A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia
Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis
About this trial
This is an interventional treatment trial for Hypertriglyceridemia focused on measuring ISIS 678354, Olezarsen
Eligibility Criteria
Inclusion Criteria: Participants must fall into 1 of the following groups (a or b): 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: Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening 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 NOTE: Other Inclusion/Exclusion criteria may apply.
Sites / Locations
- Alabama Clinical Therapeutics, LLC AlabasterRecruiting
- Heart Center Research PCRecruiting
- Cardiovascular Research Foundation of Southern CaliforniaRecruiting
- Westside Medical Associates of Los AngelesRecruiting
- Diabetes/Lipid Management & Research CenterRecruiting
- University of California, San Diego (UCSD)Recruiting
- Clinical Trials ResearchRecruiting
- Amicis ResearchRecruiting
- Valley Clinical Trials, Inc.Recruiting
- Northern California ResearchRecruiting
- Amicis Research CenterRecruiting
- Metabolic Institute of AmericaRecruiting
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical CenterRecruiting
- Amicis Research CenterRecruiting
- Excel Clinical Medical TrialsRecruiting
- Finlay Medical Research - West PalmRecruiting
- Global Research AssociatesRecruiting
- 3Sync ResearchRecruiting
- Finlay Medical ResearchRecruiting
- Advanced Medical Research Institute (AMRI)Recruiting
- De La Cruz Research Center, LLRecruiting
- Suncoast Clinical Research, Inc. - New Port RicheyRecruiting
- Suncoast Clinical Research, Inc. - Palm HarborRecruiting
- Proactive Clinical ResearchRecruiting
- Ocala Cardiovascular ResearchRecruiting
- Comprehensive Medical & Research CenterRecruiting
- Progressive Medical ResearchRecruiting
- St. Johns Center for Clinical ResearchRecruiting
- JSV Clinical Research Study, IncRecruiting
- Centricity ResearchRecruiting
- Atlanta Heart SpecialistsRecruiting
- Evanston Premier Healthcare Research LLCRecruiting
- Clinical Investigation Specialists, IncRecruiting
- Affinity HealthRecruiting
- Cardiovascular Research of Northwest Indiana, LLCRecruiting
- Reid Hospital and Health Care ServicesRecruiting
- West Broadway ClinicRecruiting
- Mercy One Iowa Heart CenterRecruiting
- University of Kansas Medical Center (KUMC)Recruiting
- Norton Cardiovascular AssociatesRecruiting
- Louisville Metabolic and Atherosclerosis Research CenterRecruiting
- Maryland Cardiovascular SpecialistsRecruiting
- Aa Mrc, LlcRecruiting
- Palm Research Center, Inc.Recruiting
- Clinical Research of South NevadaRecruiting
- Palm Research Center, Inc.Recruiting
- Medical University of South Carolina (MUSC)Recruiting
- Moses H. Cone Memorial HospitalRecruiting
- Aultman Hospital Cardiology Clinical TrialsRecruiting
- McConnell Heart Health CenterRecruiting
- Summit Research Group, LLCRecruiting
- Central Oklahoma Early Detection CenterRecruiting
- Green and Seidner Family Practice AssociatesRecruiting
- Main Street Physicians Care WaterwayRecruiting
- OnSite Clinical Solutions, LLCRecruiting
- Monument Health Clinical ResearchRecruiting
- Health ConceptsRecruiting
- The Jackson ClinicRecruiting
- Affinity Health Corp.Recruiting
- Tennessee Center for Clinical TrialsRecruiting
- Baylor College of MedicineRecruiting
- Juno Research, LLCRecruiting
- Texas Institute of CardiologyRecruiting
- Southern Endocrinology AssociatesRecruiting
- FMC ScienceRecruiting
- Carient Heart & VascularRecruiting
- Manassas Clinical Research CenterRecruiting
- Charleston Area Medical Center (CAMC) Clinical Trials CenterRecruiting
- University Multiprofile Hospital for Active Treatment Pulmed OODRecruiting
- SHATC Medica Cor EADRecruiting
- Medical Center for Specialized Medical Help in Cardiovascular Diseases OODRecruiting
- MBAL National Cardiology HospitalRecruiting
- University Multiprofile Hospital for Active TreatmentRecruiting
- Medico Dental Center ISUL Tsaritsa Yoanna EOODRecruiting
- UMHAT Prof. Dr. Stoyan KirkovichRecruiting
- Diagnostic Consultative Center Equita (DCC Equita)Recruiting
- Specialized Hospital for Active Treatment of CardiologyRecruiting
- ARC BiosystemsRecruiting
