A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
Launched by IONIS PHARMACEUTICALS, INC. · Oct 4, 2021
Trial Information
Current as of June 19, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called olezarsen for patients with severe hypertriglyceridemia, which means they have very high levels of triglycerides (a type of fat) in their blood. The main goal is to see how well olezarsen works compared to a placebo (a dummy treatment) in lowering these triglyceride levels. Participants in this trial will need to be between the ages of 65 and 74 and have a fasting triglyceride level of at least 500 mg/dL. They must also be on standard cholesterol-lowering medications, which should be stable for at least four weeks before joining the study.
If you or a family member qualify for this trial, you can expect to be monitored closely throughout the study. This means regular check-ups and tests to see how well the treatment is working and to ensure safety. However, certain health conditions could prevent someone from participating, such as very high blood sugar levels or liver issues. It's important to talk to your doctor about whether this trial might be a good option.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
- • Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.
- Key Exclusion Criteria:
- • Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
- • Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
- • Total bilirubin \> upper limit of normal unless due to Gilbert's syndrome
- • Estimated GFR \< 30 mL/min/1.73 m\^2
About Ionis Pharmaceuticals, Inc.
Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company specializing in the discovery and development of innovative RNA-targeted therapies for the treatment of various diseases, including neurological disorders, cardiovascular conditions, and rare diseases. With a robust pipeline of drug candidates, Ionis leverages its proprietary antisense technology to modulate gene expression and address unmet medical needs. The company's commitment to advancing precision medicine is underscored by its collaborative partnerships and a strong focus on research and development, positioning Ionis as a pioneer in the field of RNA therapeutics.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
New York, New York, United States
Saint Louis, Missouri, United States
Scottsdale, Arizona, United States
Providence, Rhode Island, United States
Kansas City, Kansas, United States
Melbourne, Victoria, Australia
Camperdown, New South Wales, Australia
Dallas, Texas, United States
Hull, , United Kingdom
Rotterdam, , Netherlands
Bron, , France
Marseille, , France
Herlev, , Denmark
Turku, , Finland
Adelaide, , Australia
Grafton, Auckland, New Zealand
Blackpool, , United Kingdom
Manassas, Virginia, United States
Jacksonville, Florida, United States
Rapid City, South Dakota, United States
Aalborg, , Denmark
Utrecht, , Netherlands
Viborg, , Denmark
Hannover, , Germany
Petach Tikva, , Israel
Napoli, , Italy
Aarhus, , Denmark
Utrecht, , Netherlands
Jerusalem, , Israel
Bloemfontein, Free State, South Africa
Milano, , Italy
Córdoba, , Spain
Dordrecht, , Netherlands
Esbjerg, , Denmark
Hamburg, , Germany
Ostrava, , Czechia
Chattanooga, Tennessee, United States
Ede, , Netherlands
Stockholm, , Sweden
Roma, , Italy
Chicoutimi, Quebec, Canada
Columbus, Georgia, United States
Köln, , Germany
Las Vegas, Nevada, United States
Barcelona, , Spain
Poznan, , Poland
Miami, Florida, United States
Council Bluffs, Iowa, United States
Nijmegen, , Netherlands
New York, New York, United States
Szekesfehervar, , Hungary
Tel Hashomer, , Israel
Great Neck, New York, United States
Columbus, Ohio, United States
Ankara, , Turkey
Mount Airy, North Carolina, United States
Arnhem, , Netherlands
Kocaeli, , Turkey
Christchurch, , New Zealand
Dijon, , France
Be'er Sheva, , Israel
Flint, Michigan, United States
Munroe Falls, Ohio, United States
Norfolk, Virginia, United States
Dimitrovgrad, , Bulgaria
Monroe, Louisiana, United States
La Jolla, California, United States
Huntington Beach, California, United States
Haifa, , Israel
Blagoevgrad, , Bulgaria
Madrid, , Spain
Barcelona, , Spain
Boca Raton, Florida, United States
Gabrovo, , Bulgaria
Oak Brook, Illinois, United States
Reẖovot, , Israel
Towson, Maryland, United States
Los Angeles, California, United States
Manchester, , United Kingdom
Montréal, Quebec, Canada
Ocala, Florida, United States
Newquay, Cornwall, United Kingdom
Sofia, , Bulgaria
Roma, , Italy
Morgantown, West Virginia, United States
Québec, Quebec, Canada
Amsterdam, , Netherlands
A Coruña, , Spain
Saint Louis, Missouri, United States
Prague, , Czechia
Chula Vista, California, United States
Oklahoma City, Oklahoma, United States
Madrid, , Spain
Tarzana, California, United States
Trinity, Florida, United States
Ann Arbor, Michigan, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Medford, Oregon, United States
Cedar Park, Texas, United States
West Jordan, Utah, United States
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Cape Town, Western Cape, South Africa
Parow, Western Cape, South Africa
Barcelona, , Spain
Barcelona, , Spain
Sevilla, , Spain
Woolloongabba, Queensland, Australia
Nyíregyháza, Szabolcs Szatmar Bereg, Hungary
Hatvan, Heves, Hungary
Borsod, , Hungary
Katowice, , Poland
Skierniewice, , Poland
Centurion, Gauteng, South Africa
Cape Town, , South Africa
Veliko Tarnovo, , Bulgaria
Wroclaw, , Poland
łódz, , Poland
Clayton S., Victoria, Australia
Uherské Hradiště, , Czechia
Debrecen, , Hungary
Goteborg, Västra Götalands Län, Sweden
Burgas, , Bulgaria
Montana, , Bulgaria
Liskeard, Cornwall, United Kingdom
Milano, , Italy
Lindley, Huddersfield, United Kingdom
Smolyan, , Bulgaria
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Brandýs Nad Labem, , Czechia
Veszprém, , Hungary
Palermo, , Italy
Lisbon, , Portugal
Saint Herblain, , France
Saint Leonards, New South Wales, Australia
Náchod, , Czechia
Oslo, , Norway
Brezno, , Slovakia
Frederiksberg, , Denmark
Herning, , Denmark
Paris, , France
Coimbra, , Portugal
Košice, , Slovakia
Ruse, , Bulgaria
Sofia, , Bulgaria
Debrecen, , Hungary
Bologna, , Italy
Newtown, , New Zealand
Porto, , Portugal
Chatsworth, , South Africa
Hradec Králové, , Czechia
Budapest, , Hungary
Tarragona, , Spain
Konya, , Turkey
Tampa, Florida, United States
Kosice, , Slovakia
Union City, New Jersey, United States
Birmingham, Alabama, United States
Jerusalem, , Israel
Aveiro, , Portugal
Lyne, West Bromwich, United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Preston, , United Kingdom
Saint Petersburg, Florida, United States
Rochdale, England, United Kingdom
Sheffield, England, United Kingdom
Syosset, New York, United States
Vila Nova De Gaia, , Portugal
Chiefland, Florida, United States
Miramar, Florida, United States
Brooklyn, New York, United States
Prague, , Czechia
Nyíregyháza, , Hungary
Sugar Land, Texas, United States
Hradec Králové, , Czechia
Ylitornio, , Finland
Miskolc, , Hungary
Košice, , Slovakia
Stara Zagora, , Bulgaria
Plovdiv, , Bulgaria
Sliven, , Bulgaria
Sliven, , Bulgaria
Sofia, , Bulgaria
Salem, North Carolina, United States
Montpellier, , France
Niagara Falls, New York, United States
Berlin, , Germany
Dresden, , Germany
Markkleeberg, , Germany
Chicago, Illinois, United States
Lincoln, Nebraska, United States
Heidelberg, , Germany
Middletown, New York, United States
Papenburg, , Germany
Witten, , Germany
Budapest, , Hungary
Tel Aviv, , Israel
Tarnów, , Poland
Bratislava, , Slovakia
Corby, Northamptonshire, United Kingdom
Sheffield, , United Kingdom
Haifa, , Israel
Cornwell, , United Kingdom
Svidnik, , Slovakia
Poole, Dorset, United Kingdom
İzmir, , Turkey
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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