A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

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

The purpose of this 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: Severe Hypertriglyceridemia
• Intervention / Treatment: Drug: Olezarsen; Drug: Placebo

Detailed Description

This is a Phase 3, multi-center, randomized, double-blind, placebo-controlled study in 446 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): 446
• Phase: Phase 3

Expanded Access

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

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1093AAS
    • Fundacion Favaloro
  • Buenos Aires, Argentina, C1425AGC
    • Centro Médico Dra. Laura Maffei
  • Buenos Aires, Argentina, C1430
    • Glenny Corp SA
  • Buenos Aires, Argentina, C1061AAG
    • Ciprec - Centro de Investigacion y Prevencion Cardiovascular
  • Corrientes, Argentina, W3400CDS
    • Instituto de Cardiología Corrientes
  • Córdoba, Argentina, X5003DCE
    • Instituto Medico DAMIC
  • San Luis, Argentina, D5700
    • Centro Medico San Luis
  • Villa María, Argentina, X5900JKA
    • Clinica FUSAVIM Privada
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint-Jan Brugge
  • Brussels, Belgium, 1070
    • Hopital Erasme
  • Hasselt, Belgium, 3500
    • Virga Jessa Hospital
  • Leuven, Belgium, 3000
    • UZ Leuven
• Brazil
  • Belo Horizonte, Brazil, 30220-140
    • NUPEC - Nucleo de Pesquisa Clinica
  • Curitiba, Brazil, 80730-150
    • Núcleo de Pesquisa Clinica
  • Fortaleza, Brazil, 60430-270
    • Hospital Universitário Walter Cantídio - UFC
  • Porto Alegre, Brazil, 90035-903
    • Núcleo de Pesquisa em Cirurgia Vascular
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin Pesquisa Clinica
  • São Paulo, Brazil, 01228-000
    • CPQuali Pesquisa Clínica
  • São Paulo, Brazil, 05403-000
    • Instituto do Coracao - HCFMUSP
  • São Paulo, Brazil, 13092-133
    • i9 Pesquisas Clínicas/Loema - Instituto de Pesquisas Clínica & Consultores
  • São Paulo, Brazil, 05403-900
    • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo - FMUSP
• Bulgaria
  • Dimitrovgrad, Bulgaria, 6400
    • Medical Center Diamedical EOOD
  • Haskovo, Bulgaria, 6304
    • MHAT Haskovo AD
  • Pazardzhik, Bulgaria, 4400
    • MHAT Pazardzhik AD
  • Plovdiv, Bulgaria, 4000
    • University Multiprofile Hospital for Active Treatment Pulmed OOD
  • Plovdiv, Bulgaria, 4000
    • UMHAT - Kaspela EOOD
  • Rousse, Bulgaria, 7002
    • UMHAT Kanev AD
  • Sliven, Bulgaria, 8800
    • MHAT Sliven to MMA Sofia
  • Smolyan, Bulgaria, 4700
    • Medical center Smolyan clinical research OOD
  • Sofia, Bulgaria, 1784
    • Medical Centre Synexus Sofia EOOD
  • Sofia, Bulgaria, 1000
    • Medical Center For Specialized Medical Help In Cardiovascular Diseases OOD
  • Sofia, Bulgaria, 1527
    • Medico Dental Center ISUL Tsaritsa Yoanna EOOD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda University Hospital
  • Stara Zagora, Bulgaria, 6000
    • Medical Center Zara - Med
  • Varna, Bulgaria, 9000
    • DCC Equita
  • Varna, Bulgaria, 9000
    • Specialized Hospital for Active Treatment of Cardiology
  • Veliko Tarnovo, Bulgaria, 5006
    • Medical Centre "Nevromedics" EOOD
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • NL Health Services
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Aggarwal and Associates Ltd.
    • Cambridge, Ontario, Canada, N3H 4L5
      • Joanne F. Liutkus Medicine Professional Corporation
    • Sarnia, Ontario, Canada, N7T 4X3
      • Bluewater Clinical Research Group
    • Toronto, Ontario, Canada, M5G2C4
      • Toronto General Hospital
  • Quebec
    • Saint-Jérôme, Quebec, Canada, J7Z 2V4
      • Unite de Recherche Clinique
• Czechia
  • Hodonín, Czechia, 695 01
    • CTC Hodonin s.r.o.
  • Louny, Czechia, 440 01
    • KardioBusak s.r.o.
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 198 00
    • Endokrinologie Cerny Most s.r.o.
  • Příbram, Czechia, 267 01
    • Diabetologická a endokrinologická ambulance Milan Kvapil
  • Teplice, Czechia, 415 01
    • AeskuLab k.s
• France
  • Strasbourg, France, 67098
    • Hopital de Hautepierre
  • Valenciennes, France, 59300
    • ELSAN - Polyclinique Vauban
  • Vénissieux, France, 69200
    • GHM les Portes du Sud
• Greece
  • Alexandroupoli, Greece, 68100
    • University General Hospital of Alexandroupoli
  • Athens, Greece, 15123
    • Hygeia Hospital
  • Athens, Greece, 12462
    • University General Hospital Attikon
  • Athens, Greece, 10676
    • AHEPA Building of Evaggelismos
  • Thessaloniki, Greece, 54636
    • Ahepa University General Hospital of Thessaloniki
• Hungary
  • Baja, Hungary, H-6500
    • Lausmed Kft.
  • Balatonfüred, Hungary, H-8230
    • DRC Gyogyszervizsgalo Kozpont Kft
  • Budapest, Hungary, H-1036
    • Óbudai Egészségügyi Centrum
  • Budapest, Hungary, H1033
    • Clinexpert Kft.
  • Gyöngyös, Hungary, H-3200
    • Pharma4 Trial Kft.
  • Kaposvár, Hungary, H-7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz Diabetologiai szakrendeles
• India
  • Bengaluru, India, 560069
    • Sri Jayadeva Institute of Cardiovascular Sciences and Research
  • Delhi, India, 110060
