AzTrials
AzTrials

Severe HypertriglyceridemiaPhase 3NCT05681351

CORE-OLE: A Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Participants With Severe Hypertriglyceridemia (SHTG)

A Phase 3 study testing Olezarsen in people with Severe Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 262 sites in 33 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Severe Hypertriglyceridemia
What is being tested?
Olezarsen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
885 participants
Where
262 sitesin 33 countries
Study dates
13 Dec 2022to Mar 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Satisfactory completion of either ISIS 678354-CS5 or ISIS 678354-CS6 with an acceptable safety profile, per Investigator judgment. Satisfactory completion requires that the patient did not terminate early from treatment.
  • Participants must be on a stable regimen of lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines. A patient may be eligible if their regimen of lipid-lowering therapy has been changed recently, provided that lipid lowering medications are optimized and stabilized for at least 4 weeks prior to the end of the Qualification Period of this OLE study; ideally, such changes are initiated after Week 53 of the index study (ISIS 678354-CS5 or CS6).
  • A patient may re-enroll in the study after having completed the study when the Treatment Period was 53 weeks, if the patient satisfactorily completed the study with an acceptable safety profile, per Investigator judgment. In the case of re-enrollment, there is no limit on the time gap between completion of treatment under the previous protocol and dosing upon re-enrollment (i.e., may exceed 17 weeks between doses).

Who cannot join

  • Have any new condition or worsening of existing condition which in the opinion of the Investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study, including need for treatment with disallowed medications, or need to change the required stable regimen as per either ISIS 678354-CS5 or ISIS 678354-CS6 study entry criteria. It is acceptable to adjust a regimen of lipid-lowering therapy as described in the second Key Inclusion Criterion above, and it is acceptable to adjust or stop lipid-lowering therapy at or after Week 13 per Investigator judgment.
  • NOTE: Other Inclusion/Exclusion criteria may apply.

Trial locations and contacts

262 sites in 33 countries.

262 sites in 33 countries

United States65 sites

  • University of Michigan- Endocrinology & Metabolism

    Ann Arbor, Michigan, 48109

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Grace Research, LLC

    Bossier City, Louisiana, 71111

  • Massachusetts General Hospital Heart Center

    Boston, Massachusetts, 02114

  • Modern Medical

    Brooklyn, New York, 33709

  • St. Vincent Medical Group, Inc.

    Carmel, Indiana, 46290

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Presbyterian Hospital DBA Novant Health Heart and Vascular Institute

    Charlotte, North Carolina, 28204

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404

  • Centricity Research

    Columbus, Georgia, 31904

  • IACT Health

    Columbus, Georgia, 31904

  • The Ohio State University

    Columbus, Ohio, 43203

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Central Oklahoma Early Detection Center

    Edmond, Oklahoma, 73034

  • Aa Mrc, Llc

    Flint, Michigan, 48504

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Kenneth Hilty

    Greensboro, North Carolina, 27401

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Juno Research

    Houston, Texas, 77040

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • The Jackson Clinic

    Jackson, Tennessee, 38301

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • Sante Clinical Research LLC

    Kerrville, Texas, 78028

  • FMC Science

    Lampasas, Texas, 76550

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89128

  • Clinical Trials of America, LLC

    Lenoir, North Carolina, 28645

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • Bryan Medical Center

    Lincoln, Nebraska, 68506

  • Walker Family Care

    Little River, South Carolina, 29566

  • LA Universal Research Center, Inc.

    Los Angeles, California, 90057

  • Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky, 40213

  • Manassas Clinical Research

    Manassas, Virginia, 20110

  • DCT- McAllen Primary Care, LLC

    McAllen, Texas, 78503

  • Texas Institute of Cardiology

    McKinney, Texas, 75071

  • SMS Clinical Research, LLC

    Mesquite, Texas, 75149

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Columbus Clinical Services, LLC

    Miami, Florida, 33125

  • Finlay Medical Research

    Miami, Florida, 33126

  • NYU Langone Health

    Mineola, New York, 11501

  • Innovia Research Center, Inc.

    Miramar, Florida, 33027

  • WVU Heart and Vascular Institute

    Morgantown, West Virginia, 26506

  • Langone Medical Center

    New York, New York, 10016

  • Vagelos College of Physicians and Surgeons of Columbia University

    New York, New York, 10032

  • York Clinical Research

    Norfolk, Virginia, 23510

  • Harmony Clinical Research, Inc.

    North Miami Beach, Florida, 33162

  • Affinity Health

    Oak Brook, Illinois, 60523

  • Permian Research Foundation

    Odessa, Texas, 79761

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19014

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • University of California, San Diego (UCSD)

    San Diego, California, 92161

  • Washington School of Medicine

    St Louis, Missouri, 63110

  • R & B Medical Center LLC

    Tampa, Florida, 33614

  • VICIS Clinical Research

    Tampa, Florida, 33615

  • JSV Clinical Research Study, Inc.

    Tampa, Florida, 33634

  • Metabolic Institute of America

    Tarzana, California, 91356

  • IRC Clinics

    Towson, Maryland, 21204

  • Bayside Clinical Research

    Trinity, Florida, 34655

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104

  • Hudson County Clinical Trials Research Center

    Union City, New Jersey, 07087

  • Tranquil Clinical and Research Consulting Services

    Webster, Texas, 77598

  • Lexington

    Winston-Salem, North Carolina, 27103

Other trials in United States

Bulgaria26 sites

  • MHAT- Blagoevgrad AD

    Blagoevgrad, 2700

  • Medical Center Doctor Staykov EOOD

    Burgas, 8000

  • Medical Center Diamedical 2013 OOD

    Dimitrovgrad, 6400

  • MHAT

    Gabrovo, 5300

  • MHAT Haskovo AD

    Haskovo, 6300

  • Multiprofile Hospital for Active Treament Pazardzhik, Cardiology Department

    Pazardzhik, 4400

  • SBAL "Special Medic" Ltd.

    Plovdiv, 4000

  • UHMAT Kaspela Ltd

    Plovdiv, 4001

  • University Multiprofile Hospital for Active Treatment Pulmed, Clinic of Endocrinology

    Plovdiv, 4002

  • Medical Center Rusemed EOOD

    Rousse, 7000

  • UMHAT Kanev AD

    Rousse, 7002

  • DCC-1 Sliven Ltd.

    Sliven, 8800

  • Medical Center Smolyan Clinical Research OOD

    Smolyan, 4700

  • Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

    Sofia, 1000

  • UMHAT Tsaritsa Yoanna ISUL- Clinic of Cardiology

    Sofia, 1527

  • Medical Center Endomedical

    Sofia, 1606

  • Medical Center Kalimat EOOD

    Sofia, 1680

  • MC Doctor Kalchev OOD

    Sofia, 1700

  • Medical Centre Synexus Sofia

    Sofia, 1784

  • UMHAT Sofiamed

    Sofia, 1797

  • MHAT Silven to MMA Sofia

    Sofia, 8800

  • Clinical of Cardiology

    Stara Zagora, 6003

  • Medical Center Zara-Med

    Stara Zagora, 6010

  • Diagnostic Consultative Center Equita (DCC Equita)

    Varna, 9000

  • Specialized Hospital for Active Treatment of Cardiology

    Varna, 9020

  • Medical Centre "Nevromedics" EOOD

    Veliko Tarnovo, 5006

Other trials in Bulgaria

Spain15 sites

  • Hospital Abente y Lago

    A Coruña, 15001

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic De Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellvitge

    Barcelona, 8907

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Corporacio Sanitaria Parc Tauli- Hospital de Sabadell

    Sabadell, 08208

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Universitari Sant Joan de Reus

    Tarragona, 43204

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Czechia12 sites

  • MEDICUS SERVICES s.r.o.

    Brandýs nad Labem, 250 01

  • University Hospital Hradec Králové

    Hradec Králové, 50005

  • KardioBusak s.r.o.

    Louny, 440 01

  • EDUMED s.r.o.

    Náchod, 547 01

  • Fakultni nemocnice Ostrava

    Ostrava, 70852

  • Vseobecna fakultni nemocnice

    Prague, 128 08

  • Fakultni Nemocnice v Motole

    Prague, 15006

  • Praha Poliklinika Hurka

    Prague, 158 00

  • Endokrinologie Cerny Most s.r.o.

    Prague, 19800

  • Milan Kvapil s.r.o.

