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CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
Sponsor: Ionis Pharmaceuticals, Inc.
Summary
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
Official title: An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
885
Start Date
2022-12-13
Completion Date
2027-03
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
Olezarsen
Administered as SC injection.
Locations (262)
LA Universal Research Center, Inc.
Los Angeles, California, United States
University of California, San Diego (UCSD)
San Diego, California, United States
Metabolic Institute of America
Tarzana, California, United States
Excel Medical Clinical Trials
Boca Raton, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
Columbus Clinical Services, LLC
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Innovia Research Center, Inc.
Miramar, Florida, United States
Harmony Clinical Research, Inc.
North Miami Beach, Florida, United States
R & B Medical Center LLC
Tampa, Florida, United States
VICIS Clinical Research
Tampa, Florida, United States
JSV Clinical Research Study, Inc.
Tampa, Florida, United States
Bayside Clinical Research
Trinity, Florida, United States
Centricity Research
Columbus, Georgia, United States
IACT Health
Columbus, Georgia, United States
Affinity Health
Oak Brook, Illinois, United States
St. Vincent Medical Group, Inc.
Carmel, Indiana, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
Grace Research, LLC
Bossier City, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
IRC Clinics
Towson, Maryland, United States
Massachusetts General Hospital Heart Center
Boston, Massachusetts, United States
University of Michigan- Endocrinology & Metabolism
Ann Arbor, Michigan, United States
Aa Mrc, Llc
Flint, Michigan, United States
Washington School of Medicine
St Louis, Missouri, United States
Bryan Medical Center
Lincoln, Nebraska, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Hudson County Clinical Trials Research Center
Union City, New Jersey, United States
Modern Medical
Brooklyn, New York, United States
NYU Langone Health
Mineola, New York, United States
Langone Medical Center
New York, New York, United States
Vagelos College of Physicians and Surgeons of Columbia University
New York, New York, United States
Orchard Park Family Practice
Orchard Park, New York, United States
The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States
Kenneth Hilty
Greensboro, North Carolina, United States
Clinical Trials of America, LLC
Lenoir, North Carolina, United States
Lexington
Winston-Salem, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Central Oklahoma Early Detection Center
Edmond, Oklahoma, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Walker Family Care
Little River, South Carolina, United States
Monument Health Clinical Research
Rapid City, South Dakota, United States
Health Concepts
Rapid City, South Dakota, United States
Chattanooga Research & Medicine, PLLC
Chattanooga, Tennessee, United States
The Jackson Clinic
Jackson, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Juno Research
Houston, Texas, United States
Pioneer Research Solutions
Houston, Texas, United States
Sante Clinical Research LLC
Kerrville, Texas, United States
FMC Science
Lampasas, Texas, United States
DCT- McAllen Primary Care, LLC
McAllen, Texas, United States
Texas Institute of Cardiology
McKinney, Texas, United States
SMS Clinical Research, LLC
Mesquite, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
Permian Research Foundation
Odessa, Texas, United States
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, United States
Tranquil Clinical and Research Consulting Services
Webster, Texas, United States
Manassas Clinical Research
Manassas, Virginia, United States
York Clinical Research
Norfolk, Virginia, United States
WVU Heart and Vascular Institute
Morgantown, West Virginia, United States
CIPREC
Buenos Aires, Argentina
Fundacion Favaloro
Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei-Investigacion Clinica Aplicad
Buenos Aires, Argentina
Glenny Corp SA
Buenos Aires, Argentina
Instituto Medico DAMIC
Córdoba, Argentina
Clinica FUSAVIM Privada
Villa María, Argentina
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, Australia
Royal Prince Alfred Hospital
Camperdown, Australia
Monash Medical Centre
Clayton, Australia
Dr Heart Pty Ltd
Woolloongabba, Australia
Universite Libre de Brussels (ULB)- Hopital Erasme
Brussels, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium
Centro Especializado em Cardiologia
Campinas, Brazil
Nucleo de Pesquisa Clinica S/S
Curitiba, Brazil
Hospital Universitario Walter Cantidio- UFC
Fortaleza, Brazil
Nucleo de Pasquisa em Cirurgia Vascular
Porto Alegre, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- FMUSP
São Paulo, Brazil
Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
São Paulo, Brazil
CPQuali Pesquisa Clinica Ltda.
São Paulo, Brazil
MHAT- Blagoevgrad AD
Blagoevgrad, Bulgaria
Medical Center Doctor Staykov EOOD
Burgas, Bulgaria
Medical Center Diamedical 2013 OOD
Dimitrovgrad, Bulgaria
MHAT
Gabrovo, Bulgaria
MHAT Haskovo AD
Haskovo, Bulgaria
Multiprofile Hospital for Active Treament Pazardzhik, Cardiology Department
Pazardzhik, Bulgaria
SBAL "Special Medic" Ltd.
Plovdiv, Bulgaria
UHMAT Kaspela Ltd
Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology
Plovdiv, Bulgaria
Medical Center Rusemed EOOD
Rousse, Bulgaria
UMHAT Kanev AD
Rousse, Bulgaria
DCC-1 Sliven Ltd.
Sliven, Bulgaria
Medical Center Smolyan Clinical Research OOD
Smolyan, Bulgaria
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
Sofia, Bulgaria
UMHAT Tsaritsa Yoanna ISUL- Clinic of Cardiology
Sofia, Bulgaria
Medical Center Endomedical
Sofia, Bulgaria
Medical Center Kalimat EOOD
Sofia, Bulgaria
MC Doctor Kalchev OOD
Sofia, Bulgaria
Medical Centre Synexus Sofia
Sofia, Bulgaria
UMHAT Sofiamed
Sofia, Bulgaria
MHAT Silven to MMA Sofia
Sofia, Bulgaria
Clinical of Cardiology
Stara Zagora, Bulgaria
Medical Center Zara-Med
Stara Zagora, Bulgaria
Diagnostic Consultative Center Equita (DCC Equita)
Varna, Bulgaria
Specialized Hospital for Active Treatment of Cardiology
Varna, Bulgaria
Medical Centre "Nevromedics" EOOD
Veliko Tarnovo, Bulgaria
Bluewater Clinical Research Group, Inc.
Sarnia, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, Quebec, Canada
Institut de Recherches Cliniques de Montreal
Montreal, Canada
Toronto General Hospital
Toronto, Canada
MEDICUS SERVICES s.r.o.
Brandýs nad Labem, Czechia
University Hospital Hradec Králové
Hradec Králové, Czechia
KardioBusak s.r.o.
Louny, Czechia
EDUMED s.r.o.
Náchod, Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia
Vseobecna fakultni nemocnice
Prague, Czechia
Fakultni Nemocnice v Motole
Prague, Czechia
Praha Poliklinika Hurka
Prague, Czechia
Endokrinologie Cerny Most s.r.o.
Prague, Czechia
Milan Kvapil s.r.o.
Příbram, Czechia
AeskuLab k.s
Teplice, Czechia
MU Dr. Nina Zemkova s.r.o. Interni Ambulance
Uherské Hradiště, Czechia
Aalborg University Hospital
Aalborg, Denmark
Aarhus Universitet Hospital
Aarhus, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Viborg Regional Hospital
Viborg, Denmark
Turku University Hospital
Turku, Finland
Louis Pradel Hospital
Bron, France
Chu Dijon Bourgogne
Dijon, France
Hôpitaux de Marseille
Marseille, France
Hopital Lapeyronie
Montpellier, France
AP-HP Hopital Pitie-Salpetriere
Paris, France
CHU de Nantes - Hôpital Nord Laennec
Saint-Herblain, France
CHRU de Strasbourg
Strasbourg, France
Groupement de Cooperation Sanitaire (GCS) ESLAN - Polyclinique Vauban
Valenciennes, France
GHM les Portes du Sud
Vénissieux, France
Charite- Universitaetsmedizin Berlin
Berlin, Germany
Universitaetsklinikum Koeln
Cologne, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, Germany
Forschungszentrum Ruhr
Witten, Germany
Evangelismos General Hospital Athens
Athens, Greece
Hygeia Hospital
Athens, Greece
Lausmed Kft
Baja, Hungary
DRC Gyógyszervizsgáló Központ Korlátolt felelősségű társaság Balatonfüred
Balatonfüred, Hungary
Obudai Egeszsegugyyi Centrum
Budapest, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary
Rakoczi Ferenc Korhaz
Miskolc, Hungary
Dr. Vasas Szilard Haziorvosi Rendelo
Nyíregyháza, Hungary
Kardiologia Szakrendeles
Nyíregyháza, Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, Hungary
Vinaya Hospital and Research Centre
Mangalore, India
Sir Ganga Ram Hospital
New Delhi, India
Soroka Medical Center
Beersheba, Israel
Bnai Zion Medical Center
Haifa, Israel
The Lady Davis Carmel Medical Center
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
The Chaim Sheba Medical Center
Ramat Gan, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Azienda Socio Sanitaria Territoriale Papa Giovanni XXII
Bergamo, Italy
Policlinico di Sant'Orsola
Bologna, Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Sant' Anna e San Sebastiano" di Caserta
Caserta, Italy
Ospdale E. Bassini
Milan, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Italy
Azienda Ospedaliera Universitaria Federico II
Naples, Italy
Azienda Ospedaliera Universitaria Policlinico
Palmero, Italy
Department of Translational and Precision Medicine
Rome, Italy
Klinikiniai Sprendimai, UAB
Kaunas, Lithuania
Saules Seimos Medicinos Centras
Kaunas, Lithuania
Kardiologijos ir reabilitacijos klinika, UAB
Klaipėda, Lithuania
University Malaya Medical Centre (UMMC)
Kuala Lumpur, Malaysia
Pulau Pinang Hospital
Pulau Pinang, Malaysia
Scientia Investigacion Clinical Sc
Chihuahua City, Mexico
Clinstile, S.A. de C.V.
Mexico City, Mexico
Centro de Investigacion Cardiometabolica S.C.
Mexico City, Mexico
Academic Medical Center
Amsterdam, Netherlands
Gelre Ziekenhuizen
Apeldoorn, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
Het Van Weel-Bethesda Ziekenhuis
Dirksland, Netherlands
Ziekenhuis Gelderse Vallei
Ede, Netherlands
Bethesda Diabetes Research Center
Hoogeveen, Netherlands
Radboud UMC
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Albert Schweitzer Ziekenhuis
Zwijndrecht, Netherlands
New Zealand Clinical Research
Auckland, New Zealand
Edgar Diabetes and Obesity Research Centre
Wellington, New Zealand
The Lipid Clinic (Oslo University Hospital)
Oslo, Norway
Uniwersytecki Centrum Kliniczne, I Klinika Kardiologii
Gdansk, Poland
Biokinetica Spolka Akcujna
Józefów, Poland
Centrum Medyczne Salvia
Katowice, Poland
Instytut Centrum Zdrowia Matki Polki
Lodz, Poland
Clinical Best Solutions
Lublin, Poland
ETG Lublin
Lublin, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, Poland
Osrodek Badan Klinicznych Metabolica
Tarnów, Poland
Clinical Best Solutions Sp. z.o.o. Spolka Komandytowa
Warsaw, Poland
Przychodnia Futuremeds Wroclaw
Wroclaw, Poland
ETG Zamosc
Zamość, Poland
Hospital Infante D. Pedro
Aveiro, Portugal
Hospital COF Tejo
Lisbon, Portugal
Hospital CUF Tejo
Lisbon, Portugal
Centro Hospitalar Universitario De Sao Joao
Porto, Portugal
Centro Hospitalar de Entre o Douro e Vouga, E.P.E.
Santa Maria da Feira, Portugal
Cardioplus Center SRL
Baia Mare, Romania
Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
Bratislava, Slovakia
Kardiologická ambulancia
Brezno, Slovakia
Cardio D&R, S.R.O. Kosice
Košice, Slovakia
Human-Care s.r.o.
Košice, Slovakia
Vychodoslovensky Utsav srdcovych a cievnych chorob a.s.
Košice, Slovakia
Interna a diabetologicka ambulancia- IN- DRA- s.r.o.
Lučenec, Slovakia
Diab sro
Rožňava, Slovakia
Interna SK, s.r.o., Kardiologicka a interna ambulancia
Svidník, Slovakia
Nemocnica arm. generala L. Svobodu Svidnik, a.s
Svidník, Slovakia
Areteus sro
Trebišov, Slovakia
Latros International
Bloemfontein, South Africa
Medi Clinic Vergelegen
Cape Town, South Africa
TREAD Research
Cape Town, South Africa
University of Cape Town
Cape Town, South Africa
Hospital Abente y Lago
A Coruña, Spain
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinic De Barcelona
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
Hospital Universitario de Jaen
Jaén, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Spain
Corporacio Sanitaria Parc Tauli- Hospital de Sabadell
Sabadell, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Virgen del Rocío
Seville, Spain
Hospital Universitari Sant Joan de Reus
Tarragona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Sahlgrenska, University Hospital
Gothenburg, Sweden
Karolinska University Hospital Huddinge
Stockholm, Sweden
Kaohsiung Medical University Ching-Ho Memorial Hospital
Kaohsiung City, Taiwan
Mackay Memorial Hospital
New Taipei City, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Shing Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Ege University School of Medicine, Department of Cardiology
Izmir, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi
Konya, Turkey (Türkiye)
Hacettepe Üniversitesi Tıp Fakültesi
Sulhiye, Turkey (Türkiye)
Centre for Diabetes, Endocrinology and Metabolic Disease
Woodhurst, Chatsworth, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, England, United Kingdom
Waterloo Medical Care
Blackpool, United Kingdom
Hull Royal Infirmiry
Hull, United Kingdom
Oak Tree Surgery and Pensilva Health Centre
Liskeard, United Kingdom
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Newquay Health Centre
Newquay, United Kingdom
The Adam Practice
Poole, United Kingdom
Sandwell and West Birmingham NHS Trust
West Bromwich, United Kingdom