    • Sir Ganga Ram Hospital
  • Jaipur, India, 302017
    • Eternal Hospital
  • Kolkata, India, 700020
    • IPGMER
  • Mangaluru, India, 575003
    • Vinaya Hospital and Research Centre (A Unit of Karnataka Institute of Medical Sciences)
  • Mumbai, India, 400007
    • Bhatia Hospital
  • Mumbai, India, 4000012
    • KEM Hospital
  • Mysore, India, 570015
    • Manipal Hospital Mysore
  • National Capital Territory of Delhi
    • New Delhi, National Capital Territory of Delhi, India, 110017
      • MAX Super Specialty Hospital
  • West Bengal
    • Kolkata, West Bengal, India, 700027
      • B. M. Birla Heart Research Centre A Unit of the Calcutta Medical Research Institute
• Italy
  • Bergamo, Italy, 24127
    • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
  • Caserta, Italy, 81100
    • AORN S. Anna e S. Sebastiano UOC FARMACIA
  • Cona, Italy, 44124
    • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
  • Pavia, Italy, 27100
    • Fondazione I.R.C.C.S. Policlinico "San Matteo" c/o C.U.R.M.
• Lithuania
  • Kaunas, Lithuania, 49449
    • Saules seimons medicinos centras
  • Kaunas, Lithuania, LT-49387
    • Klinikiniai sprendimai
  • Klaipėda, Lithuania, LT-91131
    • Clinic of Cardiology and Rehabilitation
  • Panevezys, Lithuania, LT-35144
    • Republican Panevezys Hospital
  • Šiauliai, Lithuania, LT-76206
    • Pirmoji Viltis
• Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre (UMMC)
  • Kedah
    • Alor Star, Kedah, Malaysia, 05460
      • Sultanah Bahiyah Hospital
  • Perak
    • Taiping, Perak, Malaysia, 34000
      • Hospital Taiping
  • Pulau Pinang
    • George Town, Pulau Pinang, Malaysia, 10450
      • Pulau Pinang Hospital
• Mexico
  • Aguascalientes, Mexico, 20230
    • Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.
  • Chihuahua City, Mexico, 32103
    • Cientia Investigacion Clinica Sc
  • Mexico City, Mexico, 06700
    • Clinstile, S.A. de C.V.
  • Tlanepantla, Mexico, 54055
    • Clinical Research Institute S.C.
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Medical Care and Research S.A de C.V.
• Netherlands
  • Amsterdam, Netherlands, 1081BT
    • Vumc Amsterdam Medical Center
  • Apeldoorn, Netherlands, 7334 DZ
    • Gelre Ziekenhuizen Apeldoorn
  • Delft, Netherlands, 2625 AD
    • Reinier de Graaf Ziekenhuis
  • Dirksland, Netherlands, 3247BW
    • Het Van Weel Bethesda ziekenhuis
  • Dordrecht, Netherlands, 3318 AT
    • Albert Schweitzer Ziekenhuis
  • Hoogeveen, Netherlands, 7909 AA
    • Bethesda Diabetes Research Center
  • Nijmegen, Netherlands, 6532 SZ
    • Canisius-Wilhelmina Ziekenhuis (CWZ)
• Poland
  • Gdansk, Poland, 80-214
    • UCK, I Klinika Kardiologii
  • Józefów, Poland, 05-410
    • Biokinetica
  • Katowice, Poland, 40-081
    • Centrum Medyczne Pratia
  • Lodz, Poland, 91-053
    • Centra Medyczne Medyceusz
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Lublin, Poland, 20-078
    • Clinical Best Solutions
  • Poznan, Poland, 60-589
    • Centrum Zdrowia Metabolicznego
  • Warsaw, Poland, 00-710
    • Clinical Best Solutions Sp. z.o.o Spolka Komandytowa
  • Warsaw, Poland, 03-291
    • Centrum Medycnze AMED
  • Warsaw, Poland, 04-628
    • Narodowy Instytut Kardiologii im. S. Wyszyńskiego - PIB
  • Zamość, Poland, 22-400
    • ETG Zamosc / Pro Life Medica Sp. z o.o.
• Portugal
  • Lisbon, Portugal, 1350-352
    • Hospital Cuf Tejo
  • Santa Maria da Feira, Portugal, 4520-211
    • Centro Hospitalar de Entre Douro e Vouga
• Romania
  • Alba, Romania, 510053
    • Cabinet Medical Individual SC DIANA BARBONTA SRL
  • Baia Mare, Romania, 430123
    • Cardioplus Center SRL
  • Brasov, Romania, 500283
    • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L
  • Bucharest, Romania, 10626
    • Centrul Medical Medicover Victoria
  • Piteşti, Romania, 10437
    • S.C. SAL MED S.R.L., Cardiologie
  • Târgu Mureş, Romania, 540124
    • Cardio Med SRL
  • Târgu Mureş, Romania, 540142
    • S.C. Mediab Srl
• Slovakia
  • Bardejov, Slovakia, 08501
    • Alian s.r.o.
  • Bratislava, Slovakia, 83106
    • Ambulancia diabetologicka a poruch latkovej premeny a vyzivy
  • Lučenec, Slovakia, 98401
    • Interna a diabetologicka ambulancia - IN-DIA s.r.o.
  • Rožňava, Slovakia, 04801
    • DIAB sro
  • Svidník, Slovakia, 08901
    • Interna SK, s.r.o.
  • Trebišov, Slovakia, 07501
    • Areteus s.r.o
• Spain
  • Badalona, Spain, 8916
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 8035
    • Hospital Vall d'Hebron
  • Huelva, Spain, 21007
    • Hospital Comarcal Infanta Elena
  • Jaén, Spain, 23007
    • Hospital Universitario de Jaén
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Málaga, Spain, 29009
    • Hospital Regional de Malaga
  • Málaga, Spain, 29010
    • Unidad de Ensayos Clinicos
  • Santiago de Compostela, Spain, 15706
    • Hospital Provincial de Conxo
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Zaragoza, Spain, 50009
    • Hospital Universitario Miguel Servet
• Sweden
  • Solna, Sweden, SE-171 64
    • Acardo MedSite
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
  • New Taipei City, Taiwan, 251404
    • Mackay Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Tainan City, Taiwan, 704017
