A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

January 26, 2024 updated by: Ionis Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study in up to approximately 540 participants. Participants will be randomized to receive olezarsen or placebo in a 53-week treatment period. The length of participation in the study will be approximately 78 weeks, which includes an up to 12-week screening period, a 53-week treatment period, and a 13-week post-treatment evaluation period or transition to open-label extension (OLE) study with up to 1-year treatment.

The Screening Period was extended with no impact to overall study timelines. Endpoints added to provide assessment on the pancreatitis rate after olezarsen reaches steady state levels.

Study Type

Interventional

Enrollment (Estimated)

540

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Recruiting
        • Royal Prince Alfred Hospital
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shoe Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Dr. Heart Pty Ltd at Cholesterol Care Australia
    • Victoria
      • Clayton S., Victoria, Australia, 3168
        • Recruiting
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • Recruiting
        • MHAT Blagoevgrad AD
      • Burgas, Bulgaria, 8008
        • Recruiting
        • Medical Center Doctor Staykov EOOD
      • Dimitrovgrad, Bulgaria, 6400
        • Recruiting
        • Medical Center Diamedical 2013 OOD
      • Gabrovo, Bulgaria, 5300
        • Recruiting
        • MHAT "Dr. Tota Venkova" AD
      • Montana, Bulgaria, 3400
        • Recruiting
        • Medical Center "Hera" EOOD
      • Plovdiv, Bulgaria, 4000
        • Recruiting
        • SHAT "Special Medic" Ltd
      • Ruse, Bulgaria, 7000
        • Recruiting
        • Medical Center Rusemed EOOD
      • Sliven, Bulgaria, 8800
        • Recruiting
        • DCC 1 Sliven
      • Sliven, Bulgaria, 8800
        • Recruiting
        • Gabriela Zhelyazkova
      • Smolyan, Bulgaria, 4700
        • Recruiting
        • Medical Center Smolyan Clinical Research OOD
      • Sofia, Bulgaria, 1606
        • Recruiting
        • Medical Center Endomedical EOOD
      • Sofia, Bulgaria, 1700
        • Recruiting
        • MC Doctor Kalchev OOD
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Medical Centar "KALIMAT"
      • Sofia, Bulgaria, 1797
        • Recruiting
        • UMHAT Sofiamed OOD
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • UMHAT Prof. Dr. Stoyan Kirkovich AD, Clinic of Cardiology
      • Stara Zagora, Bulgaria, 6000
        • Recruiting
        • New Rehabilitation Center
      • Veliko Tarnovo, Bulgaria, 5006
        • Recruiting
        • Medical Centre Nevromedics EOOD
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Recruiting
        • Arc Biosystems
    • Ontario
      • Toronto, Ontario, Canada, M3J 0K2
        • Recruiting
        • Canadian Phase Onward Inc
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Recruiting
        • Ecogene-21
      • Montréal, Quebec, Canada, H2W 1R7
        • Recruiting
        • Institut de recherches cliniques de Montréal (IRCM)
      • Québec, Quebec, Canada, G1V 4W2
        • Recruiting
        • Clinique des Maladies Lipidiques de Quebec Inc.
  • Czechia
      • Brandýs Nad Labem, Czechia, 250 01
        • Recruiting
        • MEDICUS SERVICES s.r.o.
      • Hradec Králové, Czechia, 500-05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove
      • Hradec Králové, Czechia, 500 02
        • Recruiting
        • EDUMED s.r.o.
      • Náchod, Czechia, 547 01
        • Recruiting
        • EDUMED s.r.o.
      • Ostrava, Czechia, 70852
        • Recruiting
        • Fakultni Nemocnice Ostrava
      • Prague, Czechia, 128 08
        • Recruiting
        • Vseobecna Fakultni Nemocnice
      • Prague, Czechia, 15800
        • Recruiting
        • Lekarna Poliklinika Hurka
      • Uherské Hradiště, Czechia, 686 01
        • Recruiting
        • Interni ambulance
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Recruiting
        • Aarhus University Hospital
      • Esbjerg, Denmark, 6700
        • Recruiting
        • Esbjerg Hospital
      • Frederiksberg, Denmark, 2000
        • Recruiting
        • Bispebjerg Hospital
      • Herlev, Denmark, 2730
        • Recruiting
        • Herlev Hospital
      • Herning, Denmark, 7400
        • Recruiting
        • Godstrup Regional Hospital
      • Viborg, Denmark, 8800
        • Recruiting
        • Regionshospitalet Viborg
  • Finland
      • Turku, Finland, 20520
        • Recruiting
        • Turku University Hospital
      • Ylitornio, Finland, 95600
        • Recruiting
        • Ylitornio Health Care Center
  • France
      • Bron, France, 69677
        • Recruiting
        • Hopital Louis Pradel
      • Dijon, France, 21079
        • Recruiting
        • Chu Dijon Bourgogne
      • Marseille, France, 13005
        • Recruiting
        • Hôpital de la Conception
      • Montpellier, France, 34295
        • Recruiting
        • CHU Montpellier - Hôpital Lapeyronie
      • Paris, France, 75013
        • Recruiting
        • Hopital Pitie Salpetriere APHP
      • Saint-Herblain, France, 44093
        • Recruiting
        • CHU Nantes - Hopital Nord Laënnec
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • Stoffwechselcentrum Charite Campus Virchow
      • Dresden, Germany, 1307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
      • Hamburg, Germany, 20253
        • Recruiting
        • Klinische Forschung Hamburg GmbH
      • Hannover, Germany, 30159
        • Recruiting
        • Klinische Forschung Hannover-Mitte GmbH
      • Heidelberg, Germany, 69115
        • Recruiting
        • St. Josefskrankenhaus,
      • Köln, Germany, 50937
        • Recruiting
        • Uniklinik Koln
      • Markkleeberg, Germany, 04416
        • Recruiting
        • Praxis Dr. med. Taggeselle
      • Papenburg, Germany, 26871
        • Recruiting
        • Kardiologische Praxis in Papenburg
      • Witten, Germany, 58455
        • Recruiting
        • Evangelisches Krankenhaus Witten
  • Hungary
      • Borsod, Hungary, 3860
        • Recruiting
        • CRU Hungary Kft
      • Budapest, Hungary, H-1085
        • Recruiting
        • Semmelweis Egyetem Kardiológiai Rehabilitacio
      • Budapest, Hungary, H-1062
        • Recruiting
        • Észak-Pesti Centrumkórház - Honvédkórház; II. Belgyógyászati Osztály
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet
      • Debrecen, Hungary, 4025
        • Recruiting
        • Belinus Bt
      • Miskolc, Hungary, H-3530
        • Recruiting
        • IPR Hungary Kft.
      • Nyíregyháza, Hungary, 4405
        • Recruiting
        • Borbanya Praxis Eü KFT
      • Szekesfehervar, Hungary, 8000
        • Recruiting
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
      • Veszprém, Hungary, 8230
        • Recruiting
        • DRC Gyogyszervizsgalo Kozpont Kft
    • Heves
      • Hatvan, Heves, Hungary, 3000
        • Recruiting
        • BKS Research Kft
    • Szabolcs-Szatmar-Bereg
      • Nyíregyháza, Szabolcs-Szatmar-Bereg, Hungary, 4400
        • Recruiting
        • Medifarma 98 Kft
  • Israel
      • Be'er Sheva, Israel, 8410101
        • Recruiting
        • Soroka Medical Center
      • Haifa, Israel, 3436212
        • Recruiting
        • Lady Davis Carmel Medical Center
      • Haifa, Israel, 3339416
        • Recruiting
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah Hebrew University Ein Kerm MC
      • Petach Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center
      • Reẖovot, Israel, 7661041
        • Recruiting
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423909
        • Recruiting
        • Sourasky Medical Center
      • Tel HaShomer, Israel, 5265601
        • Recruiting
        • Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di SantOrsola
      • Milano, Italy, 20162
        • Recruiting
        • Asst Grande Ospedale Metropolitano Niguarda
      • Milano, Italy, 20092
        • Recruiting
        • Ospdale E. Bassini
      • Napoli, Italy, 80131
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II
      • Palermo, Italy, 90127
        • Recruiting
        • A.O. Policlinico Universitario P. Giaccone
      • Roma, Italy, 00161
        • Recruiting
        • Policlinico Umberto
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Recruiting
        • Academic Medical Center - Department of Vascular Medicine
      • Arnhem, Netherlands, 6815 AD
        • Recruiting
        • Rijnstate Arnhem
      • Dordrecht, Netherlands, 3318 AT
        • Recruiting
        • Albert Schweitzer Ziekenhuis
      • Ede, Netherlands, 6716 RP
        • Recruiting
        • Ziekenhuis Gelderse Vallei
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • Radboud UMC
      • Rotterdam, Netherlands, 3015 GD
        • Recruiting
        • Erasmus MC
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Recruiting
        • New Zealand Clinical Research
      • Newtown, New Zealand, 6021
        • Recruiting
        • Wellington Regional Hospital
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Recruiting
        • Auckland City Hospital
  • Norway
      • Oslo, Norway, 0586
        • Recruiting
        • Lipid Clinic
  • Poland
      • Katowice, Poland, 40-772
        • Recruiting
        • Salvia
      • Poznan, Poland, 61-655
        • Recruiting
        • Praktyka Lekarska Ewa Krzyzagorska
      • Skierniewice, Poland, 96-100
        • Recruiting
        • ClinMedica Research Sp.z o.o.
      • Tarnów, Poland, 33-100
        • Recruiting
        • Osrodek Badan Klinicznych Metabolica
      • Wroclaw, Poland, 50-088
        • Recruiting
        • FutureMeds Sp. z o.o
      • Łódz, Poland, 93-338
        • Recruiting
        • Instytut Centrum Zdrowia Matki Polki Klinika
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Recruiting
        • Centro Hospitalar do Baixo Vouga Hospital Infante D. Pedro