    Příbram, 261 01

  • AeskuLab k.s

    Teplice, 415 01

  • MU Dr. Nina Zemkova s.r.o. Interni Ambulance

    Uherské Hradiště, 686 01

Other trials in Czechia

Poland11 sites

  • Uniwersytecki Centrum Kliniczne, I Klinika Kardiologii

    Gdansk, 80-952

  • Biokinetica Spolka Akcujna

    Józefów, 05-410

  • Centrum Medyczne Salvia

    Katowice, 40-772

  • Instytut Centrum Zdrowia Matki Polki

    Lodz, 93-338

  • Clinical Best Solutions

    Lublin, 20-078

  • ETG Lublin

    Lublin, 20-412

  • Centrum Zdrowia Metabolicznego Pawel Bogdanski

    Poznan, 60-589

  • Osrodek Badan Klinicznych Metabolica

    Tarnów, 33-100

  • Clinical Best Solutions Sp. z.o.o. Spolka Komandytowa

    Warsaw, 02-793

  • Przychodnia Futuremeds Wroclaw

    Wroclaw, 50-088

  • ETG Zamosc

    Zamość, 22-400

Other trials in Poland

Netherlands10 sites

  • Academic Medical Center

    Amsterdam, 1105AZ

  • Gelre Ziekenhuizen

    Apeldoorn, 7334 DZ

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • Het Van Weel-Bethesda Ziekenhuis

    Dirksland, 3247 BW

  • Ziekenhuis Gelderse Vallei

    Ede, 1001-5000

  • Bethesda Diabetes Research Center

    Hoogeveen, 7909 AA

  • Radboud UMC

    Nijmegen, 6525 EX

  • Erasmus MC

    Rotterdam, 3015 GD

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Albert Schweitzer Ziekenhuis

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

Slovakia10 sites

  • Ambulancia diabetologicka a poruch latkovej premeny a vyzivy

    Bratislava, 831 06

  • Kardiologická ambulancia

    Brezno, 97701

  • Cardio D&R, S.R.O. Kosice

    Košice, 040 22

  • Human-Care s.r.o.

    Košice, 04001

  • Vychodoslovensky Utsav srdcovych a cievnych chorob a.s.

    Košice, 04011

  • Interna a diabetologicka ambulancia- IN- DRA- s.r.o.

    Lučenec, 984 01

  • Diab sro

    Rožňava, 048 01

  • Interna SK, s.r.o., Kardiologicka a interna ambulancia

    Svidník, 08901

  • Nemocnica arm. generala L. Svobodu Svidnik, a.s

    Svidník, 08901

  • Areteus sro

    Trebišov, 075 01

Other trials in Slovakia

France9 sites

  • Louis Pradel Hospital

    Bron, 69500

  • Chu Dijon Bourgogne

    Dijon, 21079

  • Hôpitaux de Marseille

    Marseille, 13005

  • Hopital Lapeyronie

    Montpellier, 34295

  • AP-HP Hopital Pitie-Salpetriere

    Paris, 75013

  • CHU de Nantes - Hôpital Nord Laennec

    Saint-Herblain, 44093

  • CHRU de Strasbourg

    Strasbourg, 67200

  • Groupement de Cooperation Sanitaire (GCS) ESLAN - Polyclinique Vauban

    Valenciennes, 59300

  • GHM les Portes du Sud

    Vénissieux, 69200

Other trials in France

United Kingdom9 sites

  • Waterloo Medical Care

    Blackpool, FY4 3AD

  • Huddersfield Royal Infirmary

    Huddersfield, England, HD3 3EA

  • Hull Royal Infirmiry

    Hull, HU3 2JZ

  • Oak Tree Surgery and Pensilva Health Centre

    Liskeard, PL14 3XA

  • Manchester University NHS Foundation Trust

    Manchester, M13 9WL

  • Newquay Health Centre

    Newquay, TR7 1RQ

  • The Adam Practice

    Poole, BH16 5PW

  • Sandwell and West Birmingham NHS Trust

    West Bromwich, B71 4HU

  • Centre for Diabetes, Endocrinology and Metabolic Disease

    Woodhurst, Chatsworth, 4092

Other trials in United Kingdom

Hungary8 sites

  • Lausmed Kft

    Baja, 6500

  • DRC Gyógyszervizsgáló Központ Korlátolt felelősségű társaság Balatonfüred

    Balatonfüred, 8230

  • Obudai Egeszsegugyyi Centrum

    Budapest, H-1063

  • Debreceni Egyetem Klinikai Központ

    Debrecen, 4032

  • Rakoczi Ferenc Korhaz

    Miskolc, H-3529

  • Dr. Vasas Szilard Haziorvosi Rendelo

    Nyíregyháza, 4405

  • Kardiologia Szakrendeles

    Nyíregyháza, H-4400

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

Other trials in Hungary

Israel8 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Bnai Zion Medical Center

