A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Last updated: January 27, 2025
Sponsor: Ionis Pharmaceuticals, Inc.
Overall Status: Active - Not Recruiting

Phase

3

Condition

Hypertriglyceridemia

Treatment

Olezarsen

Placebo

Clinical Study ID

NCT05079919
ISIS 678354-CS5
2024-510696-38-00
2021-002192-19
  • Ages > 18
  • All Genders

Study Summary

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification

  • Patients must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized andstabilized for at least 4 weeks prior to Screening to minimize changes in thesemedications during the study.

Exclusion

Key Exclusion Criteria:

  • Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening

  • Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal

  • Total bilirubin > upper limit of normal unless due to Gilbert's syndrome

  • Estimated GFR < 30 mL/min/1.73 m^2

Study Design

Total Participants: 617
Treatment Group(s): 2
Primary Treatment: Olezarsen
Phase: 3
Study Start date:
October 25, 2021
Estimated Completion Date:
July 31, 2025

Study Description

This is a multi-center, randomized, double-blind, placebo-controlled study in 617 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

Connect with a study center

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Royal North Shoe Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Dr. Heart Pty Ltd at Cholesterol Care Australia

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton S., Victoria 3168
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, 5000
    Australia

    Site Not Available

  • MHAT Blagoevgrad AD

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • Medical Center Doctor Staykov EOOD

    Burgas, 8008
    Bulgaria

    Site Not Available

  • Medical Center Diamedical 2013 OOD

    Dimitrovgrad, 6400
    Bulgaria

    Site Not Available

  • MHAT "Dr. Tota Venkova" AD

    Gabrovo, 5300
    Bulgaria

    Site Not Available

  • Medical Center "Hera" EOOD

    Montana, 3400
    Bulgaria

    Site Not Available

  • SHAT "Special Medic" Ltd

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Medical Center Rusemed EOOD

    Ruse, 7000
    Bulgaria

    Site Not Available

  • DCC 1 Sliven

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Gabriela Zhelyazkova

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Medical Center Smolyan Clinical Research OOD

    Smolyan, 4700
    Bulgaria

    Site Not Available

  • MC Doctor Kalchev OOD

    Sofia, 1700
    Bulgaria

    Site Not Available

  • Medical Centar "KALIMAT"

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Medical Center Endomedical EOOD

    Sofia, 1606
    Bulgaria

    Site Not Available

  • UMHAT Sofiamed OOD

    Sofia, 1797
    Bulgaria

    Site Not Available

  • New Rehabilitation Center

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • UMHAT Prof. Dr. Stoyan Kirkovich AD, Clinic of Cardiology

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Medical Centre Nevromedics EOOD

    Veliko Tarnovo, 5006
    Bulgaria

    Site Not Available

  • Arc Biosystems

    Vancouver, British Columbia V6Z 2C7
    Canada

    Site Not Available

  • Canadian Phase Onward Inc

    Toronto, Ontario M3J 0K2
    Canada

    Site Not Available

  • Ecogene-21

    Chicoutimi, Quebec G7H 7K9
    Canada

    Site Not Available

  • Institut de recherches cliniques de Montréal (IRCM)

    Montréal, Quebec H2W 1R7
    Canada

    Site Not Available

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec G1V 4W2
    Canada

    Site Not Available

  • MEDICUS SERVICES s.r.o.

    Brandýs Nad Labem, 250 01
    Czechia

    Site Not Available

  • EDUMED s.r.o.

    Hradec Králové, 500 02
    Czechia

    Site Not Available

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500-05
    Czechia

    Site Not Available

  • EDUMED s.r.o.

    Náchod, 547 01
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava, 70852
    Czechia

    Site Not Available

  • Lekarna Poliklinika Hurka

    Prague, 15800
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice

    Prague, 128 08
    Czechia

    Site Not Available

  • Interni Ambulance

    Uherské Hradiště, 686 01
    Czechia

    Site Not Available

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Esbjerg Hospital

    Esbjerg, 6700
    Denmark

    Site Not Available

  • Bispebjerg Hospital

    Frederiksberg, 2000
    Denmark

    Site Not Available

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Site Not Available

  • Godstrup Regional Hospital

    Herning, 7400
    Denmark

    Site Not Available

  • Regionshospitalet Viborg

    Viborg, 8800
    Denmark

    Site Not Available

  • Turku University Hospital

    Turku, 20520
    Finland

    Site Not Available

  • Ylitornio Health Care Center

    Ylitornio, 95600
    Finland

    Site Not Available

  • Hôpital Louis Pradel

    Bron, 69677
    France

    Site Not Available

  • CHU Dijon Bourgogne

    Dijon, 21079
    France

    Site Not Available

  • Hopital de la Conception

    Marseille, 13005
    France

    Site Not Available

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Pitie Salpetriere APHP

    Paris, 75013
    France

    Site Not Available

  • CHU Nantes - Hopital Nord Laennec

    Saint-Herblain, 44093
    France

    Site Not Available

  • Stoffwechselcentrum Charite Campus Virchow

    Berlin, 13353
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 1307
    Germany

