CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)
- Registration Number
- NCT05681351
- Lead Sponsor
- Ionis Pharmaceuticals, Inc.
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.
- Detailed Description
This is a multi-center, open-label extension (OLE) study of approximately 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 157-week treatment period. The study will include a 31-day qualification Period, a 157-week treatment period, and a 13-week post-treatment period.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 800
- 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
• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Olezarsen Olezarsen Participants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 153.
- Primary Outcome Measures
Name Time Method Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157 Baseline up to Week 157 Proportion of Participants Who Experience Adverse Events (AEs) Baseline up to Week 157 Proportion of Participants Who Use Concomitant Medications Baseline up to Week 157
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (254)
Hospital Universitario de Jaen
🇪🇸Jaén, Spain
Hospital Abente y Lago
🇪🇸La Coruna, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
SBAL "Special Medic" Ltd.
🇧🇬Plovdiv, Bulgaria
UHMAT Kaspela Ltd
🇧🇬Plovdiv, Bulgaria
Evangelismos General Hospital Athens
🇬🇷Athens, Greece
Hygeia Hospital
🇬🇷Athens, Greece
Lausmed Kft
🇭🇺Baja, Hungary
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 Carl Gustav Carus
🇩🇪Dresden, Germany
Universitaetsklinikum Koeln
🇩🇪Koeln, Germany
Forschungszentrum Ruhr
🇩🇪Witten, Germany
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
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 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 Virgen de la Victoria
🇪🇸Málaga, Spain
Corporacio Sanitaria Parc Tauli- Hospital de Sabadell
🇪🇸Sabadell, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, 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
🇸🇪Göteborg, Sweden
Karolinska University Hospital Huddinge
🇸🇪Stockholm, Sweden
DCC-1 Sliven Ltd.
🇧🇬Sliven, Bulgaria
Medical Center Smolyan Clinical Research OOD
🇧🇬Smolyan, Bulgaria
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
🇺🇸Miami, Florida, United States
Columbus Clinical Services, LLC
🇺🇸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
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
🇺🇸Saint 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
Clinical of Cardiology
🇧🇬Stara Zagora, Bulgaria
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Juno Research
🇺🇸Houston, Texas, United States
Pioneer Research Solutions
🇺🇸Houston, 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
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
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
University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology
🇧🇬Plovdiv, Bulgaria
Medical Center Rusemed EOOD
🇧🇬Ruse, Bulgaria
UMHAT Kanev AD
🇧🇬Ruse, Bulgaria
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
🇧🇬Sofia, Bulgaria
Praha Poliklinika Hurka
🇨🇿Praha, Czechia
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
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
🇨🇦Montréal, 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
Endokrinologie Cerny Most s.r.o.
🇨🇿Prague, Czechia
Fakultni Nemocnice v Motole
🇨🇿Praha, Czechia
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
🇭🇺Székesfehérvár, Hungary
Vinaya Hospital and Research Centre
🇮🇳Mangalore, India
Soroka Medical Center
🇮🇱Be'er Sheva, Israel
Bnai Zion Medical Center
🇮🇱Haifa, Israel
The Lady Davis Carmel Medical Center
🇮🇱Haifa, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Israel
Rabin Medical Center
🇮🇱Petach Tikva, Israel
The Chaim Sheba Medical Center
🇮🇱Ramat Gan, Israel
Kaplan Medical Center
🇮🇱Reẖovot, 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
🇮🇹Milano, Italy
Asst Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Federico II
🇮🇹Napoli, 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, 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
🇵🇱Gdańsk, Poland
Biokinetica Spolka Akcujna
🇵🇱Józefów, Poland
Centrum Medyczne Salvia
🇵🇱Katowice, Poland
Clinical Best Solutions
🇵🇱Lublin, Poland
ETG Lublin
🇵🇱Lublin, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski
🇵🇱Poznań, Poland
Osrodek Badan Klinicznych Metabolica
🇵🇱Tarnów, Poland
Clinical Best Solutions Sp. z.o.o. Spolka Komandytowa
🇵🇱Warsaw, Poland
Przychodnia Futuremeds Wroclaw
🇵🇱Wrocław, Poland
ETG Zamosc
🇵🇱Zamość, Poland
Instytut Centrum Zdrowia Matki Polki
🇵🇱Łódź, Poland
Hospital Infante D. Pedro
🇵🇹Aveiro, Portugal
Hospital COF Tejo
🇵🇹Lisboa, Portugal
Hospital CUF Tejo
🇵🇹Lisboa, 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
Kaohsiung Medical University Ching-Ho Memorial Hospital
🇨🇳Kaohsiung, 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 City, Taiwan
Ege University School of Medicine, Department of Cardiology
🇹🇷İzmir, Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi
🇹🇷Konya, Turkey
Hacettepe Üniversitesi Tıp Fakültesi
🇹🇷Sulhiye, Turkey
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