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

PHASE3CompletedINTERVENTIONAL
Enrollment

617

Participants

Timeline

Start Date

October 25, 2021

Primary Completion Date

October 22, 2024

Study Completion Date

July 8, 2025

Conditions
Severe Hypertriglyceridemia
Interventions
DRUG

Olezarsen

Olezarsen will be administered by SC injection.

DRUG

Placebo

Olezarsen-matching placebo will be administered by SC injection.

Trial Locations (209)

157

Unitas Hospital, Centurion

1010

Auckland City Hospital, Grafton

1307

Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Dresden

1606

Medical Center Endomedical EOOD, Sofia

1680

"Medical Centar KALIMAT", Sofia

1700

MC Doctor Kalchev OOD, Sofia

1797

UMHAT Sofiamed OOD, Sofia

2000

Bispebjerg Hospital, Frederiksberg

2050

Royal Prince Alfred Hospital, Camperdown

2065

Royal North Shoe Hospital, Saint Leonards

2700

MHAT Blagoevgrad AD, Blagoevgrad

2730

Herlev Hospital, Herlev

3000

BKS Research Kft, Hatvan

3004

The Alfred Hospital, Melbourne

3168

Monash Medical Centre, Clayton S.

3400

"Medical Center Hera EOOD", Montana

3860

CRU Hungary Kft, Borsod

4000

"SHAT Special Medic Ltd", Plovdiv

4025

Belinus BT, Debrecen

4032

Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet, Debrecen

4092

Chatsmed Garden Hospital, Chatsworth

4102

Dr. Heart Pty Ltd at Cholesterol Care Australia, Woolloongabba

4400

Medifarma 98 Kft, Nyíregyháza

4405

Borbanya Praxis Eü KFT, Nyíregyháza

4700

Medical Center Smolyan Clinical Research OOD, Smolyan

5000

Royal Adelaide Hospital, Adelaide

5006

Medical Centre Nevromedics EOOD, Veliko Tarnovo

5300

"MHAT Dr. Tota Venkova AD", Gabrovo

6000

New Rehabilitation Center, Stara Zagora

UMHAT Prof. Dr. Stoyan Kirkovich AD, Clinic of Cardiology, Stara Zagora

6021

Wellington Regional Hospital, Newtown

6400

Medical Center Diamedical 2013 OOD, Dimitrovgrad

6700

Esbjerg Hospital, Esbjerg

7000

Medical Center Rusemed EOOD, Rousse

7130

Dr Jan Engelbrecht and Ass. Inc, Cape Town

7400

Godstrup Regional Hospital, Herning

7500

TREAD Research - Department of Cardiology, Parow

7925

University of Cape town - Lipid Factory, Cape Town

8000

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz, Székesfehérvár

8008

Medical Center Doctor Staykov EOOD, Burgas

8011

New Zealand Clinical Research, Christchurch

8063

Hospital Clinic Barcelona, Barcelona

8200

Aarhus University Hospital, Aarhus

8208

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

8230

DRC Gyogyszervizsgalo Kozpont Kft, Veszprém

8800

DCC 1 Sliven, Sliven

Gabriela Zhelyazkova, Sliven

Regionshospitalet Viborg, Viborg

8907

Hospital Universitari de Bellvitge, Barcelona

9000

Aalborg University Hospital, Aalborg

9301

Iatros International, Bloemfontein

10016

NYU Langone, New York

10032

Columbia University, New York

10941

Circuit Clinical (Crystal Run Healthcare), Middletown

11021

Northwell Health, Great Neck

11235

Modern Medicine, Brooklyn

11791

Modern Medical, Syosset

13005

Hopital de la Conception, Marseille

13353

Stoffwechselcentrum Charite Campus Virchow, Berlin

14004

Hospital Universitario Reina Sofia, Córdoba

14186

Karolinska University Hospital Huddinge, Stockholm

14304

Circuit Clinical, Niagara Falls

15001

Hospital Abente y Lago, A Coruña

15800

Lekarna Poliklinika Hurka, Prague

20092

Ospdale E. Bassini, Milan

20110

Manassas Clinical Research Center, Manassas

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20253

Klinische Forschung Hamburg GmbH, Hamburg

20520

Turku University Hospital, Turku

21079

CHU Dijon Bourgogne, Dijon

21204

Continental Clinical Solutions, Towson

23510

York Clinical Research LLC, Norfolk

26506

West Virginia University Heart and Vascular Institute, Morgantown

26871

Kardiologische Praxis in Papenburg, Papenburg

27030

Clinical Trials of America, LLC, Mount Airy

27157

Wake Forest University Health Sciences, Salem

27401

Cone Medical Center, Greensboro

28027

Clinica Universidad de Navarra, Madrid

28041

Hospital Universitario, Madrid

28204

Novant Health Cancer Institute Elizabeth Investigational Drug Services, Charlotte