    Site Not Available

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253
    Germany

    Site Not Available

  • Klinische Forschung Hannover-Mitte GmbH

    Hannover, 30159
    Germany

    Site Not Available

  • St. Josefskrankenhaus,

    Heidelberg, 69115
    Germany

    Site Not Available

  • Uniklinik Köln

    Köln, 50937
    Germany

    Site Not Available

  • Praxis Dr. med. Taggeselle

    Markkleeberg, 04416
    Germany

    Site Not Available

  • Kardiologische Praxis in Papenburg

    Papenburg, 26871
    Germany

    Site Not Available

  • Evangelisches Krankenhaus Witten

    Witten, 58455
    Germany

    Site Not Available

  • BKS Research Kft

    Hatvan, Heves 3000
    Hungary

    Site Not Available

  • Medifarma 98 Kft

    Nyíregyháza, Szabolcs-Szatmar-Bereg 4400
    Hungary

    Site Not Available

  • CRU Hungary Kft

    Borsod, 3860
    Hungary

    Site Not Available

  • Semmelweis Egyetem Kardiológiai Rehabilitacio

    Budapest, H-1085
    Hungary

    Site Not Available

  • Észak-Pesti Centrumkórház - Honvédkórház; II. Belgyógyászati Osztály

    Budapest, H-1062
    Hungary

    Site Not Available

  • Belinus BT

    Debrecen, 4025
    Hungary

    Site Not Available

  • Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet

    Debrecen, 4032
    Hungary

    Site Not Available

  • IPR Hungary Kft.

    Miskolc, H-3530
    Hungary

    Site Not Available

  • Borbanya Praxis Eü KFT

    Nyíregyháza, 4405
    Hungary

    Site Not Available

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Szekesfehervar, 8000
    Hungary

    Site Not Available

  • DRC Gyogyszervizsgalo Kozpont Kft

    Veszprém, 8230
    Hungary

    Site Not Available

  • SOROKA Medical Center

    Be'er Sheva, 8410101
    Israel

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 3339416
    Israel

    Site Not Available

  • Lady Davis Carmel Medical Center

    Haifa, 3436212
    Israel

    Site Not Available

  • Hadassah Hebrew University Ein Kerm MC

    Jerusalem, 91120
    Israel

    Site Not Available

  • Shaare Zedek Medical Center

    Jerusalem, 9103102
    Israel

    Site Not Available

  • Rabin Medical Center

    Petach Tikva, 4941492
    Israel

    Site Not Available

  • Kaplan Medical Center

    Reẖovot, 7661041
    Israel

    Site Not Available

  • Sourasky Medical Center

    Tel Aviv, 6423909
    Israel

    Site Not Available

  • Sheba Medical Center

    Tel HaShomer, 5265601
    Israel

    Site Not Available

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di SantOrsola

    Bologna, 40138
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, 20162
    Italy

    Site Not Available

  • Ospdale E. Bassini

    Milano, 20092
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II

    Napoli, 80131
    Italy

    Site Not Available

  • A.O. Policlinico Universitario P. Giaccone

    Palermo, 90127
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, 00168
    Italy

    Site Not Available

  • Policlinico Umberto

    Roma, 00161
    Italy

    Site Not Available

  • Academic Medical Center - Department of Vascular Medicine

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Rijnstate Arnhem

    Arnhem, 6815 AD
    Netherlands

    Site Not Available

  • Albert Schweitzer ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Site Not Available

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP
    Netherlands

    Site Not Available

  • Radboud UMC

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Auckland City Hospital

    Grafton, Auckland 1010
    New Zealand

    Site Not Available

  • New Zealand Clinical Research

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Wellington Regional Hospital

    Newtown, 6021
    New Zealand

    Site Not Available

  • Lipid Clinic

    Oslo, 0586
    Norway

    Site Not Available

  • Salvia

    Katowice, 40-772
    Poland

    Site Not Available

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan, 61-655
    Poland

    Site Not Available

  • ClinMedica Research Sp.z o.o.

    Skierniewice, 96-100
    Poland

    Site Not Available

  • Osrodek Badan Klinicznych Metabolica

    Tarnów, 33-100
    Poland

    Site Not Available

  • Futuremeds sp. z o.o

    Wroclaw, 50-088
    Poland

    Site Not Available

  • Instytut Centrum Zdrowia Matki Polki Klinika

    Łódz, 93-338
    Poland

    Site Not Available

  • Centro Hospitalar do Baixo Vouga Hospital Infante D. Pedro

    Aveiro, 3814-501
    Portugal

    Site Not Available

  • Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3004-561
    Portugal

    Site Not Available

  • Hospital Egas Moniz - Centro Hospitalar de Lisboa Ocidental

    Lisbon, 1349-019
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário de São João Consultas Externas de Endocrinologia K13

    Porto, 4200-319
    Portugal

    Site Not Available

  • Centro Hospitalar

    Vila Nova De Gaia, 4434-502
    Portugal

    Site Not Available

  • Medispektrum s.r.o., diabetologicka a metabolicka ambulancia

    Bratislava, 851 01
    Slovakia

    Site Not Available

  • Nemocnica s poliklinikou Brezno

    Brezno, 97701
    Slovakia

    Site Not Available

  • Vychodoslovensky Ustav srdcovych a cievnych chorob a.s.

    Kosice, 040 11
    Slovakia

    Site Not Available

  • Cardio D&R

    Košice, 040 22
    Slovakia

    Site Not Available

  • Human-Care s.r.o.

    Košice, 040 01
    Slovakia

    Site Not Available

  • Nemocnica arm. generala L. Svobodu Svidnik,

    Svidnik, 089 01
    Slovakia

    Site Not Available

  • Iatros International

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Unitas Hospital

    Centurion, Gauteng 157
    South Africa

    Site Not Available

  • Dr Jan Engelbrecht and Ass. Inc

    Cape Town, Western Cape 7130
    South Africa

    Site Not Available

  • TREAD Research - Department of Cardiology

    Parow, Western Cape 7500
    South Africa

    Site Not Available

  • University of Cape town - Lipid Factory

    Cape Town, 7925
    South Africa

    Site Not Available

  • Chatsmed Garden Hospital

    Chatsworth, 4092
    South Africa

    Site Not Available

  • Hospital Abente y Lago

    A Coruña, 15001
    Spain

    Site Not Available

  • Hospital Clinic Barcelona

    Barcelona, 8063
    Spain

    Site Not Available

  • Hospital Universitari de Bellvitge

    Barcelona, 8907
    Spain

    Site Not Available

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08041
    Spain

    Site Not Available

  • Institut d'Investigació i Innovació Parc Taulí (I3PT) Departament Medicina Universitat

    Barcelona, 8208
    Spain

    Site Not Available

  • Hospital Universitario Reina Sofia

    Córdoba, 14004
    Spain

    Site Not Available

  • Clinica Universidad de Navarra

    Madrid, 28027
    Spain

    Site Not Available

  • Hospital Universitario

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Virgen del Rocio Edificio Centro de Diagnostico y Tratamiento (CDT)

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitari Sant Joan de Reus.

    Tarragona, 43204
    Spain

    Site Not Available

  • Sahlgrenska, University Hospital

    Goteborg, Västra Götalands Län 413 45
    Sweden

    Site Not Available

  • Karolinska University Hospital Huddinge

    Stockholm, 14186
    Sweden

    Site Not Available

  • Hacettepe University Medical Faculty

    Ankara, 06230
    Turkey

    Site Not Available

  • Kocaeli University Faculty of Medicine

    Kocaeli, 41380
    Turkey

    Site Not Available

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42280
    Turkey

    Site Not Available

  • Ege University School of Medicine, Department of Cardiology

    İzmir, 35100
    Turkey

    Site Not Available

  • Oak Tree Surgery and Pensilva Health Centre

    Liskeard, Cornwall PL14 3XA
    United Kingdom

    Site Not Available

  • Newquay Health Centre

    Newquay, Cornwall TR7 1RU
    United Kingdom

    Site Not Available

  • Upton Surgery

    Poole, Dorset BH16 5PW
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Rochdale, England OL11 4AU
    United Kingdom

    Site Not Available

  • Panthera Biopartners

    Sheffield, England S2 5FX
    United Kingdom

    Site Not Available

  • Huddersfield Royal Infirmary

    Lindley, Huddersfield HD3 3EA
    United Kingdom

    Site Not Available

  • Lakeside Healthcare at Corby

    Corby, Northamptonshire NN172UR
    United Kingdom

    Site Not Available

  • Sandwell General Hospital

    Lyne, West Bromwich B71 4HJ
    United Kingdom

    Site Not Available

  • Waterloo Medical Centre

    Blackpool, FY4 3AD
    United Kingdom

    Site Not Available

  • Mounts Bay Medical Hub

    Cornwell, TR27 5DT
    United Kingdom

    Site Not Available

  • Panthera

    Glasgow, G51 4TY
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull, HU3 2JZ
    United Kingdom

    Site Not Available

  • Panthera

    London, EN3 4GS
    United Kingdom

    Site Not Available

  • Manchester University NHS Foundation Trust (MFT)

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Panthera

    Preston, PR2 9QB
    United Kingdom

    Site Not Available

  • Primary Care Sheffield

    Sheffield, S94EU
    United Kingdom

    Site Not Available

  • Accel Research Sites Network

    Birmingham, Alabama 35216
    United States

    Site Not Available

  • Mayo Clinic

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Velocity Clinical Research

    Chula Vista, California 91911
    United States

    Site Not Available

  • Diabetes/Lipid Management & Research Center

    Huntington Beach, California 92648
    United States

    Site Not Available

  • University of California, San Diego (UCSD)

    La Jolla, California 92037
    United States

    Site Not Available

  • LA Universal Research Center, Inc.

    Los Angeles, California 90057
    United States

    Site Not Available

  • America Clinical Trials

    Tarzana, California 91356
    United States

    Site Not Available

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida 33434
    United States

    Site Not Available

  • Southeast Clinical Research LLC

    Chiefland, Florida 32626
    United States

    Site Not Available

  • Westside Center for Clinical Research

    Jacksonville, Florida 32205
    United States

    Site Not Available

  • Finlay Medical Research

    Miami, Florida 33126
    United States

    Site Not Available

  • Innovia Research Center, INC

    Miramar, Florida 33027
    United States

    Site Not Available

  • Ocala Cardiovascular Research

    Ocala, Florida 34471
    United States

    Site Not Available

  • IMA Clinical Research

    Saint Petersburg, Florida 33709
    United States

    Site Not Available

  • VICIS Clinical Research

    Tampa, Florida 33614
    United States

    Site Not Available

  • Bayside Clinical Research

    Trinity, Florida 34655
    United States

    Site Not Available

  • IACT Health

    Columbus, Georgia 31904
    United States

    Site Not Available

  • IMA Clinical Research Chicago

    Chicago, Illinois 60602
    United States

    Site Not Available

  • Affinity Health

    Oak Brook, Illinois 60523
    United States

    Site Not Available

  • West Broadway Clinic

    Council Bluffs, Iowa 51501
    United States

    Site Not Available

  • Kansas University Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Continental Clinical Solutions

    Towson, Maryland 21204
    United States

    Site Not Available

  • University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Aa Mrc, Llc

    Flint, Michigan 48504
    United States

    Site Not Available

  • IMA Clinical Research

    Saint Louis, Missouri 63117
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Bryan Medical Center Clinical Research

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Palm Research Center, INC.

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Hudson County Clinical Trials Research Center

    Union City, New Jersey 07087
    United States

    Site Not Available

  • Modern Medicine

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Northwell Health

    Great Neck, New York 11021
    United States

    Site Not Available

  • Circuit Clinical (Crystal Run Healthcare)

    Middletown, New York 10941
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • NYU Langone

    New York, New York 10016
    United States

    Site Not Available

  • Circuit Clinical

    Niagara Falls, New York 14304
    United States

    Site Not Available

  • Modern Medical

    Syosset, New York 11791
    United States

    Site Not Available

  • Novant Health Cancer Institute Elizabeth Investigational Drug Services

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Cone Medical Center

    Greensboro, North Carolina 27401
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Mount Airy, North Carolina 27030
    United States

    Site Not Available

  • Wake Forest University Health Sciences

    Salem, North Carolina 27157
    United States

    Site Not Available

  • Aventiv Research

    Columbus, Ohio 43213
    United States

    Site Not Available

  • Summit Research Group, LLC

    Munroe Falls, Ohio 44262
    United States

    Site Not Available

  • Hightower Clinical Trial Services

    Oklahoma City, Oklahoma 73102
    United States

    Site Not Available

  • Velocity Clinical Research

    Medford, Oregon 97504
    United States

    Site Not Available

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • Health Concepts

    Rapid City, South Dakota 57702
    United States

    Site Not Available

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee 37404
    United States

    Site Not Available

  • Velocity Clinical Research

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Medicus Alliance Clinical Research

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Velocity Clinical

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Manassas Clinical Research Center

    Manassas, Virginia 20110
    United States

    Site Not Available

  • York Clinical Research LLC

    Norfolk, Virginia 23510
    United States

    Site Not Available

  • West Virginia University Heart and Vascular Institute

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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