A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or With Severe Hypertriglyceridemia

The purpose of the study is to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Atherosclerosis; Hypertriglyceridemia
• Intervention / Treatment: Drug: Olezarsen; Drug: Placebo

Detailed Description

This is a Phase 3, multi-center, placebo-controlled study in approximately 1475 participants with hypertriglyceridemia and atherosclerotic cardiovascular disease. The study consists of 3 periods: 1) Screening Period: Week -12 to Week -1 (up to 12 weeks); 2) Treatment Period up to Week 53; and 3) Post-Treatment Follow-up Period: Week 54 to Week 66 (13 weeks). Participants enrolled will receive olezarsen or placebo once every 4 weeks during the 53-week Treatment Period.

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.

• Study Type: Interventional
• Enrollment (Actual): 1478
• Phase: Phase 3

Expanded Access

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Contacts and Locations

Study Locations

• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • MHAT Sv. Ivan Rilski - 2003 OOD
  • Plovdiv, Bulgaria, 4000
    • University Multiprofile Hospital for Active Treatment Pulmed OOD
  • Rousse, Bulgaria, 7013
    • SHATC Medica Cor EAD
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment Alexandrovska
  • Sofia, Bulgaria, 1000
    • Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD
  • Sofia, Bulgaria, 1309
    • MBAL National Cardiology Hospital
  • Sofia, Bulgaria, 1431
    • University Multiprofile Hospital for Active Treatment
  • Sofia, Bulgaria, 1527
    • Medico Dental Center ISUL Tsaritsa Yoanna EOOD
  • Stara Zagora, Bulgaria, 6003
    • UMHAT Prof. Dr. Stoyan Kirkovich
  • Varna, Bulgaria, 9000
    • Diagnostic Consultative Center Equita (DCC Equita)
  • Varna, Bulgaria, 9020
    • Specialized Hospital for Active Treatment of Cardiology
• Canada
  • Barrie, Canada, L4N 7L3
    • Centricity Research - Barrie Endocrinology
  • Brampton, Canada, L6S 6J6
    • Centricity Research - Brampton Endocrinology
  • Québec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2C7
      • ARC Biosystems
  • Ontario
    • Concord, Ontario, Canada, L4K 4M2
      • Centricity Research - Vaughan Endocrinology
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Centricity Research - Etobicoke Endocrinology
    • Oshawa, Ontario, Canada, L1J 2K9
      • Centricity Research - Oshawa Multispecialty
    • Sarnia, Ontario, Canada, N7t 4X3
      • Bluewater Clinical Research Group Inc
    • Toronto, Ontario, Canada, M4G 3E8
      • Centricity Research - Toronto LMC Multispecialty
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • Ecogene-21
    • Montreal, Quebec, Canada, H2W 1R7
      • Institute de Recherches Cliniques de Montreal
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute - Institut de Cardiologie de Montreal
    • Québec, Quebec, Canada, G1V 4W2
      • Clinique des Maladies Lipidiques de Quebec Inc.
• Czechia
  • Brno, Czechia, 60300
    • UNIVMED s.r.o. - Kardiologicka Ambulance
  • Hodonín, Czechia, 695 01
    • Cevni ambulance - MATMED s.r.o.
  • Jaroměř, Czechia, 551 01
    • Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod
  • Prague, Czechia, 148 00
    • Affidea Praha s.r.o.
  • Prague, Czechia, 19800
    • Endokrinologie Cerny Most s.r.o.
  • Prague, Czechia, 149 00
    • Diabetologicka a endokrinologicka ambulance Milan Kvapil s.r.o
  • Teplice, Czechia, 415 01
    • AeskuLab k.s
  • Uherské Hradiště, Czechia, 686 68
    • MUDr. Nina Zemkova s.r.o. Interni Ambulance
• Denmark
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Esbjerg, Denmark, 6700
    • Sydvestjysk Hospital
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • Herning, Denmark, 7400
    • Godstrup Regional Hospital (Gødstrup)
  • Svendborg, Denmark, 5700
    • OUH Svendborg Hospital
  • Viborg, Denmark, 8800
    • Viborg Regional Hospital
• France
  • Bron, France, 69677
    • HCL Hôpital Louis Pradel
  • Dijon, France, 21000
    • CHU Dijon Bourgogne - Hopital Francois Mitterrand
  • Paris, France, 75013
    • AP-HP Hopital Pitie-Salpetriere
  • Valenciennes, France, 59300
    • Groupement de Cooperation Sanitaire (GCS) ELSAN - Polyclinique Vauban
  • Vénissieux, France, 69200
    • GHM les Portes du Sud
• Hungary
  • Budapest, Hungary, 1033
    • Clinexpert Kft.
  • Budapest, Hungary, H-1036
    • Óbudai Egészségügyi Centrum
  • Encs, Hungary, H-3860
    • CRU Hungary Kft.
• Italy
  • Bologna, Italy, 40138
    • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola
  • Cinisello Balsamo, Italy, 20092
    • ASST NORD MILANO-Ospedale Edoardo Bassini
  • Cona, Italy, 44124
    • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Palermo, Italy, 90127
    • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  • Rome, Italy, 168
    • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore
• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Academic Medical Center - Department of Vascular Medicine
  • Arnhem, Netherlands, 6815 AD
    • Ziekenhuis Rijnstate
  • Delft, Netherlands, 2625 AD
    • Reinier de Graaf Gasthuis
  • Deventer, Netherlands, 7416 SE
    • Deventer Ziekenhuis
  • Dirksland, Netherlands, 3247 BW
    • Het Van Weel-Bethesda Ziekenhuis
  • Gouda, Netherlands, 2803 HH
    • Groene Hart Ziekenhuis
  • Haarlem, Netherlands, 2035 RC
    • Spaarne Gasthuis
  • Heerlen, Netherlands, 6419 PC
    • Zuyderland Medisch Centrum
  • Hoogeveen, Netherlands, 7909 AA
    • Bethesda Diabetes Research Center
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelmina Ziekenhuis (CWZ)
  • Sneek, Netherlands, 8601 ZR
    • D&A Research
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
  • Veldhoven, Netherlands, 5504 DB
    • Maxima Medisch Centrum
  • Zwijndrecht, Netherlands, 3331 LZ
    • Albert Schweitzer Ziekenhuis
  • Zwijndrecht, Netherlands, 3331 LZ
    • Albert Schweitzer Ziekenhuis - Location Dordrecht
• Norway
  • Oslo, Norway, 424
    • The Lipid Clinic (Oslo University Hospital)
• Poland
  • Katowice, Poland, 40-772
    • SALVIA Lekston i Madej s.j.
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Krakow, Poland, 30-348
    • Jagiellońskie Centrum Innowacji Sp. z o.o.
  • Lodz, Poland, 91-363
    • FutureMeds
  • Lodz, Poland, 93-338
    • INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych
  • Poznan, Poland, 61-655
    • Praktyka Lekarska Ewa Krzyzagorska
  • Warsaw, Poland, 00-710
    • Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
  • Warsaw, Poland, 04-628
    • Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Klinika Kardiologii i Angiologii Interwencyjnej
  • Warsaw, Poland, 00-215
    • FutureMeds Warszawa Centrum
  • Warsaw, Poland, 03-291
    • FutureMeds - Centrum Medyczne AMED Warszawa Targowek
  • Wroclaw, Poland, 50-088
    • Futuremeds sp. z o.o
  • Zabrze, Poland, 48-100
    • Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o
  • Zamość, Poland, 22-400
    • ETG Zamosc - Pro Life Medica Sp. z o.o
• Portugal
  • Carnaxide, Portugal, 2790-134
    • Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz
  • Lisbon, Portugal, 1349-019
    • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz
  • Lisbon, Portugal, 1649-036
    • Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria
  • Vila Nova de Gaia, Portugal, 4434-502
    • Centro Hospitalar de Vila Nova de Gaia/Espinho EPE
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Alian, s.r.o., Kardiologicka ambulancia
  • Košice, Slovakia, 040 22
    • Cardio D&R, S.R.O. Kosice
  • Rožňava, Slovakia, 048 01
    • DIAB sro
  • Svidník, Slovakia, 8901
    • Interna SK, s.r.o., Kardiologicka a interna ambulancia
• Spain
  • A Coruña, Spain, 15001
    • Hospital Abente y Lago
  • Badalona, Spain, 8916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 8025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 8036
    • Calle Villarroel 170
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofia
  • El Palmar, Spain, 30120
    • Hospital Clínico Universitario Virgen de la Arrixaca
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Málaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC Alabaster
    • Huntsville, Alabama, United States, 35801
      • Heart Center Research PC
  • California
    • Beverly Hills, California, United States, 90211
      • Westside Medical Associates of Los Angeles
    • Beverly Hills, California, United States, 90210
      • Cardiovascular Research Foundation of Southern California
    • Huntington Beach, California, United States, 92648
      • Diabetes/Lipid Management & Research Center
    • La Jolla, California, United States, 92037
      • University of California, San Diego (UCSD)
    • Lincoln, California, United States, 95648
      • Clinical Trials Research
    • Northridge, California, United States, 91325
      • Valley Clinical Trials, Inc.
    • Northridge, California, United States, 91324
      • Amicis Research
    • Sacramento, California, United States, 95821
      • Northern California Research
    • Santa Clarita, California, United States, 91344
      • Amicis Research Center
    • Tarzana, California, United States, 91356
      • Metabolic Institute of America
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
    • Valencia, California, United States, 91355
      • Amicis Research Center
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Clinical Medical Trials
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research - West Palm
    • Homestead, Florida, United States, 33030
      • Global Research Associates
    • Lake Worth, Florida, United States, 33460
      • 3Sync Research
    • Miami, Florida, United States, 33174
      • Advanced Medical Research Institute (AMRI)
    • Miami, Florida, United States, 33126
      • Finlay Medical Research
    • Miami, Florida, United States, 33184
      • De La Cruz Research Center, LL
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc. - New Port Richey
    • New Port Richey, Florida, United States, 34652
      • Suncoast Clinical Research, Inc. - Palm Harbor
    • Oakland Park, Florida, United States, 33309
      • Proactive Clinical Research
    • Ocala, Florida, United States, 34471
      • Ocala Cardiovascular Research
    • Plantation, Florida, United States, 33317
      • Comprehensive Medical & Research Center
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Saint Augustine, Florida, United States, 32086
      • St. Johns Center for Clinical Research
    • Tampa, Florida, United States, 33634
      • JSV Clinical Research Study, Inc
  • Georgia
    • Columbus, Georgia, United States, 31904
      • Centricity Research
    • Tucker, Georgia, United States, 30084
      • Atlanta Heart Specialists
  • Illinois
    • Evanston, Illinois, United States, 60201
      • Evanston Premier Healthcare Research LLC
    • Gurnee, Illinois, United States, 60031
      • Clinical Investigation Specialists, Inc
    • Park Ridge, Illinois, United States, 60068
      • Affinity Health
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana, LLC
    • Richmond, Indiana, United States, 47374
      • Reid Hospital and Health Care Services
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • West Broadway Clinic
    • West Des Moines, Iowa, United States, 50266
      • Mercy One Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center (KUMC)
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Louisville Metabolic and Atherosclerosis Research Center
    • Louisville, Kentucky, United States, 40205
      • Norton Cardiovascular Associates
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Maryland Cardiovascular Specialists
  • Michigan
    • Flint, Michigan, United States, 48504
      • Aa Mrc, Llc
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Palm Research Center, Inc.
    • Las Vegas, Nevada, United States, 49148
      • Palm Research Center, Inc.
    • Las Vegas, Nevada, United States, 89104
      • Clinical Research of South Nevada
  • North Carolina
    • Charleston, North Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • Greensboro, North Carolina, United States, 27401
      • Moses H. Cone Memorial Hospital
  • Ohio
    • Canton, Ohio, United States, 44710
      • Aultman Hospital Cardiology Clinical Trials
    • Columbus, Ohio, United States, 43214
      • McConnell Heart Health Center
    • Stow, Ohio, United States, 44224
      • Summit Research Group, LLC
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Central Oklahoma Early Detection Center
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Green and Seidner Family Practice Associates
  • South Carolina
    • Little River, South Carolina, United States, 29566
      • Main Street Physicians Care Waterway
    • Rock Hill, South Carolina, United States, 29732
      • OnSite Clinical Solutions, LLC
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • The Jackson Clinic
    • Nashville, Tennessee, United States, 37203
      • Affinity Health Corp.
    • Tullahoma, Tennessee, United States, 37388
      • Tennessee Center for Clinical Trials
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77040
      • Juno Research, LLC
    • McKinney, Texas, United States, 75071
      • Texas Institute of Cardiology
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • Round Rock, Texas, United States, 78681
      • FMC Science
  • Virginia
    • Manassas, Virginia, United States, 20110
      • Manassas Clinical Research Center
    • Manassas, Virginia, United States, 20109
      • Carient Heart & Vascular
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Charleston Area Medical Center (CAMC) Clinical Trials Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olezarsen; Participants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection up to Week 49.	Drug: Olezarsen; Olezarsen will be administered by SC injection.; Other Names: ISIS 678354; AKCEA-APOCIII-LRx
Placebo Comparator: Placebo; Participants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection up to 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 to Week 25 in Fasting Triglycerides (TG) Compared to Placebo	Baseline to Week 25

