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

February 5, 2026 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

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multi-center, randomized, double-blind, placebo-controlled study in 617 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.

Study Type

Interventional

Enrollment (Actual)

617

Phase

  • Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

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

Study Locations

  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Saint Leonards, New South Wales, Australia, 2065
        • Royal North Shoe Hospital
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Dr. Heart Pty Ltd at Cholesterol Care Australia
    • Victoria
      • Clayton S., Victoria, Australia, 3168
        • Monash Medical Centre
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • MHAT Blagoevgrad AD
      • Burgas, Bulgaria, 8008
        • Medical Center Doctor Staykov EOOD
      • Dimitrovgrad, Bulgaria, 6400
        • Medical Center Diamedical 2013 OOD
      • Gabrovo, Bulgaria, 5300
        • MHAT "Dr. Tota Venkova" AD
      • Montana, Bulgaria, 3400
        • Medical Center "Hera" EOOD
      • Plovdiv, Bulgaria, 4000
        • SHAT "Special Medic" Ltd
      • Rousse, Bulgaria, 7000
        • Medical Center Rusemed EOOD
      • Sliven, Bulgaria, 8800
        • DCC 1 Sliven
      • Sliven, Bulgaria, 8800
        • Gabriela Zhelyazkova
      • Smolyan, Bulgaria, 4700
        • Medical center Smolyan clinical research OOD
      • Sofia, Bulgaria, 1797
        • UMHAT Sofiamed OOD
      • Sofia, Bulgaria, 1606
        • Medical Center Endomedical EOOD
      • Sofia, Bulgaria, 1680
        • Medical Centar "KALIMAT"
      • Sofia, Bulgaria, 1700
        • MC Doctor Kalchev OOD
      • Stara Zagora, Bulgaria, 6000
        • New Rehabilitation Center
      • Stara Zagora, Bulgaria, 6000
        • UMHAT Prof. Dr. Stoyan Kirkovich AD, Clinic of Cardiology
      • Veliko Tarnovo, Bulgaria, 5006
        • Medical Centre Nevromedics EOOD
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • ARC Biosystems
    • Ontario
      • Toronto, Ontario, Canada, M3J 0K2
        • Canadian Phase Onward Inc
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 7K9
        • Ecogene-21
      • Montreal, Quebec, Canada, H2W 1R7
        • Institut de recherches cliniques de Montréal (IRCM)
      • Québec, Quebec, Canada, G1V 4W2
        • Clinique des Maladies Lipidiques de Quebec Inc.
  • Czechia
      • Brandýs nad Labem, Czechia, 250 01
        • Medicus Services s.r.o.
      • Hradec Králové, Czechia, 500 02
        • EDUMED s.r.o.
      • Hradec Králové, Czechia, 500-05
        • Fakultni nemocnice Hradec Kralove
      • Náchod, Czechia, 547 01
        • EDUMED s.r.o.
      • Ostrava, Czechia, 70852
        • Fakultni Nemocnice Ostrava
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice
      • Prague, Czechia, 15800
        • Lekarna Poliklinika Hurka
      • Uherské Hradiště, Czechia, 686 01
        • Interni ambulance
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital
      • Esbjerg, Denmark, 6700
        • Esbjerg Hospital
      • Frederiksberg, Denmark, 2000
        • Bispebjerg Hospital
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Herning, Denmark, 7400
        • Godstrup Regional Hospital
      • Viborg, Denmark, 8800
        • Regionshospitalet Viborg
  • Finland
      • Turku, Finland, 20520
        • Turku University Hospital
      • Ylitornio, Finland, 95600
        • Ylitornio Health Care Center
  • France
      • Bron, France, 69677
        • Hôpital Louis Pradel
      • Dijon, France, 21079
        • Chu Dijon Bourgogne
      • Marseille, France, 13005
        • Hôpital de la Conception
      • Montpellier, France, 34295
        • CHU Montpellier - Hôpital Lapeyronie
      • Paris, France, 75013
        • Hopital Pitie Salpetriere APHP
      • Saint-Herblain, France, 44093
        • CHU Nantes - Hopital Nord Laënnec
  • Germany
      • Berlin, Germany, 13353
        • Stoffwechselcentrum Charite Campus Virchow
      • Cologne, Germany, 50937
        • Uniklinik Koln
      • Dresden, Germany, 1307
        • Universitaetsklinikum Carl Gustav Carus an der TU Dresden
      • Hamburg, Germany, 20253
        • Klinische Forschung Hamburg GmbH
      • Hanover, Germany, 30159
        • Klinische Forschung Hannover-Mitte GmbH
      • Heidelberg, Germany, 69115
        • St. Josefskrankenhaus,
      • Markkleeberg, Germany, 04416
        • Praxis Dr. med. Taggeselle
      • Papenburg, Germany, 26871
        • Kardiologische Praxis in Papenburg
      • Witten, Germany, 58455
        • Evangelisches Krankenhaus Witten
  • Hungary
      • Borsod, Hungary, 3860
        • CRU Hungary Kft
      • Budapest, Hungary, H-1062
        • Észak-Pesti Centrumkórház - Honvédkórház; II. Belgyógyászati Osztály
      • Budapest, Hungary, H-1085
        • Semmelweis Egyetem Kardiológiai Rehabilitacio
      • Debrecen, Hungary, 4025
        • Belinus Bt
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet
      • Miskolc, Hungary, H-3530
        • IPR Hungary Kft.
      • Nyíregyháza, Hungary, 4405
        • Borbanya Praxis Eü KFT
      • Székesfehérvár, Hungary, 8000
        • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
      • Veszprém, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft
    • Heves County
      • Hatvan, Heves County, Hungary, 3000
        • BKS Research Kft
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
        • Medifarma 98 Kft
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3436212
        • Lady Davis Carmel Medical Center
      • Haifa, Israel, 3339416
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Hebrew University Ein Kerm MC
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Rehovot, Israel, 7661041
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423909
        • Sourasky Medical Center
      • Tel Litwinsky, Israel, 5265601
        • Sheba Medical Center
  • Italy
      • Bologna, Italy, 40138
        • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di SantOrsola
      • Milan, Italy, 20162
        • Asst Grande Ospedale Metropolitano Niguarda
      • Milan, Italy, 20092
        • Ospdale E. Bassini
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
      • Palermo, Italy, 90127
        • A.O. Policlinico Universitario P. Giaccone
      • Roma, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
      • Roma, Italy, 00161
        • Policlinico Umberto
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center - Department of Vascular Medicine
      • Arnhem, Netherlands, 6815 AD
        • Rijnstate Arnhem
      • Dordrecht, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
      • Ede, Netherlands, 6716 RP
        • Ziekenhuis Gelderse Vallei
      • Nijmegen, Netherlands, 6525 GA
        • Radboud UMC
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus MC
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8011
        • New Zealand Clinical Research
      • Newtown, New Zealand, 6021
        • Wellington Regional Hospital
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Auckland City Hospital
  • Norway
      • Oslo, Norway, 0586
        • Lipid Clinic
  • Poland
      • Katowice, Poland, 40-772
        • Salvia
      • Poznan, Poland, 61-655
        • Praktyka Lekarska Ewa Krzyzagorska
      • Skierniewice, Poland, 96-100
        • ClinMedica Research Sp.z o.o.
      • Tarnów, Poland, 33-100
        • Osrodek Badan Klinicznych Metabolica
      • Wroclaw, Poland, 50-088
        • Futuremeds sp. z o.o
      • Łódz, Poland, 93-338
        • Instytut Centrum Zdrowia Matki Polki Klinika
  • Portugal
      • Aveiro, Portugal, 3814-501
        • Centro Hospitalar do Baixo Vouga Hospital Infante D. Pedro
      • Coimbra, Portugal, 3004-561
        • Centro Hospitalar e Universitário de Coimbra, EPE
      • Lisbon, Portugal, 1349-019
        • Hospital Egas Moniz - Centro Hospitalar de Lisboa Ocidental
      • Porto, Portugal, 4200-319
        • Centro Hospitalar Universitário de São João Consultas Externas de Endocrinologia K13
      • Vila Nova de Gaia, Portugal, 4434-502
        • Centro Hospitalar
  • Slovakia
      • Bratislava, Slovakia, 851 01
        • Medispektrum s.r.o., diabetologicka a metabolicka ambulancia
      • Brezno, Slovakia, 97701
        • Nemocnica s poliklinikou Brezno
      • Košice, Slovakia, 040 01
        • Human-Care s.r.o.
      • Košice, Slovakia, 040 22
        • Cardio D&R
      • Košice, Slovakia, 040 11
        • Vychodoslovensky Ustav srdcovych a cievnych chorob a.s.
      • Svidník, Slovakia, 089 01
        • Nemocnica arm. generala L. Svobodu Svidnik,
  • South Africa
      • Cape Town, South Africa, 7925
        • University of Cape town - Lipid Factory
      • Chatsworth, South Africa, 4092
        • Chatsmed Garden Hospital
    • Free State
      • Bloemfontein, Free State, South Africa, 9301
        • Iatros International
    • Gauteng
      • Centurion, Gauteng, South Africa, 157
        • Unitas Hospital
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7130
        • Dr Jan Engelbrecht and Ass. Inc
      • Parow, Western Cape, South Africa, 7500
        • TREAD Research - Department of Cardiology
  • Spain
      • A Coruña, Spain, 15001
        • Hospital Abente y Lago
      • Barcelona, Spain, 8907
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain, 08041
        • Hospital de la Santa Creu i de Sant Pau
      • Barcelona, Spain, 8063
        • Hospital Clinic Barcelona
      • Barcelona, Spain, 8208
        • Institut d'Investigació i Innovació Parc Taulí (I3PT) Departament Medicina Universitat
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28027
        • Clinica Universidad de Navarra
      • Madrid, Spain, 28041
        • Hospital Universitario
      • Seville, Spain, 41013
        • Hospital Virgen del Rocio Edificio Centro de Diagnostico y Tratamiento (CDT)
      • Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus.
  • Sweden
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital Huddinge
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska, University Hospital
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe University Medical Faculty
      • Izmir, Turkey (Türkiye), 35100
        • Ege University School of Medicine, Department of Cardiology
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Faculty of Medicine
      • Konya, Turkey (Türkiye), 42280
        • Necmettin Erbakan University Meram Medical Faculty
  • United Kingdom
      • Blackpool, United Kingdom, FY4 3AD
        • Waterloo Medical Centre
      • Cornwell, United Kingdom, TR27 5DT
        • Mounts Bay Medical Hub
      • Glasgow, United Kingdom, G51 4TY
        • Panthera
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • London, United Kingdom, EN3 4GS
        • Panthera
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust (MFT)
      • Preston, United Kingdom, PR2 9QB
        • Panthera
      • Sheffield, United Kingdom, S94EU
        • Primary Care Sheffield
    • Cornwall
      • Liskeard, Cornwall, United Kingdom, PL14 3XA
        • Oak Tree Surgery and Pensilva Health Centre
      • Newquay, Cornwall, United Kingdom, TR7 1RU
        • Newquay Health Centre
    • Dorset
      • Poole, Dorset, United Kingdom, BH16 5PW
        • Upton Surgery
    • England
      • Rochdale, England, United Kingdom, OL11 4AU
        • Panthera Biopartners
      • Sheffield, England, United Kingdom, S2 5FX
        • Panthera Biopartners
    • Huddersfield
      • Lindley, Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
    • Northamptonshire
      • Corby, Northamptonshire, United Kingdom, NN172UR
        • Lakeside Healthcare at Corby
    • West Bromwich
      • Lyne, West Bromwich, United Kingdom, B71 4HJ
        • Sandwell General Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Accel Research Sites Network
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Chula Vista, California, United States, 91911
        • Velocity Clinical Research
      • Huntington Beach, California, United States, 92648
        • Diabetes/Lipid Management & Research Center
      • La Jolla, California, United States, 92037
        • University of California, San Diego (UCSD)
      • Los Angeles, California, United States, 90057
        • LA Universal Research Center, Inc.
      • Tarzana, California, United States, 91356
        • America Clinical Trials
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials, LLC
      • Chiefland, Florida, United States, 32626
        • Southeast Clinical Research LLC
      • Jacksonville, Florida, United States, 32205
        • Westside Center For Clinical Research
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miramar, Florida, United States, 33027
        • Innovia Research Center, INC
      • Ocala, Florida, United States, 34471
        • Ocala Cardiovascular Research
      • St. Petersburg, Florida, United States, 33709
        • IMA Clinical Research
      • Tampa, Florida, United States, 33614
        • VICIS Clinical Research
      • Trinity, Florida, United States, 34655
        • Bayside Clinical Research
    • Georgia
      • Columbus, Georgia, United States, 31904
        • IACT Health
    • Illinois
      • Chicago, Illinois, United States, 60602
        • IMA Clinical Research Chicago
      • Oak Brook, Illinois, United States, 60523
        • Affinity Health
    • Iowa
      • Council Bluffs, Iowa, United States, 51501
        • West Broadway Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Clinical Trials of America, LLC
    • Maryland
      • Towson, Maryland, United States, 21204
        • Continental Clinical Solutions
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy
      • Flint, Michigan, United States, 48504
        • Aa Mrc, Llc
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, United States, 63117
        • IMA Clinical Research
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Bryan Medical Center Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Palm Research Center, Inc.
    • New Jersey
      • Union City, New Jersey, United States, 07087
        • Hudson County Clinical Trials Research Center
    • New York
      • Brooklyn, New York, United States, 11235
        • Modern Medicine
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • Middletown, New York, United States, 10941
        • Circuit Clinical (Crystal Run Healthcare)
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10016
        • NYU Langone
      • Niagara Falls, New York, United States, 14304
        • Circuit Clinical
      • Syosset, New York, United States, 11791
        • Modern Medical
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novant Health Cancer Institute Elizabeth Investigational Drug Services
      • Greensboro, North Carolina, United States, 27401
        • Cone Medical Center
      • Mount Airy, North Carolina, United States, 27030
        • Clinical Trials of America, LLC
      • Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Aventiv Research
      • Munroe Falls, Ohio, United States, 44262
        • Summit Research Group, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Hightower Clinical Trial Services
    • Oregon
      • Medford, Oregon, United States, 97504
        • Velocity Clinical Research
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Health Concepts
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Research & Medicine, PLLC
    • Texas
      • Cedar Park, Texas, United States, 78613
        • Velocity Clinical Research
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Sugar Land, Texas, United States, 77478
        • Medicus Alliance Clinical Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • Velocity Clinical
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Manassas Clinical Research Center
      • Norfolk, Virginia, United States, 23510
        • York Clinical Research LLC
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • 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 Compared to Placebo
Time Frame: Baseline and Month 6
Baseline and Month 6