      • Coimbra, Portugal, 3004-561
        • Recruiting
        • Centro Hospitalar e Universitario de Coimbra, EPE
      • Lisbon, Portugal, 1349-019
        • Recruiting
        • Hospital Egas Moniz - Centro Hospitalar de Lisboa Ocidental
      • Porto, Portugal, 4200-319
        • Recruiting
        • Centro Hospitalar Universitário de São João Consultas Externas de Endocrinologia K13
      • Vila Nova De Gaia, Portugal, 4434-502
        • Recruiting
        • Centro Hospitalar
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Recruiting
        • Medispektrum s.r.o., Diabetologicka a metabolicka ambulancia
      • Brezno, Slovakia, 97701
        • Recruiting
        • Nemocnica s poliklinikou Brezno
      • Kosice, Slovakia, 040 11
        • Recruiting
        • Vychodoslovensky Ustav srdcovych a cievnych chorob a.s.
      • Košice, Slovakia, 040 22
        • Recruiting
        • Cardio D&R
      • Košice, Slovakia, 040 01
        • Recruiting
        • Human-Care s.r.o.
      • Svidnik, Slovakia, 089 01
        • Recruiting
        • Nemocnica arm. generala L. Svobodu Svidnik,
  • South Africa
      • Cape Town, South Africa, 7925
        • Recruiting
        • University of Cape town - Lipid Factory
      • Chatsworth, South Africa, 4092
        • Recruiting
        • Chatsmed Garden Hospital
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Recruiting
        • Iatros International
    • Gauteng
      • Centurion, Gauteng, South Africa, 157
        • Recruiting
        • Unitas Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Recruiting
        • Dr Jan Engelbrecht and Ass. Inc
      • Parow, Western Cape, South Africa, 7500
        • Recruiting
        • TREAD Research - Department of Cardiology
  • Spain
      • A Coruña, Spain, 15001
        • Recruiting
        • Hospital Abente y Lago
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i de Sant Pau
      • Barcelona, Spain, 8063
        • Recruiting
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 8208
        • Recruiting
        • Institut d'Investigació i Innovació Parc Taulí (I3PT) Departament Medicina Universitat
      • Barcelona, Spain, 8907
        • Recruiting
        • Hospital Universitari de Bellvitge
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28027
        • Recruiting
        • Clinica Universidad de Navarra
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Virgen del Rocio Edificio Centro de Diagnostico y Tratamiento (CDT)
      • Tarragona, Spain, 43204
        • Recruiting
        • Hospital Universitari Sant Joan de Reus.
  • Sweden
      • Stockholm, Sweden, 14186
        • Recruiting
        • Karolinska University Hospital Huddinge
    • Västra Götalands Län
      • Goteborg, Västra Götalands Län, Sweden, 413 45
        • Recruiting
        • Sahlgrenska, University Hospital
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe University Medical Faculty
      • Kocaeli, Turkey, 41380
        • Recruiting
        • Kocaeli University Faculty of Medicine
      • Konya, Turkey, 42280
        • Recruiting
        • Necmettin Erbakan University Meram Medical Faculty
      • İzmir, Turkey, 35100
        • Recruiting
        • Ege University School of Medicine, Department of Cardiology
  • United Kingdom
      • Blackpool, United Kingdom, FY4 3AD
        • Recruiting
        • Waterloo Medical Centre
      • Cornwell, United Kingdom, TR27 5DT
        • Recruiting
        • Mounts Bay Medical Hub
      • Glasgow, United Kingdom, G51 4TY
        • Recruiting
        • Panthera
      • Hull, United Kingdom, HU3 2JZ
        • Recruiting
        • Hull Royal Infirmary
      • London, United Kingdom, EN3 4GS
        • Recruiting
        • Panthera
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester University NHS Foundation Trust (MFT)
      • Preston, United Kingdom, PR2 9QB
        • Recruiting
        • Panthera
      • Sheffield, United Kingdom, S94EU
        • Recruiting
        • Primary Care Sheffield
    • Cornwall
      • Liskeard, Cornwall, United Kingdom, PL14 3XA
        • Recruiting
        • Oak Tree Surgery and Pensilva Health Centre
      • Newquay, Cornwall, United Kingdom, TR7 1RU
        • Recruiting
        • Newquay Health Centre
    • Dorset
      • Poole, Dorset, United Kingdom, BH16 5PW
        • Recruiting
        • Upton Surgery
    • England
      • Rochdale, England, United Kingdom, OL11 4AU
        • Recruiting
        • Panthera Biopartners
      • Sheffield, England, United Kingdom, S2 5FX
        • Recruiting
        • Panthera Biopartners
    • Huddersfield
      • Lindley, Huddersfield, United Kingdom, HD3 3EA
        • Recruiting
        • Huddersfield Royal Infirmary
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN172UR
        • Recruiting
        • Lakeside Healthcare at Corby
    • West Bromwich
      • Lyne, West Bromwich, United Kingdom, B71 4HJ
        • Recruiting
        • Sandwell General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Recruiting