30159

Klinische Forschung Hannover-Mitte GmbH, Hanover

31904

IACT Health, Columbus

32205

Westside Center for Clinical Research, Jacksonville

32626

Southeast Clinical Research LLC, Chiefland

33027

Innovia Research Center, INC, Miramar

33126

Finlay Medical Research, Miami

33434

Excel Medical Clinical Trials, LLC, Boca Raton

33614

VICIS Clinical Research, Tampa

33709

IMA Clinical Research, St. Petersburg

34295

CHU Montpellier - Hôpital Lapeyronie, Montpellier

34471

Ocala Cardiovascular Research, Ocala

34655

Bayside Clinical Research, Trinity

35100

Ege University School of Medicine, Department of Cardiology, Izmir

35216

Accel Research Sites Network, Birmingham

37404

Chattanooga Research & Medicine, PLLC, Chattanooga

40138

IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di SantOrsola, Bologna

41013

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

41380

Kocaeli University Faculty of Medicine, Kocaeli

42280

Necmettin Erbakan University Meram Medical Faculty, Konya

43204

Hospital Universitari Sant Joan de Reus., Tarragona

43213

Aventiv Research, Columbus

44093

CHU Nantes - Hopital Nord Laennec, Saint-Herblain

44262

Summit Research Group, LLC, Munroe Falls

48109

University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy, Ann Arbor

48504

Aa Mrc, Llc, Flint

50937

Uniklinik Köln, Cologne

51501

West Broadway Clinic, Council Bluffs

57702

Health Concepts, Rapid City

58455

Evangelisches Krankenhaus Witten, Witten

60523

Affinity Health, Oak Brook

60602

IMA Clinical Research Chicago, Chicago

63110

Washington University School of Medicine, St Louis

63117

IMA Clinical Research, St Louis

66160

Kansas University Medical Center, Kansas City

68506

Bryan Medical Center Clinical Research, Lincoln

69115

St. Josefskrankenhaus,, Heidelberg

69677

Hôpital Louis Pradel, Bron

70852

Fakultni nemocnice Ostrava, Ostrava

71201

Clinical Trials of America, LLC, Monroe

73102

Hightower Clinical Trial Services, Oklahoma City

75013

Hopital Pitie Salpetriere APHP, Paris

75390

University of Texas Southwestern, Dallas

77030

Baylor College of Medicine, Houston

77478

Medicus Alliance Clinical Research, Sugar Land

78613

Velocity Clinical Research, Cedar Park

80131

Azienda Ospedaliera Universitaria Federico II, Napoli

84088

Velocity Clinical, West Jordan

85259

Mayo Clinic, Scottsdale

89148

Palm Research Center, INC., Las Vegas

90057

LA Universal Research Center, Inc., Los Angeles

90127

A.O. Policlinico Universitario P. Giaccone, Palermo

91120

Hadassah Hebrew University Ein Kerm MC, Jerusalem

91356

America Clinical Trials, Tarzana

91911

Velocity Clinical Research, Chula Vista

92037

University of California, San Diego (UCSD), La Jolla

92648

Diabetes/Lipid Management & Research Center, Huntington Beach

95600

Ylitornio Health Care Center, Ylitornio

97504

Velocity Clinical Research, Medford

97701

Nemocnica s poliklinikou Brezno, Brezno

3339416

Bnai Zion Medical Center, Haifa

3436212

Lady Davis Carmel Medical Center, Haifa

4941492

Rabin Medical Center, Petah Tikva

5265601

Sheba Medical Center, Tel Litwinsky

6423909

Sourasky Medical Center, Tel Aviv

7661041

Kaplan Medical Center, Rehovot

