A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
NCT ID: NCT05610280
Last Updated: 2026-02-10
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1478 participants
INTERVENTIONAL
2022-11-21
2025-06-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia
NCT05079919
A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
NCT05355402
A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia
NCT05552326
A Phase II Study To Evaluate the Efficacy And Safety Of HRS-1301 In Participants With Dyslipidemia
NCT07229937
Efficacy Study of Diazoxide Choline to Treat Hypertriglyceridemia
NCT01211847
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Screening Period was extended with no impact to overall study timelines.
A coronary computed tomographic angiography (CTA) sub study will be performed to assess whether triglyceride lowering through inhibition of apoC-III protein synthesis may reduce coronary plaque progression.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Olezarsen
Participants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection up to Week 49.
Olezarsen
Olezarsen will be administered by SC injection.
Placebo
Participants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection up to Week 49.
Placebo
Olezarsen-matching placebo will be administered by SC injection.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olezarsen
Olezarsen will be administered by SC injection.
Placebo
Olezarsen-matching placebo will be administered by SC injection.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
a. Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter \[mmol/L\]) and \<500 mg/dL (5.65 mmol/L) with either
* Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or
* At increased risk for ASCVD
b. Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)
* Participants should be on standard of care (SOC) lipid-lowering medications 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.
Exclusion Criteria
* Alanine aminotransferase or aspartate aminotransferase \> 3.0 × upper limit of normal
* Total bilirubin \> 1.5 upper limit of normal unless due to Gilbert's syndrome
* Estimated GFR \< 30 mL/min/1.73 m\^2
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ionis Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Alabama Clinical Therapeutics, LLC Alabaster
Birmingham, Alabama, United States
Heart Center Research PC
Huntsville, Alabama, United States
Cardiovascular Research Foundation of Southern California
Beverly Hills, California, United States
Westside Medical Associates of Los Angeles
Beverly Hills, California, United States
Diabetes/Lipid Management & Research Center
Huntington Beach, California, United States
University of California, San Diego (UCSD)
La Jolla, California, United States
Clinical Trials Research
Lincoln, California, United States
Amicis Research
Northridge, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Northern California Research
Sacramento, California, United States
Amicis Research Center
Santa Clarita, California, United States
Metabolic Institute of America
Tarzana, California, United States
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States
Amicis Research Center
Valencia, California, United States
Excel Clinical Medical Trials
Boca Raton, Florida, United States
Finlay Medical Research - West Palm
Greenacres City, Florida, United States
Global Research Associates
Homestead, Florida, United States
3Sync Research
Lake Worth, Florida, United States
Finlay Medical Research
Miami, Florida, United States
Advanced Medical Research Institute (AMRI)
Miami, Florida, United States
De La Cruz Research Center, LL
Miami, Florida, United States
Suncoast Clinical Research, Inc. - New Port Richey
New Port Richey, Florida, United States
Suncoast Clinical Research, Inc. - Palm Harbor
New Port Richey, Florida, United States
Proactive Clinical Research
Oakland Park, Florida, United States
Ocala Cardiovascular Research
Ocala, Florida, United States
Comprehensive Medical & Research Center
Plantation, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
St. Johns Center for Clinical Research
Saint Augustine, Florida, United States
JSV Clinical Research Study, Inc
Tampa, Florida, United States
Centricity Research
Columbus, Georgia, United States
Atlanta Heart Specialists
Tucker, Georgia, United States
Evanston Premier Healthcare Research LLC
Evanston, Illinois, United States
Clinical Investigation Specialists, Inc
Gurnee, Illinois, United States
Affinity Health
Park Ridge, Illinois, United States
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, United States
Reid Hospital and Health Care Services
Richmond, Indiana, United States
West Broadway Clinic
Council Bluffs, Iowa, United States
Mercy One Iowa Heart Center
West Des Moines, Iowa, United States
University of Kansas Medical Center (KUMC)
Kansas City, Kansas, United States
Norton Cardiovascular Associates
Louisville, Kentucky, United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States
Maryland Cardiovascular Specialists
Baltimore, Maryland, United States
Aa Mrc, Llc
Flint, Michigan, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Palm Research Center, Inc.
Las Vegas, Nevada, United States
Medical University of South Carolina (MUSC)
Charleston, North Carolina, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Aultman Hospital Cardiology Clinical Trials
Canton, Ohio, United States
McConnell Heart Health Center
Columbus, Ohio, United States
Summit Research Group, LLC
Stow, Ohio, United States
Central Oklahoma Early Detection Center
Edmond, Oklahoma, United States
Green and Seidner Family Practice Associates
Lansdale, Pennsylvania, United States
Main Street Physicians Care Waterway
Little River, South Carolina, United States
OnSite Clinical Solutions, LLC
Rock Hill, South Carolina, United States
Monument Health Clinical Research
Rapid City, South Dakota, United States
Health Concepts
Rapid City, South Dakota, United States
The Jackson Clinic
Jackson, Tennessee, United States
Affinity Health Corp.
Nashville, Tennessee, United States
Tennessee Center for Clinical Trials
Tullahoma, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Juno Research, LLC
Houston, Texas, United States
Texas Institute of Cardiology
McKinney, Texas, United States
Southern Endocrinology Associates
Mesquite, Texas, United States
FMC Science
Round Rock, Texas, United States
Carient Heart & Vascular
Manassas, Virginia, United States
Manassas Clinical Research Center
Manassas, Virginia, United States
Charleston Area Medical Center (CAMC) Clinical Trials Center
Charleston, West Virginia, United States
MHAT Sv. Ivan Rilski - 2003 OOD
Dupnitsa, , Bulgaria
University Multiprofile Hospital for Active Treatment Pulmed OOD
Plovdiv, , Bulgaria
SHATC Medica Cor EAD
Rousse, , Bulgaria
Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD
Sofia, , Bulgaria
MBAL National Cardiology Hospital
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Alexandrovska
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment
Sofia, , Bulgaria
Medico Dental Center ISUL Tsaritsa Yoanna EOOD
Sofia, , Bulgaria
UMHAT Prof. Dr. Stoyan Kirkovich
Stara Zagora, , Bulgaria
Diagnostic Consultative Center Equita (DCC Equita)
Varna, , Bulgaria
Specialized Hospital for Active Treatment of Cardiology
Varna, , Bulgaria
ARC Biosystems
Vancouver, British Columbia, Canada
Centricity Research - Vaughan Endocrinology
Concord, Ontario, Canada
Centricity Research - Etobicoke Endocrinology
Etobicoke, Ontario, Canada
Centricity Research - Oshawa Multispecialty
Oshawa, Ontario, Canada
Bluewater Clinical Research Group Inc
Sarnia, Ontario, Canada
Centricity Research - Toronto LMC Multispecialty
Toronto, Ontario, Canada
Ecogene-21
Chicoutimi, Quebec, Canada
Montreal Heart Institute - Institut de Cardiologie de Montreal
Montreal, Quebec, Canada
Institute de Recherches Cliniques de Montreal
Montreal, Quebec, Canada
Clinique des Maladies Lipidiques de Quebec Inc.
Québec, Quebec, Canada
Centricity Research - Barrie Endocrinology
Barrie, , Canada
Centricity Research - Brampton Endocrinology
Brampton, , Canada
Centre de Recherche Saint-Louis
Québec, , Canada
UNIVMED s.r.o. - Kardiologicka Ambulance
Brno, , Czechia
Cevni ambulance - MATMED s.r.o.
Hodonín, , Czechia
Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod
Jaroměř, , Czechia
Affidea Praha s.r.o.
Prague, , Czechia
Diabetologicka a endokrinologicka ambulance Milan Kvapil s.r.o
Prague, , Czechia
Endokrinologie Cerny Most s.r.o.
