A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
NCT ID: NCT05552326
Last Updated: 2025-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
446 participants
INTERVENTIONAL
2022-08-31
2025-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Olezarsen
Olezarsen will be administered by SC injection.
Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Placebo
Olezarsen-matching placebo will be administered by SC injection.
Interventions
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Olezarsen
Olezarsen will be administered by SC injection.
Placebo
Olezarsen-matching placebo will be administered by SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participants must be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to screening to minimize changes in these medications during the study.
3. Participants must be willing to comply with diet and lifestyle recommendations as able.
Exclusion Criteria
2. Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
3. Total bilirubin \> 1.5 ULN unless due to Gilbert's syndrome
4. Estimated GFR \< 30 mL/min/1.73 m\^2
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Central Research Associates, Inc.
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC Alabaster
Birmingham, Alabama, United States
Onyx Clinical Research
Peoria, Arizona, United States
NRC Research Institute
Los Angeles, California, United States
Accel Research Sites
DeLand, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Meridien Research
Maitland, Florida, United States
Columbus Clinical Services
Miami, Florida, United States
Harmony Clinical Research, Inc
North Miami Beach, Florida, United States
Combined Research Orlando Phase I-IV
Orlando, Florida, United States
3Sync Research
Sunrise, Florida, United States
R & B Medical Center LLC
Tampa, Florida, United States
JSV Clinical Research Study, Inc.
Tampa, Florida, United States
Metabolic Research Institute
West Palm Beach, Florida, United States
Emory University
Atlanta, Georgia, United States
Accel Clinical Research
Eatonton, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Randomize Now
Newnan, Georgia, United States
St. Vincent Medical Group
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
University of Louisville
Louisville, Kentucky, United States
Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
Louisville, Kentucky, United States
Grace Research, LLC
Bossier City, Louisiana, United States
Clinical Trials of America LA, LLC
Monroe, Louisiana, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Onyx Clinical Research
Flint, Michigan, United States
Onyx Clinical Research
Rochester Hills, Michigan, United States
Stern Cardiovascular
Southaven, Mississippi, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Orchard Park Family Practice
Orchard Park, New York, United States
Clinical Trials of America, LLC
Lenoir, North Carolina, United States
Diabetes and Endocrinology Consultants, P.C.
Morehead City, North Carolina, United States
OnSite Clinical Solutions, LLC
Salisbury, North Carolina, United States
The Ohio State University (OSU)
Columbus, Ohio, United States
SV Research LLC
Marion, Ohio, United States
Oklahoma Heart Institute
Tulsa, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Main Street Physicians Care Waterway
Little River, South Carolina, United States
Monument Health Clinical Research
Rapid City, South Dakota, United States
The Jackson Clinic
Jackson, Tennessee, United States
Texas Health Family Care
Fort Worth, Texas, United States
Vilo Research Group
Houston, Texas, United States
Juno Research
Houston, Texas, United States
Juno Research
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
Pioneer Research Solutions, Inc
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 Research
Webster, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Ogden Clinic Grandview
Roy, Utah, United States
Clinical Investigation Specialists Inc.