        • Accel Research Sites Network
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic
    • California
      • Chula Vista, California, United States, 91911
        • Recruiting
        • Velocity Clinical Research
      • Huntington Beach, California, United States, 92648
        • Recruiting
        • Diabetes/Lipid Management & Research Center
      • La Jolla, California, United States, 92037
        • Recruiting
        • University of California, San Diego (UCSD)
      • Los Angeles, California, United States, 90057
        • Recruiting
        • LA Universal Research Center, Inc.
      • Tarzana, California, United States, 91356
        • Recruiting
        • America Clinical Trials
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Recruiting
        • Excel Medical Clinical Trials, LLC
      • Chiefland, Florida, United States, 32626
        • Recruiting
        • Southeast Clinical Research LLC
      • Jacksonville, Florida, United States, 32205
        • Recruiting
        • Westside Center for Clinical Research
      • Miami, Florida, United States, 33126
        • Recruiting
        • Finlay Medical Research
      • Miramar, Florida, United States, 33027
        • Recruiting
        • Innovia Research Center, INC
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Ocala Cardiovascular Research
      • Saint Petersburg, Florida, United States, 33709
        • Recruiting
        • IMA Clinical Research
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Vicis Clinical Research
      • Trinity, Florida, United States, 34655
        • Recruiting
        • Bayside Clinical Research
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • IACT Health
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Recruiting
        • IMA Clinical Research Chicago
      • Oak Brook, Illinois, United States, 60523
        • Recruiting
        • Affinity Health
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • Recruiting
        • West Broadway Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • Kansas University Medical Center
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Recruiting
        • Clinical Trials of America, LLC
    • Maryland
      • Towson, Maryland, United States, 21204
        • Recruiting
        • Continental Clinical Solutions
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy
      • Flint, Michigan, United States, 48504
        • Recruiting
        • Aa Mrc, Llc
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63117
        • Recruiting
        • IMA Clinical Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Bryan Medical Center Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Palm Research Center, Inc.
    • New Jersey
      • Union City, New Jersey, United States, 07087
        • Recruiting
        • Hudson County Clinical Trials Research Center
    • New York
      • Brooklyn, New York, United States, 11235
        • Recruiting
        • Modern Medicine
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Northwell Health
      • Middletown, New York, United States, 10941
        • Recruiting
        • Circuit Clinical (Crystal Run Healthcare)
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone
      • Niagara Falls, New York, United States, 14304
        • Recruiting
        • Circuit Clinical
      • Syosset, New York, United States, 11791
        • Recruiting
        • Modern Medical
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Cancer Institute Elizabeth Investigational Drug Services
      • Greensboro, North Carolina, United States, 27401
        • Recruiting
        • Cone Medical Center
      • Mount Airy, North Carolina, United States, 27030
        • Recruiting
        • Clinical Trials of America, LLC
      • Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Aventiv Research
      • Munroe Falls, Ohio, United States, 44262
        • Recruiting
        • Summit Research Group, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Recruiting
        • Hightower Clinical Trial Services
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Velocity Clinical Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Recruiting
        • The Miriam Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • Health Concepts
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Recruiting
        • Chattanooga Research & Medicine, PLLC
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Recruiting
        • Velocity Clinical Research
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Medicus Alliance Clinical Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Velocity Clinical
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Manassas Clinical Research Center
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • York Clinical Research LLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Heart and Vascular Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
  • Patients 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.

