiana, United States
Stara Zagora, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Halifax, , Canada
Plymouth, Devpn, United Kingdom
Byala, , Bulgaria
Pessac, Gironde, France
Paris, , France
Magdeburg, Sachsen Anhalt, Germany
Békéscsaba, , Hungary
łódź, , Poland
Prešov, , Slovakia
Mobile, Alabama, United States
Blacktown, New South Wales, Australia
Kyustendil, , Bulgaria
Pleven, , Bulgaria
Sofia, , Bulgaria
Warsaw, , Poland
Córdoba, Cordoba, Argentina
Ciudad Autonoma De Buenos Aires, , Argentina
Burgas, , Bulgaria
Plovdiv, , Bulgaria
Hodonín, , Czechia
Veszprém, , Hungary
Palermo, Sicily, Italy
żarów, Swidnica, Poland
Dimitrovgrad, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Marseille, Bouches Du Rhône, France
Wallerfing, Bayern, Germany
Pécs, , Hungary
Wrocław, , Poland
Zamość, , Poland
Centurion, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Bronx, New York, United States
Winston Salem, North Carolina, United States
Seattle, Washington, United States
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Montréal, Quebec, Canada
Praha 4, Prague, Czechia
Brno, , Czechia
Náchod, , Czechia
Praha 10, , Czechia
Praha 4 Krc, , Czechia
ústí Nad Labem, , Czechia
Lyon, Rhone, France
Deggingen, Baden Wuerttemberg, Germany
Budapest, , Hungary
Kaposvar, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Brescia, , Italy
Elbląg, , Poland
Malbork, , Poland
Szczecin, , Poland
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Košice, , Slovakia
Moldava Nad Bodvou, , Slovakia
Nové Zámky, , Slovakia
Roznava, , Slovakia
Durban, Kwazulu Natal, South Africa
Cape Town, Western Cape, South Africa
Wrocław, , Poland
Caba, Buenos Aires, Argentina
Slaný, , Czechia
Teplice, , Czechia
Caba, Buenos Aires, Argentina
Córdoba, Cordoba, Argentina
Godoy Cruz, Mendoza, Argentina
Pretoria, Gauteng, South Africa
Marseille, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported