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ACTIVE NOT RECRUITING
NCT05681351
PHASE3

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

Sponsor: Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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