Key Exclusion Criteria:

  • Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
  • Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
  • Total bilirubin > upper limit of normal unless due to Gilbert's syndrome
  • Estimated GFR < 30 mL/min/1.73 m^2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Olezarsen
Olezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Drug: Olezarsen
Olezarsen will be administered by SC injection.
Other Names:
  • ISIS 678354
  • AKCEA-APOCIII-LRx
Placebo Comparator: Placebo
Olezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.
Drug: Placebo
Olezarsen-matching placebo will be administered by SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Fasting TG at 6 Months (Average of Weeks 25 and 27) Compared to Placebo
Time Frame: Baseline and Month 6
Baseline and Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Fasting TG at 12 Months (Average of Weeks 51 and 53) Compared to Placebo
Time Frame: Baseline and Month 12
Baseline and Month 12
Proportion of Participants Who Achieve Fasting TG Less Than (<) 500 milligrams per deciliter (mg/dL) (5.7 millimoles per liter [mmol/L]) at 6 and 12 Months Compared to Placebo
Time Frame: Month 6 and 12
Month 6 and 12
Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) at 6 and 12 Months Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL
Time Frame: Month 6 and 12
Month 6 and 12
Proportion of Participants Who Achieve Fasting TG < 1000 mg/dL (11.29 mmol/L) at 6 and 12 Months Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 1000 mg/dL
Time Frame: Month 6 and Month 12
Month 6 and Month 12
Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Percent Change from Baseline in Fasting Very Low-Density Lipoprotein Cholesterol (VLDL-C) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Percent Change from Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Percent Change from Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at 6 and 12 Months Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo, in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
Time Frame: Week 1 through Week 53
Week 1 through Week 53
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Time Frame: Week 1 through Week 53
Week 1 through Week 53
Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo
Time Frame: Week 13 through Week 53
Week 13 through Week 53
Adjudicated Acute Pancreatitis Event Rate from Week 13 to Week 53 Compared to Placebo in Participants with ≥ 2 Events of Adjudicated Acute Pancreatitis in 5 Years Prior to Enrollment
Time Frame: Week 13 through Week 53
Week 13 through Week 53

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2021

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

October 4, 2021

First Submitted That Met QC Criteria

October 4, 2021

First Posted (Actual)

October 15, 2021

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 678354-CS5
  • 2021-002192-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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