    Haifa, 3104802

  • The Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Rabin Medical Center

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

Other trials in Israel

Italy8 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXII

    Bergamo, 24127

  • Policlinico di Sant'Orsola

    Bologna, 40138

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione "Sant' Anna e San Sebastiano" di Caserta

    Caserta, 81100

  • Ospdale E. Bassini

    Milan, 20092

  • Asst Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliera Universitaria Policlinico

    Palmero, 90127

  • Department of Translational and Precision Medicine

    Rome, 00161

Other trials in Italy

Brazil7 sites

  • Centro Especializado em Cardiologia

    Campinas, 13010-001

  • Nucleo de Pesquisa Clinica S/S

    Curitiba, 80730-150

  • Hospital Universitario Walter Cantidio- UFC

    Fortaleza, 60430-270

  • Nucleo de Pasquisa em Cirurgia Vascular

    Porto Alegre, 90035-903

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- FMUSP

    São Paulo, 05403-000

  • Instituto do Coracao (InCor) do Hospital das Clinicas da FMUSP

    São Paulo, CEP-05403-000

  • CPQuali Pesquisa Clinica Ltda.

    São Paulo, SP-01228-00

Other trials in Brazil

Argentina6 sites

  • CIPREC

    Buenos Aires, C1061

  • Fundacion Favaloro

    Buenos Aires, C1093AAS

  • Centro Medico Dra. Laura Maffei-Investigacion Clinica Aplicad

    Buenos Aires, C1425AGC

  • Glenny Corp SA

    Buenos Aires, C1430CKE

  • Instituto Medico DAMIC

    Córdoba, X5003DCE

  • Clinica FUSAVIM Privada

    Villa María, X5900JKA

Other trials in Argentina

Canada6 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Institut de Recherches Cliniques de Montreal

    Montreal, H2W 1T7

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec, G1V 4W2

  • Bluewater Clinical Research Group, Inc.

    Sarnia, Ontario, N7T 4X3

  • Canadian Phase Onward Inc.

    Toronto, Ontario, M3J2C5

  • Toronto General Hospital

    Toronto, M4C 3E7

Other trials in Canada

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • Monash Medical Centre

    Clayton, 3168

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065

  • Dr Heart Pty Ltd

    Woolloongabba, 4102

Other trials in Australia

Portugal5 sites

  • Hospital Infante D. Pedro

    Aveiro, 3814-501

  • Hospital COF Tejo

    Lisbon, 1350-352

  • Hospital CUF Tejo

    Lisbon, 1350-352

  • Centro Hospitalar Universitario De Sao Joao

    Porto, 4200-319

  • Centro Hospitalar de Entre o Douro e Vouga, E.P.E.

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Taiwan5 sites

  • Kaohsiung Medical University Ching-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Mackay Memorial Hospital

    New Taipei City, 25160

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704

  • Shing Kong Wu Ho-Su Memorial Hospital

    Taipei, 111

Other trials in Taiwan

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus Universitet Hospital

    Aarhus, 8200

  • Esbjerg Hospital

    Esbjerg, 6700

  • Viborg Regional Hospital

    Viborg, 8800

Other trials in Denmark

Germany4 sites

  • Charite- Universitaetsmedizin Berlin

    Berlin, 13353

  • Universitaetsklinikum Koeln

    Cologne, 50937

  • Universitaetsklinikum Carl Gustav Carus

    Dresden, 1307

  • Forschungszentrum Ruhr

    Witten, 58455

Other trials in Germany

South Africa4 sites

  • Latros International

    Bloemfontein, 9301

  • Medi Clinic Vergelegen

    Cape Town, 7130

  • TREAD Research

    Cape Town, 7500

  • University of Cape Town

    Cape Town, 7700

Other trials in South Africa

Belgium3 sites

  • Universite Libre de Brussels (ULB)- Hopital Erasme

    Brussels, 1070

  • Jessa Ziekenhuis

    Hasselt, 3500

  • Universitaire Ziekenhuizen Leuven

    Leuven, 3000

Other trials in Belgium

Lithuania3 sites

  • Klinikiniai Sprendimai, UAB

    Kaunas, 49387

  • Saules Seimos Medicinos Centras

    Kaunas, 49456

  • Kardiologijos ir reabilitacijos klinika, UAB

    Klaipėda, 91131

Other trials in Lithuania

Mexico3 sites

  • Scientia Investigacion Clinical Sc

    Chihuahua City, 31207

  • Clinstile, S.A. de C.V.

    Mexico City, 06700

  • Centro de Investigacion Cardiometabolica S.C.

    Mexico City, 20230

Other trials in Mexico

Turkey (Türkiye)3 sites

  • Ege University School of Medicine, Department of Cardiology

    Izmir, 35040

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi

    Konya, 42080

  • Hacettepe Üniversitesi Tıp Fakültesi

    Sulhiye, 06100

Other trials in Turkey (Türkiye)

Greece2 sites

  • Evangelismos General Hospital Athens

    Athens, 106 76

  • Hygeia Hospital

    Athens, 15123

Other trials in Greece

India2 sites

  • Vinaya Hospital and Research Centre

    Mangalore, 575003

  • Sir Ganga Ram Hospital

    New Delhi, 110060

Other trials in India

Malaysia2 sites

  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, 59100

  • Pulau Pinang Hospital

    Pulau Pinang, 10990

Other trials in Malaysia

New Zealand2 sites

  • New Zealand Clinical Research

    Auckland, 8011

  • Edgar Diabetes and Obesity Research Centre

    Wellington, 6021

Other trials in New Zealand

Sweden2 sites

  • Sahlgrenska, University Hospital

    Gothenburg, 413 45

  • Karolinska University Hospital Huddinge

    Stockholm, 14186

Other trials in Sweden

Finland1 site

  • Turku University Hospital

    Turku, 20520

Other trials in Finland

Norway1 site

  • The Lipid Clinic (Oslo University Hospital)

    Oslo, 424

Other trials in Norway

Romania1 site

  • Cardioplus Center SRL

    Baia Mare, 430123

Other trials in Romania

About this study

Official title: An Open-Label Extension Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients With Severe Hypertriglyceridemia (SHTG)

The purpose of this study is to evaluate the safety and tolerability of olezarsen in participants with SHTG.

Read the detailed description

This is a multi-center, open-label extension (OLE) study of approximately 800 participants with SHTG who would be rolled over from studies ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326). Day 1 of this study may be same as the Week 53 visit of either ISIS 678354-CS5 or ISIS 678354-CS6, as applicable. Participants will receive olezarsen during the 157-week treatment period. The study will include a 31-day qualification Period, a 157-week treatment period, and a 13-week post-treatment period.

Being tested
Olezarsen
Keywords
ISIS 678354, Olezarsen
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OlezarsenDrug

    Also called AKCEA-APOCIII-LRx, ISIS 678354

    Administered as SC injection.

Study groups in NCT05681351
Study groupRoleWhat they receive
OlezarsenExperimentalParticipants who completed either ISIS 678354-CS5 (NCT05079919) or ISIS 678354-CS6 (NCT05552326) study would be enrolled to receive olezarsen, subcutaneous (SC) injection, once every 4 weeks from Week 1 through Week 153.
Receives: Drug: Olezarsen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157

    Measured: Baseline up to Week 157

  2. Proportion of Participants Who Experience Adverse Events (AEs)

    Measured: Baseline up to Week 157

  3. Proportion of Participants Who Use Concomitant Medications

    Measured: Baseline up to Week 157

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2023
  2. Study start13 Dec 2022
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
885 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05681351
Sponsor's protocol ID
ISIS 678354-CS15
Other IDs
2022-501999-26-00
Status last verified
Nov 2025
First submitted
25 Dec 2022
Last updated
1 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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/.
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olezarsen in people with Severe Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 262 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 262 sites in United States, Bulgaria, Spain, Czechia, Poland and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With Change in Clinical Laboratory Values From Baseline to Week 53, From Baseline to Week 105, and From Baseline to Week 157 (time frame: Baseline up to Week 157). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05681351.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.

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