A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

PHASE3CompletedINTERVENTIONAL
Enrollment

1,478

Participants

Timeline

Start Date

November 21, 2022

Primary Completion Date

August 8, 2024

Study Completion Date

June 9, 2025

Conditions
HypertriglyceridemiaCardiovascular DiseasesAtherosclerosis
Interventions
DRUG

Olezarsen

Olezarsen will be administered by SC injection.

DRUG

Placebo

Olezarsen-matching placebo will be administered by SC injection.

Trial Locations (168)

168

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

424

The Lipid Clinic (Oslo University Hospital), Oslo

1000

Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD, Sofia

1033

Clinexpert Kft., Budapest

1309

MBAL National Cardiology Hospital, Sofia

1431

University Multiprofile Hospital for Active Treatment Alexandrovska, Sofia

University Multiprofile Hospital for Active Treatment, Sofia

1527

Medico Dental Center ISUL Tsaritsa Yoanna EOOD, Sofia

2600

MHAT Sv. Ivan Rilski - 2003 OOD, Dupnitsa

2900

Gentofte Hospital, Hellerup

4000

University Multiprofile Hospital for Active Treatment Pulmed OOD, Plovdiv

5700

OUH Svendborg Hospital, Svendborg

6003

UMHAT Prof. Dr. Stoyan Kirkovich, Stara Zagora

6700

Sydvestjysk Hospital, Esbjerg

7013

SHATC Medica Cor EAD, Rousse

7400

Godstrup Regional Hospital (Gødstrup), Herning

8000

Aarhus University Hospital, Aarhus

8025

Hospital de la Santa Creu i Sant Pau, Barcelona

8036

Calle Villarroel 170, Barcelona

8800

Viborg Regional Hospital, Viborg

8901

Interna SK, s.r.o., Kardiologicka a interna ambulancia, Svidník

8916

Hospital Germans Trias i Pujol, Badalona

9000

Diagnostic Consultative Center Equita (DCC Equita), Varna

9020

Specialized Hospital for Active Treatment of Cardiology, Varna

14004

Hospital Universitario Reina Sofia, Córdoba

15001

Hospital Abente y Lago, A Coruña

19446

Green and Seidner Family Practice Associates, Lansdale

19800

Endokrinologie Cerny Most s.r.o., Prague

20092

ASST NORD MILANO-Ospedale Edoardo Bassini, Cinisello Balsamo

20109

Carient Heart & Vascular, Manassas

20110

Manassas Clinical Research Center, Manassas

20138

Centro Cardiologico Monzino, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21000

CHU Dijon Bourgogne - Hopital Francois Mitterrand, Dijon

21229

Maryland Cardiovascular Specialists, Baltimore

25304

Charleston Area Medical Center (CAMC) Clinical Trials Center, Charleston

27401

Moses H. Cone Memorial Hospital, Greensboro

28040

Hospital Clinico San Carlos, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

29425

Medical University of South Carolina (MUSC), Charleston

29566

Main Street Physicians Care Waterway, Little River

29732

OnSite Clinical Solutions, LLC, Rock Hill

30084

Atlanta Heart Specialists, Tucker

30120

Hospital Clinico Universitario Virgen de la Arrixaca, El Palmar

31904

Centricity Research, Columbus

32086

St. Johns Center for Clinical Research, Saint Augustine

32127

Progressive Medical Research, Port Orange

33030

Global Research Associates, Homestead

33126

Finlay Medical Research, Miami

33174

Advanced Medical Research Institute (AMRI), Miami

33184

De La Cruz Research Center, LL, Miami

33309

Proactive Clinical Research, Oakland Park

33317

Comprehensive Medical & Research Center, Plantation

33434

Excel Clinical Medical Trials, Boca Raton

33460

3Sync Research, Lake Worth

33467

Finlay Medical Research - West Palm, Greenacres City

33634

JSV Clinical Research Study, Inc, Tampa

34471

Ocala Cardiovascular Research, Ocala

34652

Suncoast Clinical Research, Inc. - New Port Richey, New Port Richey

Suncoast Clinical Research, Inc. - Palm Harbor, New Port Richey

35235

Alabama Clinical Therapeutics, LLC Alabaster, Birmingham

35801

Heart Center Research PC, Huntsville

37203

Affinity Health Corp., Nashville

37388

Tennessee Center for Clinical Trials, Tullahoma

38301

The Jackson Clinic, Jackson

40138

IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola, Bologna

40205

Norton Cardiovascular Associates, Louisville

40213

Louisville Metabolic and Atherosclerosis Research Center, Louisville

41009

Hospital Universitario Virgen Macarena, Seville

41013

Hospital Universitario Virgen del Rocio, Seville

43214

McConnell Heart Health Center, Columbus

44124

Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna, Cona

44224

Summit Research Group, LLC, Stow

44710

Aultman Hospital Cardiology Clinical Trials, Canton

46321

Cardiovascular Research of Northwest Indiana, LLC, Munster

47374

Reid Hospital and Health Care Services, Richmond

48504

Aa Mrc, Llc, Flint

49148

Palm Research Center, Inc., Las Vegas

50266

Mercy One Iowa Heart Center, West Des Moines

51501

West Broadway Clinic, Council Bluffs

57701

Monument Health Clinical Research, Rapid City

57702

Health Concepts, Rapid City

59300

Groupement de Cooperation Sanitaire (GCS) ELSAN - Polyclinique Vauban, Valenciennes

