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ACTIVE NOT RECRUITING
NCT05681351
PHASE3

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

Sponsor: Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

885

Start Date

2022-12-13

Completion Date

2027-03

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DRUG

Olezarsen

Administered as SC injection.

Locations (262)

LA Universal Research Center, Inc.

Los Angeles, California, United States

University of California, San Diego (UCSD)

San Diego, California, United States

Metabolic Institute of America

Tarzana, California, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Finlay Medical Research

Greenacres City, Florida, United States

Columbus Clinical Services, LLC

Miami, Florida, United States

Finlay Medical Research

Miami, Florida, United States

Innovia Research Center, Inc.

Miramar, Florida, United States

Harmony Clinical Research, Inc.

North Miami Beach, Florida, United States

R & B Medical Center LLC

Tampa, Florida, United States

VICIS Clinical Research

Tampa, Florida, United States

JSV Clinical Research Study, Inc.

Tampa, Florida, United States

Bayside Clinical Research

Trinity, Florida, United States

Centricity Research

Columbus, Georgia, United States

IACT Health

Columbus, Georgia, United States

Affinity Health

Oak Brook, Illinois, United States

St. Vincent Medical Group, Inc.

Carmel, Indiana, United States

University of Kansas Medical Center (KUMC)

Kansas City, Kansas, United States

The Research Group of Lexington, LLC

Lexington, Kentucky, United States

Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

Louisville, Kentucky, United States

Grace Research, LLC

Bossier City, Louisiana, United States

University of Maryland School of Medicine

Baltimore, Maryland, United States

IRC Clinics

Towson, Maryland, United States

Massachusetts General Hospital Heart Center

Boston, Massachusetts, United States

University of Michigan- Endocrinology & Metabolism

Ann Arbor, Michigan, United States

Aa Mrc, Llc

Flint, Michigan, United States

Washington School of Medicine

St Louis, Missouri, United States

Bryan Medical Center

Lincoln, Nebraska, United States

Palm Research Center, Inc.

Las Vegas, Nevada, United States

Hudson County Clinical Trials Research Center

Union City, New Jersey, United States

Modern Medical

Brooklyn, New York, United States

NYU Langone Health

Mineola, New York, United States

Langone Medical Center

New York, New York, United States

Vagelos College of Physicians and Surgeons of Columbia University

New York, New York, United States

Orchard Park Family Practice

Orchard Park, New York, United States

The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Kenneth Hilty

Greensboro, North Carolina, United States

Clinical Trials of America, LLC

Lenoir, North Carolina, United States

Lexington

Winston-Salem, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Central Oklahoma Early Detection Center

Edmond, Oklahoma, United States

Oklahoma Heart Institute

Tulsa, Oklahoma, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Walker Family Care

Little River, South Carolina, United States

Monument Health Clinical Research

Rapid City, South Dakota, United States

Health Concepts

Rapid City, South Dakota, United States

Chattanooga Research & Medicine, PLLC

Chattanooga, Tennessee, United States

The Jackson Clinic

Jackson, Tennessee, United States

University of Texas Southwestern

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Juno Research

Houston, Texas, United States

Pioneer Research Solutions

Houston, Texas, United States

Sante Clinical Research LLC

Kerrville, Texas, United States

FMC Science

Lampasas, Texas, United States

DCT- McAllen Primary Care, LLC

McAllen, Texas, United States

Texas Institute of Cardiology

McKinney, Texas, United States

SMS Clinical Research, LLC

Mesquite, Texas, United States

Southern Endocrinology Associates

Mesquite, Texas, United States

Permian Research Foundation

Odessa, Texas, United States

Diabetes & Glandular Disease Clinic, P.A.

San Antonio, Texas, United States

Tranquil Clinical and Research Consulting Services

Webster, Texas, United States

Manassas Clinical Research

Manassas, Virginia, United States

York Clinical Research

Norfolk, Virginia, United States

WVU Heart and Vascular Institute

Morgantown, West Virginia, United States

CIPREC

Buenos Aires, Argentina

Fundacion Favaloro

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei-Investigacion Clinica Aplicad

Buenos Aires, Argentina

Glenny Corp SA

Buenos Aires, Argentina

Instituto Medico DAMIC

Córdoba, Argentina

Clinica FUSAVIM Privada

Villa María, Argentina

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

Monash Medical Centre

Clayton, Australia

Dr Heart Pty Ltd

Woolloongabba, Australia

Universite Libre de Brussels (ULB)- Hopital Erasme

Brussels, Belgium

Jessa Ziekenhuis

Hasselt, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Centro Especializado em Cardiologia

Campinas, Brazil

Nucleo de Pesquisa Clinica S/S

Curitiba, Brazil

Hospital Universitario Walter Cantidio- UFC

Fortaleza, Brazil

Nucleo de Pasquisa em Cirurgia Vascular

Porto Alegre, Brazil

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

São Paulo, Brazil

Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP

São Paulo, Brazil

CPQuali Pesquisa Clinica Ltda.

São Paulo, Brazil

MHAT- Blagoevgrad AD

Blagoevgrad, Bulgaria

Medical Center Doctor Staykov EOOD

Burgas, Bulgaria

Medical Center Diamedical 2013 OOD

Dimitrovgrad, Bulgaria

MHAT

Gabrovo, Bulgaria

MHAT Haskovo AD

Haskovo, Bulgaria

Multiprofile Hospital for Active Treament Pazardzhik, Cardiology Department

Pazardzhik, Bulgaria

SBAL "Special Medic" Ltd.

Plovdiv, Bulgaria

UHMAT Kaspela Ltd

Plovdiv, Bulgaria

University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology

Plovdiv, Bulgaria

Medical Center Rusemed EOOD

Rousse, Bulgaria

UMHAT Kanev AD

Rousse, Bulgaria

DCC-1 Sliven Ltd.

Sliven, Bulgaria

Medical Center Smolyan Clinical Research OOD

Smolyan, Bulgaria

Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

Sofia, Bulgaria

And 162 more locations on ClinicalTrials.gov