A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

PHASE3CompletedINTERVENTIONAL
Enrollment

446

Participants

Timeline

Start Date

August 31, 2022

Primary Completion Date

December 17, 2024

Study Completion Date

September 12, 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 (205)

1000

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

1070

Hôpital Erasme, Brussels

1407

Acibadem City Clinic Tokuda University Hospital, Sofia

1527

Medico Dental Center ISUL Tsaritsa Yoanna EOOD, Sofia

1784

Medical Centre Synexus Sofia EOOD, Sofia

3000

UZ Leuven, Leuven

3500

Virga Jessa Hospital, Hasselt

4000

UMHAT - Kaspela EOOD, Plovdiv

University Multiprofile Hospital for Active Treatment Pulmed OOD, Plovdiv

4400

MHAT Pazardzhik AD, Pazardzhik

4700

Medical Center Smolyan Clinical Research OOD, Smolyan

5006

"Medical Centre Nevromedics EOOD", Veliko Tarnovo

6000

Medical Center Zara - Med, Stara Zagora

6304

MHAT Haskovo AD, Haskovo

6400

Medical Center Diamedical EOOD, Dimitrovgrad

7002

UMHAT Kanev AD, Rousse

8000

AZ Sint-Jan Brugge, Bruges

8035

Hospital Vall d'Hebron, Barcelona

8800

MHAT Sliven to MMA Sofia, Sliven

8916

Hospital Germans Trias i Pujol, Badalona

9000

DCC Equita, Varna

Specialized Hospital for Active Treatment of Cardiology, Varna

10437

S.C. SAL MED S.R.L., Cardiologie, Piteşti

10450

Pulau Pinang Hospital, George Town

10626

Centrul Medical Medicover Victoria, Bucharest

10676

AHEPA Building of Evaggelismos, Athens

11501

NYU Langone Hospital - Long Island, Mineola

12462

University General Hospital ATTIKON, Athens

14127

Orchard Park Family Practice, Orchard Park

15123

Hygeia Hospital, Athens

15706

Hospital Provincial de Conxo, Santiago de Compostela

19104

University of Pennsylvania, Philadelphia

20230

Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V., Aguascalientes

21007

Hospital Comarcal Infanta Elena, Huelva

21201

University of Maryland School of Medicine, Baltimore

21229

Maryland Cardiovascular Specialists, Baltimore

23007

Hospital Universitario de Jaen, Jaén

24127

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo

27100

"Fondazione I.R.C.C.S. Policlinico San Matteo c/o C.U.R.M.", Pavia

28041

Hospital Universitario 12 de Octubre, Madrid

28144

OnSite Clinical Solutions, LLC, Salisbury

28557

Diabetes and Endocrinology Consultants, P.C., Morehead City

28645

Clinical Trials of America, LLC, Lenoir

29009

Hospital Regional de Malaga, Málaga

29010

Unidad de Ensayos Clinicos, Málaga

29425

Medical University of South Carolina (MUSC), Charleston

29566

Main Street Physicians Care Waterway, Little River

30265

Randomize Now, Newnan

30322

Emory University, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

31024

Accel Clinical Research, Eatonton

32103

Cientia Investigacion Clinica Sc, Chihuahua City

32209

University of Florida Jacksonville, Jacksonville

32720

Accel Research Sites, DeLand

32751

Meridien Research, Maitland

32807

Combined Research Orlando Phase I-IV, Orlando

33125

Columbus Clinical Services, Miami

33162

Harmony Clinical Research, Inc, North Miami Beach

33305

Chang Gung Medical Foundation - Linkou Branch, Taoyuan District

33325

3Sync Research, Sunrise

33401

Metabolic Research Institute, West Palm Beach

33467

Finlay Medical Research, Greenacres City

33614

R & B Medical Center LLC, Tampa

33634

JSV Clinical Research Study, Inc., Tampa

34000

Hospital Taiping, Taiping

35205

Central Research Associates, Inc., Birmingham

35235

Alabama Clinical Therapeutics, LLC Alabaster, Birmingham

38305

The Jackson Clinic, Jackson

38671

Stern Cardiovascular, Southaven

40202

University of Louisville, Louisville

40213

Louisville Metabolic and Atherosclerosis Research Center (L-MARC), Louisville

40503

The Research Group of Lexington, LLC, Lexington

40705

Taichung Veterans General Hospital, Taichung

41009

Hospital Universitario Virgen Macarena, Seville

43203

The Ohio State University (OSU), Columbus

43302

SV Research LLC, Marion

44124

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

46010

Hospital Clinico Universitario de Valencia, Valencia

46290

St. Vincent Medical Group, Carmel

48307

Onyx Clinical Research, Rochester Hills

48532

Onyx Clinical Research, Flint

49449

Saules seimons medicinos centras, Kaunas

50009

Hospital Universitario Miguel Servet, Zaragoza

53144

Clinical Investigation Specialists Inc., Kenosha

54055

Clinical Research Institute S.C., Tlanepantla

54636

AHEPA University General Hospital of Thessaloniki, Thessaloniki

57701

Monument Health Clinical Research, Rapid City

59100

University Malaya Medical Centre (UMMC), Kuala Lumpur

59300

ELSAN - Polyclinique Vauban, Valenciennes

66160

University of Kansas Medical Center (KUMC), Kansas City

67098

Hopital de Hautepierre, Strasbourg

68100

University General Hospital of Alexandroupoli, Alexandroupoli

69200

GHM les Portes du Sud, Vénissieux

71111

Grace Research, LLC, Bossier City

71201

Clinical Trials of America LA, LLC, Monroe

74133

Oklahoma Heart Institute, Tulsa

75071

Texas Institute of Cardiology, McKinney

75149

SMS Clinical Research, LLC, Mesquite

Southern Endocrinology Associates, Mesquite

76107

Texas Health Family Care, Fort Worth

76550

FMC Science, Lampasas

77017

Vilo Research Group, Houston

77040

Juno Research, Houston

77054

Juno Research, Houston

77074

Clinical Trial Network, Houston

77099

Pioneer Research Solutions, Inc, Houston

77598

Tranquil Research, Webster

78028

Sante Clinical Research, LLC, Kerrville

78229

Diabetes & Glandular Disease Clinic, P.A., San Antonio

78503

DCT - McAllen Primary Care, LLC, McAllen

79761

Permian Research Foundation, Odessa

80756

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Kaohsiung City

81100

AORN S. Anna e S. Sebastiano UOC FARMACIA, Caserta

83106

Ambulancia diabetologicka a poruch latkovej premeny a vyzivy, Bratislava

84058

Aspen Clinical Research, Orem

84401

Ogden Clinic Grandview, Roy

85381

Onyx Clinical Research, Peoria

90015

NRC Research Institute, Los Angeles

97070

Medical Care and Research S.A de C.V., Mérida

98401

Interna a diabetologicka ambulancia - IN-DIA s.r.o., Lučenec

110017

Max Super Specialty Hospital, New Delhi

110060

Sir Ganga Ram Hospital, Delhi

111045

Shin Kong Wu Ho-Su Memorial Hospital, Taipei

251404

Mackay Memorial Hospital, New Taipei City

302017

Eternal Hospital, Jaipur

400007

Bhatia Hospital, Mumbai

430123

Cardioplus Center SRL, Baia Mare

500283

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L, Brasov

510053

Cabinet Medical Individual SC DIANA BARBONTA SRL, Alba

540124

Cardio Med SRL, Târgu Mureş

540142

S.C. Mediab Srl, Târgu Mureş

560069

Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bengaluru

570015

Manipal Hospital Mysore, Mysore

575003

Vinaya Hospital and Research Centre (A Unit of Karnataka Institute of Medical Sciences), Mangaluru

700020

IPGMER, Kolkata

700027

B. M. Birla Heart Research Centre A Unit of the Calcutta Medical Research Institute, Kolkata

704017

National Cheng Kung University Hospital, Tainan City

4000012

KEM Hospital, Mumbai

02114

Massachusetts General Hospital, Boston

C1061AAG

CIPREC - Centro de Investigación y Prevención Cardiovascular, Buenos Aires

C1093AAS

Fundacion Favaloro, Buenos Aires

C1425AGC

Centro Médico Dra. Laura Maffei, Buenos Aires

C1430

Glenny Corp SA, Buenos Aires

W3400CDS

Instituto de Cardiología Corrientes, Corrientes

X5003DCE

Instituto Médico DAMIC, Córdoba

D5700

Centro Medico San Luis, San Luis

X5900JKA

Clínica FUSAVIM Privada, Villa María

30220-140

NUPEC - Nucleo de Pesquisa Clinica, Belo Horizonte

80730-150

Núcleo de Pesquisa Clínica, Curitiba

60430-270

Hospital Universitario Walter Cantidio - UFC, Fortaleza

90035-903

Nucleo de Pesquisa em Cirurgia Vascular, Porto Alegre

20241-180

IBPClin Pesquisa Clinica, Rio de Janeiro

01228-000

CPQuali Pesquisa Clinica, São Paulo

05403-000

Instituto do Coração - HCFMUSP, São Paulo

05403-900

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - FMUSP, São Paulo

13092-133

i9 Pesquisas Clínicas/Loema - Instituto de Pesquisas Clínica & Consultores, São Paulo

A1B 3V6

NL Health Services, St. John's

L6T 0G1

Aggarwal and Associates Ltd., Brampton

N3H 4L5

Joanne F. Liutkus Medicine Professional Corporation, Cambridge

N7t 4X3

Bluewater Clinical Research Group, Sarnia

M5G2C4

Toronto General Hospital, Toronto

J7Z 2V4

Unite de Recherche Clinique, Saint-Jérôme

695 01

CTC Hodonin s.r.o., Hodonín

440 01

KardioBusak s.r.o., Louny

150 06

Fakultni nemocnice v Motole, Prague

198 00

Endokrinologie Cerny Most s.r.o., Prague

267 01

Diabetologická a endokrinologická ambulance Milan Kvapil, Příbram

415 01

AeskuLab k.s, Teplice

H-6500

Lausmed Kft., Baja

H-8230

DRC Gyogyszervizsgalo Kozpont Kft, Balatonfüred

H-1036

Obudai Egeszsegugyi Centrum, Budapest

H1033

Clinexpert Kft., Budapest

H-3200

Pharma4 Trial Kft., Gyöngyös

H-7400

Somogy Varmegyei Kaposi Mor Oktato Korhaz Diabetologiai szakrendeles, Kaposvár

LT-49387

Klinikiniai sprendimai, Kaunas

LT-91131

Clinic of Cardiology and Rehabilitation, Klaipėda

LT-35144

Republican Panevezys Hospital, Panevezys

LT-76206

Pirmoji viltis, Šiauliai

05460

Sultanah Bahiyah Hospital, Alor Star

06700

Clinstile, S.A. de C.V., Mexico City

1081BT

Vumc Amsterdam Medical Center, Amsterdam

7334 DZ

Gelre Ziekenhuizen Apeldoorn, Apeldoorn

2625 AD

Reinier de Graaf Ziekenhuis, Delft

3247BW

Het Van Weel Bethesda ziekenhuis, Dirksland

3318 AT

Albert Schweitzer Ziekenhuis, Dordrecht

7909 AA

Bethesda Diabetes Research Center, Hoogeveen

6532 SZ

Canisius-Wilhelmina Ziekenhuis (CWZ), Nijmegen

80-214

UCK, I Klinika Kardiologii, Gdansk

05-410

Biokinetica, Józefów

40-081

Centrum Medyczne Pratia, Katowice

91-053

Centra Medyczne Medyceusz, Lodz

20-078

Clinical Best Solutions, Lublin

20-412

Etg Lublin, Lublin

60-589

Centrum Zdrowia Metabolicznego, Poznan

00-710

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

03-291

Centrum Medycnze AMED, Warsaw

04-628

Narodowy Instytut Kardiologii im. S. Wyszyńskiego - PIB, Warsaw

22-400

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

1350-352

Hospital CUF Tejo, Lisbon

4520-211

Centro Hospitalar de Entre Douro e Vouga, Santa Maria da Feira

08501

Alian s.r.o., Bardejov

04801

Diab sro, Rožňava

08901

Interna SK, s.r.o., Svidník

07501

Areteus s.r.o, Trebišov

SE-171 64

Acardo MedSite, Solna

Sponsors
All Listed Sponsors
lead

Ionis Pharmaceuticals, Inc.

INDUSTRY