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change From Baseline to Week 53 in Fasting TG Compared to Placebo	Baseline to Week 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein C-III (apoC-III) Compared to Placebo	Baseline to Weeks 25 and 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting Very Low-Density Lipoprotein-Cholesterol (VLDL)-C Compared to Placebo	Baseline to Weeks 25 and 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting Remnant Cholesterol Compared to Placebo	Baseline to Weeks 25 and 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting non-High Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo	Baseline to Weeks 25 and 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting High-Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo	Baseline to Weeks 25 and 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein B (apoB) Compared to Placebo	Baseline to Weeks 25 and 53
Percent Change From Baseline to Weeks 25 and 53 in Fasting Low-Density Lipoprotein-Cholesterol (LDL)-C Compared to Placebo	Baseline to Weeks 25 and 53
Proportion of Participants who Achieve Fasting TG <150 Milligrams per Deciliter (mg/dL) at Weeks 25 and 53 Compared to Placebo	Baseline, Weeks 25 and 53

Collaborators and Investigators

• Sponsor: Ionis Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2022
• Primary Completion (Actual): August 8, 2024
• Study Completion (Actual): June 9, 2025

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

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: ISIS 678354; Olezarsen
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Arteriosclerosis; Arterial Occlusive Diseases; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Atherosclerosis; Hypertriglyceridemia; olezarsen
• Other Study ID Numbers: ISIS 678354-CS9; 2022-501486-53 (EudraCT Number)

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
• product manufactured in and exported from the U.S.: No