8410101

SOROKA Medical Center, Beersheba

9103102

Shaare Zedek Medical Center, Jerusalem

07087

Hudson County Clinical Trials Research Center, Union City

02906

The Miriam Hospital, Providence

V6Z 2C7

Arc Biosystems, Vancouver

M3J 0K2

Canadian Phase Onward Inc, Toronto

G7H 7K9

Ecogene-21, Chicoutimi

H2W 1R7

Institut de recherches cliniques de Montréal (IRCM), Montreal

G1V 4W2

Clinique des Maladies Lipidiques de Quebec Inc., Québec

250 01

MEDICUS SERVICES s.r.o., Brandýs nad Labem

500 02

EDUMED s.r.o., Hradec Králové

500-05

Fakultní nemocnice Hradec Králové, Hradec Králové

547 01

EDUMED s.r.o., Náchod

128 08

Vseobecna fakultni nemocnice, Prague

686 01

Interni Ambulance, Uherské Hradiště

04416

Praxis Dr. med. Taggeselle, Markkleeberg

H-1062

Észak-Pesti Centrumkórház - Honvédkórház; II. Belgyógyászati Osztály, Budapest

H-1085

Semmelweis Egyetem Kardiológiai Rehabilitacio, Budapest

H-3530

IPR Hungary Kft., Miskolc

00161

Policlinico Umberto, Roma

00168

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

1105 AZ

Academic Medical Center - Department of Vascular Medicine, Amsterdam

6815 AD

Rijnstate Arnhem, Arnhem

3318 AT

Albert Schweitzer ziekenhuis, Dordrecht

6716 RP

Ziekenhuis Gelderse Vallei, Ede

6525 GA

Radboud UMC, Nijmegen

3015 GD

Erasmus MC, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

0586

Lipid Clinic, Oslo

40-772

Salvia, Katowice

61-655

Praktyka Lekarska Ewa Krzyzagorska, Poznan

96-100

ClinMedica Research Sp.z o.o., Skierniewice

33-100

Osrodek Badan Klinicznych Metabolica, Tarnów

50-088

Futuremeds sp. z o.o, Wroclaw

93-338

Instytut Centrum Zdrowia Matki Polki Klinika, Łódz

3814-501

Centro Hospitalar do Baixo Vouga Hospital Infante D. Pedro, Aveiro

3004-561

Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra

1349-019

Hospital Egas Moniz - Centro Hospitalar de Lisboa Ocidental, Lisbon

4200-319

Centro Hospitalar Universitário de São João Consultas Externas de Endocrinologia K13, Porto

4434-502

Centro Hospitalar, Vila Nova de Gaia

851 01

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

040 01

Human-Care s.r.o., Košice

040 11

Vychodoslovensky Ustav srdcovych a cievnych chorob a.s., Košice

040 22

Cardio D&R, Košice

089 01

Nemocnica arm. generala L. Svobodu Svidnik,, Svidník

08041

Hospital de la Santa Creu i de Sant Pau, Barcelona

413 45

Sahlgrenska, University Hospital, Gothenburg

06230

Hacettepe University Medical Faculty, Ankara

PL14 3XA

Oak Tree Surgery and Pensilva Health Centre, Liskeard

TR7 1RU

Newquay Health Centre, Newquay

BH16 5PW

Upton Surgery, Poole

OL11 4AU

Panthera Biopartners, Rochdale

S2 5FX

Panthera Biopartners, Sheffield

HD3 3EA

Huddersfield Royal Infirmary, Lindley

NN172UR

Lakeside Healthcare at Corby, Corby

B71 4HJ

Sandwell General Hospital, Lyne

FY4 3AD

Waterloo Medical Centre, Blackpool

TR27 5DT

Mounts Bay Medical Hub, Cornwell

G51 4TY

Panthera, Glasgow

HU3 2JZ

Hull Royal Infirmary, Hull

EN3 4GS

Panthera, London

M13 9WL

Manchester University NHS Foundation Trust (MFT), Manchester

PR2 9QB

Panthera, Preston

S94EU

Primary Care Sheffield, Sheffield

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY