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

November 26, 2025 updated by: Ionis Pharmaceuticals, Inc.

An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

885

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1093AAS
        • Fundacion Favaloro
      • Buenos Aires, Argentina, C1061
        • CIPREC
      • Buenos Aires, Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei-Investigacion Clinica Aplicad
      • Buenos Aires, Argentina, C1430CKE
        • Glenny Corp SA
      • Córdoba, Argentina, X5003DCE
        • Instituto Médico DAMIC
      • Villa María, Argentina, X5900JKA
        • Clinica FUSAVIM Privada
  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Camperdown, Australia, 2050
        • Royal Prince Alfred Hospital
      • Clayton, Australia, 3168
        • Monash Medical Centre
      • Woolloongabba, Australia, 4102
        • Dr Heart Pty Ltd
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shore Hospital
  • Belgium
      • Brussels, Belgium, 1070
        • Universite Libre de Brussels (ULB)- Hopital Erasme
      • Hasselt, Belgium, 3500
        • Jessa Ziekenhuis
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven
  • Brazil
      • Campinas, Brazil, 13010-001
        • Centro Especializado em Cardiologia
      • Curitiba, Brazil, 80730-150
        • Núcleo de Pesquisa Clínica S/S
      • Fortaleza, Brazil, 60430-270
        • Hospital Universitario Walter Cantidio- UFC
      • Porto Alegre, Brazil, 90035-903
        • Nucleo de Pasquisa em Cirurgia Vascular
      • São Paulo, Brazil, 05403-000
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo- FMUSP
      • São Paulo, Brazil, CEP-05403-000
        • Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP
      • São Paulo, Brazil, SP-01228-00
        • CPQuali Pesquisa Clinica Ltda.
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • MHAT- Blagoevgrad AD
      • Burgas, Bulgaria, 8000
        • Medical Center Doctor Staykov EOOD
      • Dimitrovgrad, Bulgaria, 6400
        • Medical Center Diamedical 2013 OOD
      • Gabrovo, Bulgaria, 5300
        • MHAT
      • Haskovo, Bulgaria, 6300
        • MHAT Haskovo AD
      • Pazardzhik, Bulgaria, 4400
        • Multiprofile Hospital for Active Treament Pazardzhik, Cardiology Department
      • Plovdiv, Bulgaria, 4000
        • SBAL "Special Medic" Ltd.
      • Plovdiv, Bulgaria, 4001
        • UHMAT Kaspela Ltd
      • Plovdiv, Bulgaria, 4002
        • University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology
      • Rousse, Bulgaria, 7002
        • UMHAT Kanev AD
      • Rousse, Bulgaria, 7000
        • Medical Center Rusemed EOOD
      • Sliven, Bulgaria, 8800
        • DCC-1 Sliven Ltd.
      • Smolyan, Bulgaria, 4700
        • Medical center Smolyan clinical research OOD
      • Sofia, Bulgaria, 1680
        • Medical center Kalimat EOOD
      • Sofia, Bulgaria, 1797
        • UMHAT Sofiamed
      • Sofia, Bulgaria, 1000
        • Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD
      • Sofia, Bulgaria, 1700
        • MC Doctor Kalchev OOD
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Yoanna ISUL- Clinic of Cardiology
      • Sofia, Bulgaria, 1606
        • Medical Center Endomedical
      • Sofia, Bulgaria, 1784
        • Medical Centre Synexus Sofia
      • Sofia, Bulgaria, 8800
        • MHAT Silven to MMA Sofia
      • Stara Zagora, Bulgaria, 6003
        • Clinical of Cardiology
      • Stara Zagora, Bulgaria, 6010
        • Medical Center Zara-Med
      • Varna, Bulgaria, 9000
        • Diagnostic Consultative Center Equita (DCC Equita)
      • Varna, Bulgaria, 9020
        • Specialized Hospital for Active Treatment of Cardiology
      • Veliko Tarnovo, Bulgaria, 5006
        • Medical Centre "Nevromedics" EOOD
  • Canada
      • Montreal, Canada, H2W 1T7
        • Institut de recherches cliniques de Montréal
      • Toronto, Canada, M4C 3E7
        • Toronto General Hospital
    • Ontario
      • Sarnia, Ontario, Canada, N7T 4X3
        • Bluewater Clinical Research Group, Inc.
      • Toronto, Ontario, Canada, M3J2C5
        • Canadian Phase Onward Inc.
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Québec, Quebec, Canada, G1V 4W2
        • Clinique des Maladies Lipidiques de Quebec Inc.
  • Czechia
      • Brandýs nad Labem, Czechia, 250 01
        • Medicus Services s.r.o.
      • Hradec Králové, Czechia, 50005
        • University Hospital Hradec Kralove
      • Louny, Czechia, 440 01
        • KardioBusak s.r.o.
      • Náchod, Czechia, 547 01
        • Edumed s.r.o.
      • Ostrava, Czechia, 70852
        • Fakultni Nemocnice Ostrava
      • Prague, Czechia, 15006
        • Fakultni nemocnice v Motole
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice
      • Prague, Czechia, 19800
        • Endokrinologie Cerny Most s.r.o.
      • Prague, Czechia, 158 00
        • Praha Poliklinika Hurka
      • Příbram, Czechia, 261 01
        • MILAN KVAPIL s.r.o.
      • Teplice, Czechia, 415 01