Kenosha, Wisconsin, United States
CIPREC - Centro de Investigación y Prevención Cardiovascular
Buenos Aires, , Argentina
Fundacion Favaloro
Buenos Aires, , Argentina
Centro Médico Dra. Laura Maffei
Buenos Aires, , Argentina
Glenny Corp SA
Buenos Aires, , Argentina
Instituto de Cardiología Corrientes
Corrientes, , Argentina
Instituto Médico DAMIC
Córdoba, , Argentina
Centro Medico San Luis
San Luis, , Argentina
Clínica FUSAVIM Privada
Villa María, , Argentina
AZ Sint-Jan Brugge
Bruges, , Belgium
Hôpital Erasme
Brussels, , Belgium
Virga Jessa Hospital
Hasselt, , Belgium
UZ Leuven
Leuven, , Belgium
NUPEC - Nucleo de Pesquisa Clinica
Belo Horizonte, , Brazil
Núcleo de Pesquisa Clínica
Curitiba, , Brazil
Hospital Universitario Walter Cantidio - UFC
Fortaleza, , Brazil
Nucleo de Pesquisa em Cirurgia Vascular
Porto Alegre, , Brazil
IBPClin Pesquisa Clinica
Rio de Janeiro, , Brazil
CPQuali Pesquisa Clinica
São Paulo, , Brazil
Instituto do Coração - HCFMUSP
São Paulo, , Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - FMUSP
São Paulo, , Brazil
i9 Pesquisas Clínicas/Loema - Instituto de Pesquisas Clínica & Consultores
São Paulo, , Brazil
Medical Center Diamedical EOOD
Dimitrovgrad, , Bulgaria
MHAT Haskovo AD
Haskovo, , Bulgaria
MHAT Pazardzhik AD
Pazardzhik, , Bulgaria
UMHAT - Kaspela EOOD
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed OOD
Plovdiv, , Bulgaria
UMHAT Kanev AD
Rousse, , Bulgaria
MHAT Sliven to MMA Sofia
Sliven, , Bulgaria
Medical Center Smolyan Clinical Research OOD
Smolyan, , Bulgaria
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
Sofia, , Bulgaria
Acibadem City Clinic Tokuda University Hospital
Sofia, , Bulgaria
Medico Dental Center ISUL Tsaritsa Yoanna EOOD
Sofia, , Bulgaria
Medical Centre Synexus Sofia EOOD
Sofia, , Bulgaria
Medical Center Zara - Med
Stara Zagora, , Bulgaria
DCC Equita
Varna, , Bulgaria
Specialized Hospital for Active Treatment of Cardiology
Varna, , Bulgaria
Medical Centre "Nevromedics" EOOD
Veliko Tarnovo, , Bulgaria
NL Health Services
St. John's, Newfoundland and Labrador, Canada
Aggarwal and Associates Ltd.
Brampton, Ontario, Canada
Joanne F. Liutkus Medicine Professional Corporation
Cambridge, Ontario, Canada
Bluewater Clinical Research Group
Sarnia, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Unite de Recherche Clinique
Saint-Jérôme, Quebec, Canada
CTC Hodonin s.r.o.
Hodonín, , Czechia
KardioBusak s.r.o.
Louny, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Endokrinologie Cerny Most s.r.o.
Prague, , Czechia
Diabetologická a endokrinologická ambulance Milan Kvapil
Příbram, , Czechia
AeskuLab k.s
Teplice, , Czechia
Hopital de Hautepierre
Strasbourg, , France
ELSAN - Polyclinique Vauban
Valenciennes, , France
GHM les Portes du Sud
Vénissieux, , France
University General Hospital of Alexandroupoli
Alexandroupoli, , Greece
AHEPA Building of Evaggelismos
Athens, , Greece
University General Hospital ATTIKON
Athens, , Greece
Hygeia Hospital
Athens, , Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, , Greece
Lausmed Kft.
Baja, , Hungary
DRC Gyogyszervizsgalo Kozpont Kft
Balatonfüred, , Hungary
Obudai Egeszsegugyi Centrum
Budapest, , Hungary
Clinexpert Kft.
Budapest, , Hungary
Pharma4 Trial Kft.
Gyöngyös, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz Diabetologiai szakrendeles
Kaposvár, , Hungary
Max Super Specialty Hospital
New Delhi, National Capital Territory of Delhi, India
B. M. Birla Heart Research Centre A Unit of the Calcutta Medical Research Institute
Kolkata, West Bengal, India
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Bengaluru, , India
Sir Ganga Ram Hospital
Delhi, , India
Eternal Hospital
Jaipur, , India
IPGMER
Kolkata, , India
Vinaya Hospital and Research Centre (A Unit of Karnataka Institute of Medical Sciences)
Mangaluru, , India
KEM Hospital
Mumbai, , India
Bhatia Hospital
Mumbai, , India
Manipal Hospital Mysore
Mysore, , India
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, , Italy
AORN S. Anna e S. Sebastiano UOC FARMACIA
Caserta, , Italy
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Cona, , Italy
Fondazione I.R.C.C.S. Policlinico "San Matteo" c/o C.U.R.M.
Pavia, , Italy
Saules seimons medicinos centras
Kaunas, , Lithuania
Klinikiniai sprendimai
Kaunas, , Lithuania
Clinic of Cardiology and Rehabilitation
Klaipėda, , Lithuania
Republican Panevezys Hospital
Panevezys, , Lithuania
Pirmoji viltis
Šiauliai, , Lithuania
Sultanah Bahiyah Hospital
Alor Star, Kedah, Malaysia
Hospital Taiping
Taiping, Perak, Malaysia
Pulau Pinang Hospital
George Town, Pulau Pinang, Malaysia
University Malaya Medical Centre (UMMC)
Kuala Lumpur, , Malaysia
Medical Care and Research S.A de C.V.
Mérida, Yucatán, Mexico
Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.
Aguascalientes, , Mexico
Cientia Investigacion Clinica Sc
Chihuahua City, , Mexico
Clinstile, S.A. de C.V.
Mexico City, , Mexico
Clinical Research Institute S.C.
Tlanepantla, , Mexico
Vumc Amsterdam Medical Center
Amsterdam, , Netherlands
Gelre Ziekenhuizen Apeldoorn
Apeldoorn, , Netherlands
Reinier de Graaf Ziekenhuis
Delft, , Netherlands
Het Van Weel Bethesda ziekenhuis
Dirksland, , Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, , Netherlands
Bethesda Diabetes Research Center
Hoogeveen, , Netherlands
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, , Netherlands
UCK, I Klinika Kardiologii
Gdansk, , Poland
Biokinetica
Józefów, , Poland
Centrum Medyczne Pratia
Katowice, , Poland
Centra Medyczne Medyceusz
Lodz, , Poland
Clinical Best Solutions
Lublin, , Poland
Etg Lublin
Lublin, , Poland
Centrum Zdrowia Metabolicznego
Poznan, , Poland
Clinical Best Solutions Sp. Z.o.o Spolka Komandytowa
Warsaw, , Poland
Centrum Medycnze AMED
Warsaw, , Poland
Narodowy Instytut Kardiologii im. S. Wyszyńskiego - PIB
Warsaw, , Poland
ETG Zamosc / Pro Life Medica Sp. z o.o.
Zamość, , Poland
Hospital CUF Tejo
Lisbon, , Portugal
Centro Hospitalar de Entre Douro e Vouga
Santa Maria da Feira, , Portugal
Cabinet Medical Individual SC DIANA BARBONTA SRL
Alba, , Romania
Cardioplus Center SRL
Baia Mare, , Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
Brasov, , Romania
Centrul Medical Medicover Victoria
Bucharest, , Romania
S.C. SAL MED S.R.L., Cardiologie
Piteşti, , Romania
Cardio Med SRL
Târgu Mureş, , Romania
S.C. Mediab Srl
Târgu Mureş, , Romania
Alian s.r.o.
Bardejov, , Slovakia
Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
Bratislava, , Slovakia
Interna a diabetologicka ambulancia - IN-DIA s.r.o.
Lučenec, , Slovakia
Diab sro
Rožňava, , Slovakia
Interna SK, s.r.o.
Svidník, , Slovakia
Areteus s.r.o
Trebišov, , Slovakia
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Comarcal Infanta Elena
Huelva, , Spain
Hospital Universitario de Jaen
Jaén, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Regional de Malaga
Málaga, , Spain
Unidad de Ensayos Clinicos
Málaga, , Spain
Hospital Provincial de Conxo
Santiago de Compostela, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Acardo MedSite
Solna, , Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City, , Taiwan
Mackay Memorial Hospital
New Taipei City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou Branch
Taoyuan District, , Taiwan
Countries
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References
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Marston NA, Bergmark BA, Alexander VJ, Karwatowska-Prokopczuk E, Kang YM, Moura FA, Prohaska TA, Zimerman A, Zhang S, Murphy SA, Tsimikas S, Giugliano RP, Sabatine MS. Design and rationale of the CORE-TIMI 72a and CORE2-TIMI 72b trials of olezarsen in patients with severe hypertriglyceridemia. Am Heart J. 2025 Aug;286:125-135. doi: 10.1016/j.ahj.2025.03.003. Epub 2025 Mar 9.
Other Identifiers
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2022-501420-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISIS 678354-CS6
Identifier Type: -
Identifier Source: org_study_id
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