Prague, , Czechia
AeskuLab k.s
Teplice, , Czechia
MUDr. Nina Zemkova s.r.o. Interni Ambulance
Uherské Hradiště, , Czechia
Aarhus University Hospital
Aarhus, , Denmark
Sydvestjysk Hospital
Esbjerg, , Denmark
Gentofte Hospital
Hellerup, , Denmark
Godstrup Regional Hospital (Gødstrup)
Herning, , Denmark
OUH Svendborg Hospital
Svendborg, , Denmark
Viborg Regional Hospital
Viborg, , Denmark
HCL Hopital Louis Pradel
Bron, , France
CHU Dijon Bourgogne - Hopital Francois Mitterrand
Dijon, , France
AP-HP Hopital Pitie-Salpetriere
Paris, , France
Groupement de Cooperation Sanitaire (GCS) ELSAN - Polyclinique Vauban
Valenciennes, , France
GHM les Portes du Sud
Vénissieux, , France
Clinexpert Kft.
Budapest, , Hungary
Obudai Egeszsegugyi Centrum
Budapest, , Hungary
CRU Hungary Kft.
Encs, , Hungary
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
Bologna, , Italy
ASST NORD MILANO-Ospedale Edoardo Bassini
Cinisello Balsamo, , Italy
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Cona, , Italy
Centro Cardiologico Monzino
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
Rome, , Italy
Academic Medical Center - Department of Vascular Medicine
Amsterdam, , Netherlands
Ziekenhuis Rijnstate
Arnhem, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Deventer Ziekenhuis
Deventer, , Netherlands
Het Van Weel-Bethesda Ziekenhuis
Dirksland, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Spaarne Gasthuis
Haarlem, , Netherlands
Zuyderland Medisch Centrum
Heerlen, , Netherlands
Bethesda Diabetes Research Center
Hoogeveen, , Netherlands
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, , Netherlands
D&A Research
Sneek, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Albert Schweitzer Ziekenhuis - Location Dordrecht
Zwijndrecht, , Netherlands
Albert Schweitzer Ziekenhuis
Zwijndrecht, , Netherlands
The Lipid Clinic (Oslo University Hospital)
Oslo, , Norway
SALVIA Lekston i Madej s.j.
Katowice, , Poland
Jagiellonskie Centrum Innowacji Sp. z o.o.
Krakow, , Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, , Poland
FutureMeds
Lodz, , Poland
INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych
Lodz, , Poland
Praktyka Lekarska Ewa Krzyzagorska
Poznan, , Poland
FutureMeds Warszawa Centrum
Warsaw, , Poland
Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
Warsaw, , Poland
FutureMeds - Centrum Medyczne AMED Warszawa Targowek
Warsaw, , Poland
Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Klinika Kardiologii i Angiologii Interwencyjnej
Warsaw, , Poland
FutureMeds Sp. z o.o
Wroclaw, , Poland
Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o
Zabrze, , Poland
ETG Zamosc - Pro Life Medica Sp. z o.o
Zamość, , Poland
Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz
Carnaxide, , Portugal
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, , Portugal
Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
Lisbon, , Portugal
Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
Vila Nova de Gaia, , Portugal
Alian, s.r.o., Kardiologicka ambulancia
Bardejov, , Slovakia
Cardio D&R, S.R.O. Kosice
Košice, , Slovakia
Diab sro
Rožňava, , Slovakia
Interna SK, s.r.o., Kardiologicka a interna ambulancia
Svidník, , Slovakia
Hospital Abente y Lago
A Coruña, , Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Calle Villarroel 170
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Kang YM, Weinland J, Murphy SA, Goodrich EL, Zhang S, Li D, Banach M, Stroes E, Lu MT, Tsimikas S, Giugliano RP, Sabatine MS; Essence-TIMI 73b Investigators. Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia. N Engl J Med. 2025 Oct 2;393(13):1279-1291. doi: 10.1056/NEJMoa2507227. Epub 2025 Aug 30.
Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Kang YM, Murphy SA, Zhang S, Lu MT, Karwatowska-Prokopczuk E, Tsimikas S, Giugliano RP, Sabatine MS. Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence-TIMI 73b trial. Am Heart J. 2025 Aug;286:116-124. doi: 10.1016/j.ahj.2025.02.022. Epub 2025 Mar 11.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-501486-53
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ISIS 678354-CS9
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.