        • AeskuLab k.s
      • Uherské Hradiště, Czechia, 686 01
        • MU Dr. Nina Zemkova s.r.o. Interni Ambulance
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Aarhus Universitet Hospital
      • Esbjerg, Denmark, 6700
        • Esbjerg Hospital
      • Viborg, Denmark, 8800
        • Viborg Regional Hospital
  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital
  • France
      • Bron, France, 69500
        • Louis Pradel Hospital
      • Dijon, France, 21079
        • CHU Dijon Bourgogne
      • Marseille, France, 13005
        • Hôpitaux de Marseille
      • Montpellier, France, 34295
        • Hopital Lapeyronie
      • Paris, France, 75013
        • AP-HP Hopital Pitie-Salpetriere
      • Saint-Herblain, France, 44093
        • CHU de Nantes - Hôpital Nord Laennec
      • Strasbourg, France, 67200
        • CHRU de Strasbourg
      • Valenciennes, France, 59300
        • Groupement de Cooperation Sanitaire (GCS) ESLAN - Polyclinique Vauban
      • Vénissieux, France, 69200
        • GHM les Portes du Sud
  • Germany
      • Berlin, Germany, 13353
        • Charite- Universitaetsmedizin Berlin
      • Cologne, Germany, 50937
        • Universitaetsklinikum Koeln
      • Dresden, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus
      • Witten, Germany, 58455
        • Forschungszentrum Ruhr
  • Greece
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Athens, Greece, 106 76
        • Evangelismos General Hospital Athens
  • Hungary
      • Baja, Hungary, 6500
        • Lausmed Kft
      • Balatonfüred, Hungary, 8230
        • DRC Gyógyszervizsgáló Központ Korlátolt felelősségű társaság Balatonfüred
      • Budapest, Hungary, H-1063
        • Obudai Egeszsegugyyi Centrum
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Hungary, H-3529
        • Rakoczi Ferenc Korhaz
      • Nyíregyháza, Hungary, 4405
        • Dr. Vasas Szilard Haziorvosi Rendelo
      • Nyíregyháza, Hungary, H-4400
        • Kardiologia Szakrendeles
      • Székesfehérvár, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
  • India
      • Mangalore, India, 575003
        • Vinaya Hospital and Research Centre
      • New Delhi, India, 110060
        • Sir Ganga Ram Hospital
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3436212
        • The Lady Davis Carmel Medical Center
      • Haifa, Israel, 3104802
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 52621
        • The Chaim Sheba Medical Center
      • Rehovot, Israel, 76100
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXII
      • Bologna, Italy, 40138
        • Policlinico di Sant'Orsola
      • Caserta, Italy, 81100
        • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Sant' Anna e San Sebastiano" di Caserta
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda
      • Milan, Italy, 20092
        • Ospdale E. Bassini
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Palmero, Italy, 90127
        • Azienda Ospedaliera Universitaria Policlinico
      • Rome, Italy, 00161
        • Department of Translational and Precision Medicine
  • Lithuania
      • Kaunas, Lithuania, 49387
        • Klinikiniai sprendimai, UAB
      • Kaunas, Lithuania, 49456
        • Saules Seimos Medicinos Centras
      • Klaipėda, Lithuania, 91131
        • Kardiologijos ir reabilitacijos klinika, UAB
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre (UMMC)
      • Pulau Pinang, Malaysia, 10990
        • Pulau Pinang Hospital
  • Mexico
      • Chihuahua City, Mexico, 31207
        • Scientia Investigacion Clinical Sc
      • Mexico City, Mexico, 06700
        • Clinstile, S.A. de C.V.
      • Mexico City, Mexico, 20230
        • Centro de Investigacion Cardiometabolica S.C.
  • Netherlands
      • Amsterdam, Netherlands, 1105AZ
        • Academic Medical Center
      • Apeldoorn, Netherlands, 7334 DZ
        • Gelre Ziekenhuizen
      • Arnhem, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate
      • Dirksland, Netherlands, 3247 BW
        • Het Van Weel-Bethesda Ziekenhuis
      • Ede, Netherlands, 1001-5000
        • Ziekenhuis Gelderse Vallei
      • Hoogeveen, Netherlands, 7909 AA
        • Bethesda Diabetes Research Center
      • Nijmegen, Netherlands, 6525 EX
        • Radboud UMC
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Zwijndrecht, Netherlands, 3331 LZ
        • Albert Schweitzer ziekenhuis
  • New Zealand
      • Auckland, New Zealand, 8011
        • New Zealand Clinical Research
      • Wellington, New Zealand, 6021
        • Edgar Diabetes and Obesity Research Centre
  • Norway
      • Oslo, Norway, 424
        • The Lipid Clinic (Oslo University Hospital)
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersytecki Centrum Kliniczne, I Klinika Kardiologii
      • Józefów, Poland, 05-410
        • Biokinetica Spolka Akcujna
      • Katowice, Poland, 40-772
        • Centrum Medyczne Salvia
      • Lodz, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki
      • Lublin, Poland, 20-412
        • ETG Lublin
      • Lublin, Poland, 20-078
        • Clinical Best Solutions
      • Poznan, Poland, 60-589
        • Centrum Zdrowia Metabolicznego Pawel Bogdanski
      • Tarnów, Poland, 33-100
        • Osrodek Badan Klinicznych Metabolica
      • Warsaw, Poland, 02-793
        • Clinical Best Solutions Sp. z.o.o. Spolka Komandytowa
      • Wroclaw, Poland, 50-088
        • Przychodnia FutureMeds Wroclaw
      • Zamość, Poland, 22-400
        • ETG Zamość
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Hospital Infante D. Pedro
      • Lisbon, Portugal, 1350-352
        • Hospital CUF Tejo
      • Lisbon, Portugal, 1350-352
        • Hospital COF Tejo
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitario de Sao Joao
      • Santa Maria da Feira, Portugal, 4520-211
        • Centro Hospitalar de Entre o Douro e Vouga, E.P.E.
  • Romania
      • Baia Mare, Romania, 430123
        • Cardioplus Center SRL
  • Slovakia
      • Bratislava, Slovakia, 831 06
        • Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
      • Brezno, Slovakia, 97701
        • Kardiologicka ambulancia
      • Košice, Slovakia, 040 22
        • Cardio D&R, S.R.O. Kosice
      • Košice, Slovakia, 04001
        • Human-Care s.r.o.
      • Košice, Slovakia, 04011
        • Vychodoslovensky Utsav srdcovych a cievnych chorob a.s.
      • Lučenec, Slovakia, 984 01
        • Interna a diabetologicka ambulancia- IN- DRA- s.r.o.
      • Rožňava, Slovakia, 048 01
        • DIAB sro
      • Svidník, Slovakia, 08901
        • Interna SK, s.r.o., Kardiologicka a interna ambulancia
      • Svidník, Slovakia, 08901
        • Nemocnica arm. generala L. Svobodu Svidnik, a.s
      • Trebišov, Slovakia, 075 01
        • Areteus sro
  • South Africa
      • Bloemfontein, South Africa, 9301
        • Latros International
      • Cape Town, South Africa, 7700
        • University of Cape Town
      • Cape Town, South Africa, 7500
        • TREAD Research
      • Cape Town, South Africa, 7130
        • Medi Clinic Vergelegen
  • Spain
      • A Coruña, Spain, 15001
        • Hospital Abente y Lago
      • Badalona, Spain, 08916
        • Hospital Germans Trías i Pujol
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 8907
        • Hospital Universitari de Bellvitge
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Jaén, Spain, 23007
        • Hospital Universitario de Jaén
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Sabadell, Spain, 08208
        • Corporacio Sanitaria Parc Tauli- Hospital de Sabadell
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41013
        • Hospital Virgen Del Rocio
      • Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska, University Hospital
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital Huddinge
  • Taiwan
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Ching-Ho Memorial Hospital
      • New Taipei City, Taiwan, 25160
        • Mackay Memorial Hospital
      • Taichung, Taiwan, 40705
        • Taichung Veterans General Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 111
        • Shing Kong Wu Ho-Su Memorial Hospital
  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35040
        • Ege University School of Medicine, Department of Cardiology
      • Konya, Turkey (Türkiye), 42080
        • Necmettin Erbakan Universitesi Meram Tip Fakultesi
      • Sulhiye, Turkey (Türkiye), 06100
        • Hacettepe Üniversitesi Tıp Fakültesi
  • United Kingdom
      • Blackpool, United Kingdom, FY4 3AD
        • Waterloo Medical Care
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmiry
      • Liskeard, United Kingdom, PL14 3XA
        • Oak Tree Surgery and Pensilva Health Centre
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust
      • Newquay, United Kingdom, TR7 1RQ
        • Newquay Health Centre
      • Poole, United Kingdom, BH16 5PW
        • The Adam Practice
      • West Bromwich, United Kingdom, B71 4HU
        • Sandwell and West Birmingham NHS Trust
    • Chatsworth
      • Woodhurst, Chatsworth, United Kingdom, 4092
        • Centre for Diabetes, Endocrinology and Metabolic Disease
    • England
      • Huddersfield, England, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
  • United States
    • California
      • Los Angeles, California, United States, 90057
        • LA Universal Research Center, Inc.
      • San Diego, California, United States, 92161
        • University of California, San Diego (UCSD)
      • Tarzana, California, United States, 91356
        • Metabolic Institute of America
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Greenacres City, Florida, United States, 33467
        • Finlay Medical Research
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services, LLC
      • Miramar, Florida, United States, 33027
        • Innovia Research Center, Inc.
      • North Miami Beach, Florida, United States, 33162
        • Harmony Clinical Research, Inc.
      • Tampa, Florida, United States, 33634
        • JSV Clinical Research Study, Inc.
      • Tampa, Florida, United States, 33614
        • R & B Medical Center LLC
      • Tampa, Florida, United States, 33615
        • VICIS Clinical Research
      • Trinity, Florida, United States, 34655
        • Bayside Clinical Research
    • Georgia
      • Columbus, Georgia, United States, 31904
        • IACT Health
      • Columbus, Georgia, United States, 31904
        • Centricity Research
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Affinity Health
    • Indiana
      • Carmel, Indiana, United States, 46290
        • St. Vincent Medical Group, Inc.
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center (KUMC)
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • The Research Group of Lexington, LLC
      • Louisville, Kentucky, United States, 40213
        • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Grace Research, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine
      • Towson, Maryland, United States, 21204
        • IRC Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Heart Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan- Endocrinology & Metabolism
      • Flint, Michigan, United States, 48504
        • Aa Mrc, Llc
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Palm Research Center, Inc.
    • New Jersey
      • Union City, New Jersey, United States, 07087
        • Hudson County Clinical Trials Research Center
    • New York
      • Brooklyn, New York, United States, 33709
        • Modern Medical
      • Mineola, New York, United States, 11501
        • NYU Langone Health
      • New York, New York, United States, 10016
        • Langone Medical Center
      • New York, New York, United States, 10032
        • Vagelos College of Physicians and Surgeons of Columbia University
      • Orchard Park, New York, United States, 14127
        • Orchard Park Family Practice
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute
      • Greensboro, North Carolina, United States, 27401
        • Kenneth Hilty
      • Lenoir, North Carolina, United States, 28645
        • Clinical Trials of America, LLC
      • Winston-Salem, North Carolina, United States, 27103
        • Lexington
    • Ohio
      • Columbus, Ohio, United States, 43203
        • The Ohio State University
    • Oklahoma
      • Edmond, Oklahoma, United States, 73034
        • Central Oklahoma Early Detection Center
      • Tulsa, Oklahoma, United States, 74104
        • Oklahoma Heart Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19014
        • University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Little River, South Carolina, United States, 29566
        • Walker Family Care
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
      • Rapid City, South Dakota, United States, 57701
        • Monument Health Clinical Research
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Research & Medicine, PLLC
      • Jackson, Tennessee, United States, 38301
        • The Jackson Clinic
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77040
        • Juno Research
      • Houston, Texas, United States, 77099
        • Pioneer Research Solutions
      • Kerrville, Texas, United States, 78028
        • Sante Clinical Research LLC
      • Lampasas, Texas, United States, 76550
        • FMC Science
      • McAllen, Texas, United States, 78503
        • DCT- McAllen Primary Care, LLC
      • McKinney, Texas, United States, 75071
        • Texas Institute of Cardiology
      • Mesquite, Texas, United States, 75149
        • Southern Endocrinology Associates
      • Mesquite, Texas, United States, 75149
        • SMS Clinical Research, LLC
      • Odessa, Texas, United States, 79761
        • Permian Research Foundation
      • San Antonio, Texas, United States, 78229
        • Diabetes & Glandular Disease Clinic, P.A.
      • Webster, Texas, United States, 77598
        • Tranquil Clinical and Research Consulting Services
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research
      • Norfolk, Virginia, United States, 23510
        • York Clinical Research
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • WVU Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Olezarsen
Administered as SC injection.
Other Names:
  • ISIS 678354
  • AKCEA-APOCIII-LRx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Baseline up to Week 157
Baseline up to Week 157
Proportion of Participants Who Experience Adverse Events (AEs)
Time Frame: Baseline up to Week 157
Baseline up to Week 157
Proportion of Participants Who Use Concomitant Medications
Time Frame: Baseline up to Week 157
Baseline up to Week 157

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 25, 2022

First Submitted That Met QC Criteria

December 25, 2022

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 678354-CS15
  • 2022-501999-26-00 (Other Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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