CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Launched by IONIS PHARMACEUTICALS, INC. · Dec 25, 2022
Trial Information
Current as of June 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called olezarsen, which is being tested for its safety and tolerability in people with a condition known as severe hypertriglyceridemia (SHTG). This condition involves very high levels of triglycerides, a type of fat, in the blood, which can lead to serious health problems. The trial is currently looking for participants aged 65 to 74 who have previously completed other studies involving olezarsen and are on a stable treatment plan for lowering their lipid (fat) levels.
If you or someone you know is considering joining this trial, participants can expect to receive olezarsen through a simple injection under the skin. It’s important that they have not developed any new health issues or had their current medications changed recently, as these factors could affect eligibility. Overall, this study aims to gather more information about how safe and well-tolerated olezarsen is for individuals dealing with high triglyceride levels.
Gender
ALL
Eligibility criteria
- Key Inclusion Criteria:
- • Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
- • Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).
- • A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses).
- Key Exclusion Criteria:
- • • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. It is acceptable to adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment.
- • NOTE: Other Inclusion/Exclusion criteria may apply.
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
Charleston, South Carolina, United States
Adelaide, South Australia, Australia
Utrecht, , Netherlands
Madrid, , Spain
Valencia, , Spain
Zaragoza, , Spain
Utrecht, , Netherlands
Barcelona, , Spain
Columbus, Ohio, United States
Tulsa, Oklahoma, United States
Badalona, , Spain
Dallas, Texas, United States
Clayton, Victoria, Australia
Rotterdam, , Netherlands
Taichung, , Taiwan
Turku, , Finland
Leuven, , Belgium
Adelaide, , Australia
Rotterdam, , Netherlands
Tainan, , Taiwan
Sevilla, , Spain
Athens, , Greece
Sevilla, , Spain
Towson, Maryland, United States
Rapid City, South Dakota, United States
Odessa, Texas, United States
Tel Aviv, , Israel
Philadelphia, Pennsylvania, United States
Barcelona, , Spain
Aalborg, , Denmark
Montpellier, , France
Camperdown, , Australia
Málaga, , Spain
Zwijndrecht, , Netherlands
Jackson, Tennessee, United States
Apeldoorn, , Netherlands
Petach Tikva, , Israel
Napoli, , Italy
Witten, , Germany
Buenos Aires, , Argentina
Norfolk, Virginia, United States
Jerusalem, , Israel
Milano, , Italy
Gabrovo, , Bulgaria
Córdoba, , Spain
Esbjerg, , Denmark
Praha, , Czechia
Ostrava, , Czechia
Manchester, , United Kingdom
Amsterdam, , Netherlands
Ramat Gan, , Israel
Chattanooga, Tennessee, United States
Koeln, , Germany
North Miami Beach, Florida, United States
Bloemfontein, , South Africa
Louisville, Kentucky, United States
Tarzana, California, United States
Saint Leonards, New South Wales, Australia
Arnhem, , Netherlands
Haifa, , Israel
Stockholm, , Sweden
Bossier City, Louisiana, United States
Chicoutimi, Quebec, Canada
Columbus, Georgia, United States
Tarragona, , Spain
Barcelona, , Spain
łódź, , Poland
Konya, , Turkey
Lexington, Kentucky, United States
Cape Town, , South Africa
Haifa, , Israel
Las Vegas, Nevada, United States
Miami, Florida, United States
Hasselt, , Belgium
Saint Louis, Missouri, United States
Manassas, Virginia, United States
Kuala Lumpur, , Malaysia
Hradec Králové, , Czechia
Székesfehérvár, , Hungary
Hoogeveen, , Netherlands
Debrecen, , Hungary
Miami, Florida, United States
San Antonio, Texas, United States
Boca Raton, Florida, United States
Reẖovot, , Israel
Christchurch, , New Zealand
Dijon, , France
Houston, Texas, United States
Be'er Sheva, , Israel
Lampasas, Texas, United States
Flint, Michigan, United States
Orchard Park, New York, United States
Dimitrovgrad, , Bulgaria
Poznań, , Poland
Mangalore, , India
Lincoln, Nebraska, United States
Kansas City, Kansas, United States
Boston, Massachusetts, United States
Mesquite, Texas, United States
Sarnia, Ontario, Canada
Poole, , United Kingdom
Greenacres City, Florida, United States
Viborg, , Denmark
Charlotte, North Carolina, United States
Mckinney, Texas, United States
Cape Town, , South Africa
Lublin, , Poland
Rapid City, South Dakota, United States
Oak Brook, Illinois, United States
Ruse, , Bulgaria
Vénissieux, , France
Houston, Texas, United States
Porto, , Portugal
Los Angeles, California, United States
Woolloongabba, , Australia
Sofia, , Bulgaria
Baja, , Hungary
Kaunas, , Lithuania
Kaunas, , Lithuania
Morgantown, West Virginia, United States
Mesquite, Texas, United States
Edmond, Oklahoma, United States
Zamość, , Poland
New Taipei City, , Taiwan
Blackpool, , United Kingdom
Jaén, , Spain
Louny, , Czechia
Lisboa, , Portugal
Québec, Quebec, Canada
Tampa, Florida, United States
Prague, , Czechia
Nyíregyháza, , Hungary
Lublin, , Poland
Bron, , France
Carmel, Indiana, United States
Tampa, Florida, United States
Trinity, Florida, United States
Córdoba, , Argentina
Milano, , Italy
Smolyan, , Bulgaria
Brandýs Nad Labem, , Czechia
Tampa, Florida, United States
Columbus, Georgia, United States
Náchod, , Czechia
Paris, , France
Lenoir, North Carolina, United States
Málaga, , Spain
Sofia, , Bulgaria
Burgas, , Bulgaria
Haskovo, , Bulgaria
Ruse, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Dirksland, , Netherlands
Košice, , Slovakia
Columbus, Georgia, United States
Mexico City, , Mexico
Union City, New Jersey, United States
Greensboro, North Carolina, United States
Oslo, , Norway
La Coruna, , Spain
Varna, , Bulgaria
Toronto, Ontario, Canada
Cape Town, , South Africa
Ann Arbor, Michigan, United States
Teplice, , Czechia
Prague, , Czechia
Buenos Aires, , Argentina
Tarnów, , Poland
Baia Mare, , Romania
Veliko Tarnovo, , Bulgaria
Nyíregyháza, , Hungary
Auckland, , New Zealand
Sabadell, , Spain
Miramar, Florida, United States
Balatonfüred, , Hungary
Marseille, , France
Uherské Hradiště, , Czechia
Brezno, , Slovakia
Saint Herblain, , France
Ede, , Netherlands
Wrocław, , Poland
Göteborg, , Sweden
Sofia, , Bulgaria
Stara Zagora, , Bulgaria
Little River, South Carolina, United States
Mineola, New York, United States
Aarhus, , Denmark
Nijmegen, , Netherlands
Montréal, , Canada
Katowice, , Poland
Sulhiye, , Turkey
Hull, , United Kingdom
Huddersfield, England, United Kingdom
Brooklyn, New York, United States
Webster, Texas, United States
Rome, , Italy
Wellington, , New Zealand
Woodhurst, Chatsworth, United Kingdom
Bologna, , Italy
Mcallen, Texas, United States
Valenciennes, , France
Nyíregyháza, , Hungary
Aveiro, , Portugal
Rožňava, , Slovakia
Plovdiv, , Bulgaria
Svidník, , Slovakia
Trebišov, , Slovakia
Liskeard, , United Kingdom
Plovdiv, , Bulgaria
Stara Zagora, , Bulgaria
Příbram, , Czechia
Budapest, , Hungary
Chihuahua, , Mexico
Santa Maria Da Feira, , Portugal
Košice, , Slovakia
Lučenec, , Slovakia
Kaohsiung, , Taiwan
San Diego, California, United States
Plovdiv, , Bulgaria
Strasbourg, , France
Mexico City, , Mexico
Newquay, , United Kingdom
West Bromwich, , United Kingdom
Košice, , Slovakia
New York, New York, United States
Pulau Pinang, , Malaysia
Miskolc, , Hungary
Winston Salem, North Carolina, United States
Dresden, , Germany
Sliven, , Bulgaria
Sofia, , Bulgaria
Sofia, , Bulgaria
Blagoevgrad, , Bulgaria
Palmero, , Italy
Józefów, , Poland
Warsaw, , Poland
Svidník, , Slovakia
New York, New York, United States
Berlin, , Germany
Bergamo, , Italy
Taipei City, , Taiwan
Athens, , Greece
Praha, , Czechia
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Villa María, , Argentina
Campinas, , Brazil
Curitiba, , Brazil
Fortaleza, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Pazardzhik, , Bulgaria
Sofia, , Bulgaria
Toronto, , Canada
Klaipėda, , Lithuania
Gdańsk, , Poland
Lisboa, , Portugal
Bratislava, , Slovakia
İzmir, , Turkey
Caserta, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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