- Centricity Research - Vaughan EndocrinologyRecruiting
- Centricity Research - Etobicoke EndocrinologyRecruiting
- Centricity Research - Oshawa MultispecialtyRecruiting
- Bluewater Clinical Research Group IncRecruiting
- Centricity Research - Toronto LMC MultispecialtyRecruiting
- Ecogene-21Recruiting
- Institute de Recherches Cliniques de MontrealRecruiting
- Clinique des Maladies Lipidiques de Quebec Inc.Recruiting
- Centricity Research - Barrie EndocrinologyRecruiting
- Centricity Research - Brampton EndocrinologyRecruiting
- Centre de Recherche Saint-LouisRecruiting
- UNIVMED s.r.o. - Kardiologicka AmbulanceRecruiting
- Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance NachodRecruiting
- Endokrinologie Cerny Most s.r.o.Recruiting
- Affidea Praha s.r.o.Recruiting
- Diabetologicka a endokrinologicka ambulance Milan Kvapil s.r.oRecruiting
- AeskuLab k.sRecruiting
- MUDr. Nina Zemkova s.r.o. Interni AmbulanceRecruiting
- Aarhus University HospitalRecruiting
- Sydvestjysk HospitalRecruiting
- Gentofte HospitalRecruiting
- Godstrup Regional Hospital (Gødstrup)Recruiting
- OUH Svendborg HospitalRecruiting
- Viborg Regional HospitalRecruiting
- HCL Hopital Louis PradelRecruiting
- CHU Dijon Bourgogne - Hopital Francois MitterrandRecruiting
- AP-HP Hopital Pitie-SalpetriereRecruiting
- Groupement de Cooperation Sanitaire (GCS) ELSAN - Polyclinique VaubanRecruiting
- GHM les Portes du SudRecruiting
- Clinexpert Kft.Recruiting
- Obudai Egeszsegugyi CentrumRecruiting
- CRU Hungary Kft.Recruiting
- ASST NORD MILANO-Ospedale Edoardo BassiniRecruiting
- Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'AnnaRecruiting
- Centro Cardiologico MonzinoRecruiting
- ASST Grande Ospedale Metropolitano NiguardaRecruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconeRecruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro CuoreRecruiting
- Academic Medical Center - Department of Vascular MedicineRecruiting
- Ziekenhuis RijnstateRecruiting
- Reinier de Graaf GasthuisRecruiting
- Deventer ZiekenhuisRecruiting
- Het Van Weel-Bethesda ZiekenhuisRecruiting
- Groene Hart ZiekenhuisRecruiting
- Spaarne GasthuisRecruiting
- Zuyderland Medisch CentrumRecruiting
- Bethesda Diabetes Research CenterRecruiting
- Canisius-Wilhelmina Ziekenhuis (CWZ)Recruiting
- D&A ResearchRecruiting
- Universitair Medisch Centrum UtrechtRecruiting
- Maxima Medisch CentrumRecruiting
- Albert Schweitzer Ziekenhuis - Location DordrechtRecruiting
- The Lipid Clinic (Oslo University Hospital)Recruiting
- SALVIA Lekston i Madej s.j.Recruiting
- Krakowskie Centrum Medyczne Sp. z o.o.Recruiting
- Jagiellonskie Centrum Innowacji Sp. z o.o.Recruiting
- Praktyka Lekarska Ewa KrzyzagorskaRecruiting
- Clinical Best Solutions Sp. z.o.o Spolka KomandytowaRecruiting
- Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Klinika Kardiologii i Angiologii InterwencyjnejRecruiting
- FutureMeds Warszawa CentrumRecruiting
- FutureMeds - Centrum Medyczne AMED Warszawa TargowekRecruiting
- FutureMeds Sp. z o.oRecruiting
- Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. oRecruiting
- FutureMedsRecruiting
- INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych DoroslychRecruiting
- Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa CruzRecruiting
- Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas MonizRecruiting
- Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa MariaRecruiting
- Centro Hospitalar de Vila Nova de Gaia/Espinho EPERecruiting
- Alian, s.r.o., Kardiologicka ambulanciaRecruiting
- Cardio D&R, S.R.O. KosiceRecruiting
- Diab sroRecruiting
- Interna SK, s.r.o., Kardiologicka a interna ambulanciaRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Calle Villarroel 170Recruiting
- Hospital Universitario Reina SofiaRecruiting
- Hospital Clinico Universitario Virgen de la ArrixacaRecruiting
- Hospital Abente y LagoRecruiting
- Hospital Clinico San CarlosRecruiting
- Hospital Universitario Virgen de la VictoriaRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Olezarsen
Placebo
Participants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection for up to Week 49.
Participants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection for up to Week 49.