Secondary Outcome Measures

Outcome Measure
Time Frame
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo
Time Frame: Week 1 through Week 53
Week 1 through Week 53
Percent Change from Baseline in Fasting TG Compared to Placebo
Time Frame: Baseline and Month 12
Baseline and Month 12
Percent Change from Baseline in Fasting Apolipoprotein C-III (ApoC-III), Remnant Cholesterol and Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) Compared to Placebo
Time Frame: Baseline, Month 6 and 12
Baseline, Month 6 and 12
Proportion of Patients Who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo
Time Frame: Month 12
Month 12
Proportion of Participants Who Achieve Fasting TG < 880 mg/dL (10 mmol/L) Compared to Placebo in the Subgroup of Participants with Baseline TG ≥ 880 mg/dL
Time Frame: Month 12
Month 12
Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Pooled Placebo
Time Frame: Baseline through Month 12
Baseline through Month 12

Collaborators and Investigators

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

Sponsor

Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

October 22, 2024

Study Completion (Actual)

July 8, 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 (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 678354-CS5
  • 2021-002192-19 (EudraCT Number)
  • 2024-510696-38-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Ionis may share anonymized individual participant data, aggregated clinical data, and other types of data that support the results in this study. Data requests from qualified researchers will be considered once all three of the following criteria are met: (1) 12 months from marketing approval of the study drug in both the United States and European Union; (2) 18 months from conclusion of the study; and (3) 6 months from publication of study article. Access would be via a secure environment and is contingent upon approval of a research proposal and entry into an appropriate data use agreement. Requests to access data can be submitted via the website https://vivli.org/ourmember/ionis/.

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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