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 111045
    • Shin Kong Wu Ho-Su Memorial Hospital
  • Taoyuan District, Taiwan, 33305
    • Chang Gung Medical Foundation - Linkou Branch
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc.
    • Birmingham, Alabama, United States, 35235
      • Alabama Clinical Therapeutics, LLC Alabaster
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Onyx Clinical Research
  • California
    • Los Angeles, California, United States, 90015
      • NRC Research Institute
  • Florida
    • DeLand, Florida, United States, 32720
      • Accel Research Sites
    • Greenacres City, Florida, United States, 33467
      • Finlay Medical Research
    • Jacksonville, Florida, United States, 32209
      • University of Florida Jacksonville
    • Maitland, Florida, United States, 32751
      • Meridien Research
    • Miami, Florida, United States, 33125
      • Columbus Clinical Services
    • North Miami Beach, Florida, United States, 33162
      • Harmony Clinical Research, Inc
    • Orlando, Florida, United States, 32807
      • Combined Research Orlando Phase I-IV
    • Sunrise, Florida, United States, 33325
      • 3Sync Research
    • Tampa, Florida, United States, 33634
      • JSV Clinical Research Study, Inc.
    • Tampa, Florida, United States, 33614
      • R & B Medical Center LLC
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Eatonton, Georgia, United States, 31024
      • Accel Clinical Research
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
    • Newnan, Georgia, United States, 30265
      • Randomize Now
  • Indiana
    • Carmel, Indiana, United States, 46290
      • St. Vincent Medical Group
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center (KUMC)
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • The Research Group of Lexington, LLC
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
    • Louisville, Kentucky, United States, 40213
      • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Grace Research, LLC
    • Monroe, Louisiana, United States, 71201
      • Clinical Trials of America LA, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
    • Baltimore, Maryland, United States, 21229
      • Maryland Cardiovascular Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Flint, Michigan, United States, 48532
      • Onyx Clinical Research
    • Rochester Hills, Michigan, United States, 48307
      • Onyx Clinical Research
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Stern Cardiovascular
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Hospital - Long Island
    • Orchard Park, New York, United States, 14127
      • Orchard Park Family Practice
  • North Carolina
    • Lenoir, North Carolina, United States, 28645
      • Clinical Trials of America, LLC
    • Morehead City, North Carolina, United States, 28557
      • Diabetes and Endocrinology Consultants, P.C.
    • Salisbury, North Carolina, United States, 28144
      • OnSite Clinical Solutions, LLC
  • Ohio
    • Columbus, Ohio, United States, 43203
      • The Ohio State University (OSU)
    • Marion, Ohio, United States, 43302
      • SV Research LLC
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Oklahoma Heart Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)
    • Little River, South Carolina, United States, 29566
      • Main Street Physicians Care Waterway
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Monument Health Clinical Research
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Fort Worth, Texas, United States, 76107
      • Texas Health Family Care
    • Houston, Texas, United States, 77017
      • Vilo Research Group
    • Houston, Texas, United States, 77040
      • Juno Research
    • Houston, Texas, United States, 77054
      • Juno Research
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Houston, Texas, United States, 77099
      • Pioneer Research Solutions, Inc
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research, LLC
    • Lampasas, Texas, United States, 76550
      • FMC Science
    • McAllen, Texas, United States, 78503
      • DCT - McAllen Primary Care, LLC
    • McKinney, Texas, United States, 75071
      • Texas Institute of Cardiology
    • Mesquite, Texas, United States, 75149
      • Southern Endocrinology Associates
    • Mesquite, Texas, United States, 75149
      • SMS Clinical Research, LLC
    • Odessa, Texas, United States, 79761
      • Permian Research Foundation
    • San Antonio, Texas, United States, 78229
      • Diabetes & Glandular Disease Clinic, P.A.
    • Webster, Texas, United States, 77598
      • Tranquil Research
  • Utah
    • Orem, Utah, United States, 84058
      • Aspen Clinical Research
    • Roy, Utah, United States, 84401
      • Ogden Clinic Grandview
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144
      • Clinical Investigation Specialists Inc.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification
2. Participants 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.
3. Participants must be willing to comply with diet and lifestyle recommendations as able.

Exclusion Criteria:

1. Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening
2. Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal
3. Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome
4. Estimated GFR < 30 mL/min/1.73 m^2

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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 subcutaneous (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	Baseline and Month 6

Secondary Outcome Measures

Outcome Measure	Time Frame
Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo	Week 1 through Week 53
Percent Change from Baseline in Fasting TG Compared to Placebo	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	Baseline, Month 6 and 12
Proportion of Patients Who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo	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	Month 12
Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Pooled Placebo	Baseline through Month 12

Collaborators and Investigators

• Sponsor: Ionis Pharmaceuticals, Inc.

Publications and helpful links

General Publications

• Marston NA, Bergmark BA, Alexander VJ, Karwatowska-Prokopczuk E, Kang YM, Moura FA, Prohaska TA, Zimerman A, Zhang S, Murphy SA, Tsimikas S, Giugliano RP, Sabatine MS. Design and rationale of the CORE-TIMI 72a and CORE2-TIMI 72b trials of olezarsen in patients with severe hypertriglyceridemia. Am Heart J. 2025 Aug;286:125-135. doi: 10.1016/j.ahj.2025.03.003. Epub 2025 Mar 9.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Actual): December 17, 2024
• Study Completion (Actual): September 12, 2025

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Metabolic Diseases; Hypertriglyceridemia; Hyperlipidemias
• Additional Relevant MeSH Terms: Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Metabolic Diseases; Hypertriglyceridemia; Hyperlipidemias; olezarsen
• Other Study ID Numbers: ISIS 678354-CS6; 2022-501420-20 (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