60031

Clinical Investigation Specialists, Inc, Gurnee

60068

Affinity Health, Park Ridge

60201

Evanston Premier Healthcare Research LLC, Evanston

60300

UNIVMED s.r.o. - Kardiologicka Ambulance, Brno

66160

University of Kansas Medical Center (KUMC), Kansas City

69200

GHM les Portes du Sud, Vénissieux

69677

HCL Hopital Louis Pradel, Bron

73034

Central Oklahoma Early Detection Center, Edmond

75013

AP-HP Hopital Pitie-Salpetriere, Paris

75071

Texas Institute of Cardiology, McKinney

75149

Southern Endocrinology Associates, Mesquite

77030

Baylor College of Medicine, Houston

77040

Juno Research, LLC, Houston

78681

FMC Science, Round Rock

89104

Clinical Research of South Nevada, Las Vegas

89148

Palm Research Center, Inc., Las Vegas

90127

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone, Palermo

90210

Cardiovascular Research Foundation of Southern California, Beverly Hills

90211

Westside Medical Associates of Los Angeles, Beverly Hills

90502

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center, Torrance

91324

Amicis Research, Northridge

91325

Valley Clinical Trials, Inc., Northridge

91344

Amicis Research Center, Santa Clarita

91355

Amicis Research Center, Valencia

91356

Metabolic Institute of America, Tarzana

92037

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

92648

Diabetes/Lipid Management & Research Center, Huntington Beach

95648

Clinical Trials Research, Lincoln

95821

Northern California Research, Sacramento

V6Z 2C7

ARC Biosystems, Vancouver

L4K 4M2

Centricity Research - Vaughan Endocrinology, Concord

M9R 4E1

Centricity Research - Etobicoke Endocrinology, Etobicoke

L1J 2K9

Centricity Research - Oshawa Multispecialty, Oshawa

N7t 4X3

Bluewater Clinical Research Group Inc, Sarnia

M4G 3E8

Centricity Research - Toronto LMC Multispecialty, Toronto

G7H 7K9

Ecogene-21, Chicoutimi

H1T 1C8

Montreal Heart Institute - Institut de Cardiologie de Montreal, Montreal

H2W 1R7

Institute de Recherches Cliniques de Montreal, Montreal

G1V 4W2

Clinique des Maladies Lipidiques de Quebec Inc., Québec

L4N 7L3

Centricity Research - Barrie Endocrinology, Barrie

L6S 6J6

Centricity Research - Brampton Endocrinology, Brampton

G1W 4R4

Centre de Recherche Saint-Louis, Québec

695 01

Cevni ambulance - MATMED s.r.o., Hodonín

551 01

Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod, Jaroměř

148 00

Affidea Praha s.r.o., Prague

149 00

Diabetologicka a endokrinologicka ambulance Milan Kvapil s.r.o, Prague

415 01

AeskuLab k.s, Teplice

686 68

MUDr. Nina Zemkova s.r.o. Interni Ambulance, Uherské Hradiště

H-1036

Obudai Egeszsegugyi Centrum, Budapest

H-3860

CRU Hungary Kft., Encs

1105AZ

Academic Medical Center - Department of Vascular Medicine, Amsterdam

6815 AD

Ziekenhuis Rijnstate, Arnhem

2625 AD

Reinier de Graaf Gasthuis, Delft

7416 SE

Deventer Ziekenhuis, Deventer

3247 BW

Het Van Weel-Bethesda Ziekenhuis, Dirksland

2803 HH

Groene Hart Ziekenhuis, Gouda

2035 RC

Spaarne Gasthuis, Haarlem

6419 PC

Zuyderland Medisch Centrum, Heerlen

7909 AA

Bethesda Diabetes Research Center, Hoogeveen

6532 SZ

Canisius-Wilhelmina Ziekenhuis (CWZ), Nijmegen

8601 ZR

D&A Research, Sneek

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

5504 DB

Maxima Medisch Centrum, Veldhoven

3331 LZ

Albert Schweitzer Ziekenhuis - Location Dordrecht, Zwijndrecht

Albert Schweitzer Ziekenhuis, Zwijndrecht

40-772

SALVIA Lekston i Madej s.j., Katowice

30-348

Jagiellonskie Centrum Innowacji Sp. z o.o., Krakow

31-501

Krakowskie Centrum Medyczne Sp. z o.o., Krakow

91-363

FutureMeds, Lodz

93-338

INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych, Lodz

61-655

Praktyka Lekarska Ewa Krzyzagorska, Poznan

00-215

FutureMeds Warszawa Centrum, Warsaw

00-710

Clinical Best Solutions Sp. z.o.o Spolka Komandytowa, Warsaw

03-291

FutureMeds - Centrum Medyczne AMED Warszawa Targowek, Warsaw

04-628

Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Klinika Kardiologii i Angiologii Interwencyjnej, Warsaw

50-088

FutureMeds Sp. z o.o, Wroclaw

48-100

Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o, Zabrze

22-400

ETG Zamosc - Pro Life Medica Sp. z o.o, Zamość

2790-134

Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz, Carnaxide

1349-019

Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz, Lisbon

1649-036

Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria, Lisbon

4434-502

Centro Hospitalar de Vila Nova de Gaia/Espinho EPE, Vila Nova de Gaia

085 01

Alian, s.r.o., Kardiologicka ambulancia, Bardejov

040 22

Cardio D&R, S.R.O. Kosice, Košice

048 01

Diab sro, Rožňava

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY