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Severe HypertriglyceridemiaPhase 3NCT05079919

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

A Phase 3 study testing Olezarsen in people with Severe Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 209 sites in 23 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. 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?
Yes, some participants may receive a placebo
How many people
617 participants
Where
209 sitesin 23 countries
Study dates
25 Oct 2021to 8 Jul 2025
Phase
Phase 3
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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

Trial locations and contacts

209 sites in 23 countries.

209 sites in 23 countries

United States56 sites

  • University of Michigan Hospital and Health Systems/ Dept. of Pharmacy-Research Pharmacy

    Ann Arbor, Michigan, 48109

  • Accel Research Sites Network

    Birmingham, Alabama, 35216

  • Excel Medical Clinical Trials, LLC

    Boca Raton, Florida, 33434

  • Modern Medicine

    Brooklyn, New York, 11235

  • Velocity Clinical Research

    Cedar Park, Texas, 78613

  • Novant Health Cancer Institute Elizabeth Investigational Drug Services

    Charlotte, North Carolina, 28204

  • Chattanooga Research & Medicine, PLLC

    Chattanooga, Tennessee, 37404

  • IMA Clinical Research Chicago

    Chicago, Illinois, 60602

  • Southeast Clinical Research LLC

    Chiefland, Florida, 32626

  • Velocity Clinical Research

    Chula Vista, California, 91911

  • IACT Health

    Columbus, Georgia, 31904

  • Aventiv Research

    Columbus, Ohio, 43213

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Aa Mrc, Llc

    Flint, Michigan, 48504

  • Northwell Health

    Great Neck, New York, 11021

  • Cone Medical Center

    Greensboro, North Carolina, 27401

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Diabetes/Lipid Management & Research Center

    Huntington Beach, California, 92648

  • Westside Center for Clinical Research

    Jacksonville, Florida, 32205

  • Kansas University Medical Center

    Kansas City, Kansas, 66160

  • University of California, San Diego (UCSD)

    La Jolla, California, 92037

  • Palm Research Center, INC.

    Las Vegas, Nevada, 89148

  • Bryan Medical Center Clinical Research

    Lincoln, Nebraska, 68506

  • LA Universal Research Center, Inc.

    Los Angeles, California, 90057

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Velocity Clinical Research

    Medford, Oregon, 97504

  • Finlay Medical Research

    Miami, Florida, 33126

  • Circuit Clinical (Crystal Run Healthcare)

    Middletown, New York, 10941

  • Innovia Research Center, INC

    Miramar, Florida, 33027

  • Clinical Trials of America, LLC

    Monroe, Louisiana, 71201

  • West Virginia University Heart and Vascular Institute

    Morgantown, West Virginia, 26506

  • Clinical Trials of America, LLC

    Mount Airy, North Carolina, 27030

  • Summit Research Group, LLC

    Munroe Falls, Ohio, 44262

  • NYU Langone

    New York, New York, 10016

  • Columbia University

    New York, New York, 10032

  • Circuit Clinical

    Niagara Falls, New York, 14304

  • York Clinical Research LLC

    Norfolk, Virginia, 23510

  • Affinity Health

    Oak Brook, Illinois, 60523

  • Ocala Cardiovascular Research

    Ocala, Florida, 34471

  • Hightower Clinical Trial Services

    Oklahoma City, Oklahoma, 73102

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Wake Forest University Health Sciences

    Salem, North Carolina, 27157

  • Mayo Clinic

    Scottsdale, Arizona, 85259

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • IMA Clinical Research

    St Louis, Missouri, 63117

  • IMA Clinical Research

    St. Petersburg, Florida, 33709

  • Medicus Alliance Clinical Research

    Sugar Land, Texas, 77478

  • Modern Medical

    Syosset, New York, 11791

  • VICIS Clinical Research

    Tampa, Florida, 33614

  • America Clinical Trials

    Tarzana, California, 91356

  • Continental Clinical Solutions

    Towson, Maryland, 21204

  • Bayside Clinical Research

    Trinity, Florida, 34655

  • Hudson County Clinical Trials Research Center

    Union City, New Jersey, 07087

  • Velocity Clinical

    West Jordan, Utah, 84088

Other trials in United States

Bulgaria17 sites

  • MHAT Blagoevgrad AD

    Blagoevgrad, 2700

  • Medical Center Doctor Staykov EOOD

    Burgas, 8008

  • Medical Center Diamedical 2013 OOD

    Dimitrovgrad, 6400

  • MHAT "Dr. Tota Venkova" AD

    Gabrovo, 5300

  • Medical Center "Hera" EOOD

    Montana, 3400

  • SHAT "Special Medic" Ltd

    Plovdiv, 4000

  • Medical Center Rusemed EOOD

    Rousse, 7000

  • DCC 1 Sliven

    Sliven, 8800

  • Gabriela Zhelyazkova

    Sliven, 8800

  • Medical Center Smolyan Clinical Research OOD

    Smolyan, 4700

  • Medical Center Endomedical EOOD

    Sofia, 1606

  • Medical Centar "KALIMAT"

    Sofia, 1680

  • MC Doctor Kalchev OOD

    Sofia, 1700

  • UMHAT Sofiamed OOD

    Sofia, 1797

  • New Rehabilitation Center

    Stara Zagora, 6000

  • UMHAT Prof. Dr. Stoyan Kirkovich AD, Clinic of Cardiology

    Stara Zagora, 6000

  • Medical Centre Nevromedics EOOD

    Veliko Tarnovo, 5006

Other trials in Bulgaria

United Kingdom16 sites

  • Waterloo Medical Centre

    Blackpool, FY4 3AD

  • Lakeside Healthcare at Corby

    Corby, Northamptonshire, NN172UR

  • Mounts Bay Medical Hub

    Cornwell, TR27 5DT

  • Panthera

    Glasgow, G51 4TY

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Huddersfield Royal Infirmary

    Lindley, Huddersfield, HD3 3EA

  • Oak Tree Surgery and Pensilva Health Centre

    Liskeard, Cornwall, PL14 3XA

  • Panthera

    London, EN3 4GS

  • Sandwell General Hospital

    Lyne, West Bromwich, B71 4HJ

  • Manchester University NHS Foundation Trust (MFT)

    Manchester, M13 9WL

  • Newquay Health Centre

    Newquay, Cornwall, TR7 1RU

  • Upton Surgery

    Poole, Dorset, BH16 5PW

  • Panthera

    Preston, PR2 9QB

  • Panthera Biopartners

    Rochdale, England, OL11 4AU

  • Panthera Biopartners

    Sheffield, England, S2 5FX

  • Primary Care Sheffield

    Sheffield, S94EU

Other trials in United Kingdom

Hungary11 sites

  • CRU Hungary Kft

    Borsod, 3860

  • Észak-Pesti Centrumkórház - Honvédkórház; II. Belgyógyászati Osztály

    Budapest, H-1062

  • Semmelweis Egyetem Kardiológiai Rehabilitacio

    Budapest, H-1085

  • Belinus BT

    Debrecen, 4025

  • Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet

    Debrecen, 4032

  • BKS Research Kft

    Hatvan, Heves County, 3000

  • IPR Hungary Kft.

    Miskolc, H-3530

  • Medifarma 98 Kft

    Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400

  • Borbanya Praxis Eü KFT

    Nyíregyháza, 4405

  • Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Székesfehérvár, 8000

  • DRC Gyogyszervizsgalo Kozpont Kft

    Veszprém, 8230

Other trials in Hungary

Spain10 sites

  • Hospital Abente y Lago

    A Coruña, 15001

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, 08041

  • Hospital Clinic Barcelona

    Barcelona, 8063

  • Institut d'Investigació i Innovació Parc Taulí (I3PT) Departament Medicina Universitat

    Barcelona, 8208

  • Hospital Universitari de Bellvitge

    Barcelona, 8907

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario

    Madrid, 28041

  • Hospital Virgen del Rocio Edificio Centro de Diagnostico y Tratamiento (CDT)

    Seville, 41013

  • Hospital Universitari Sant Joan de Reus.

    Tarragona, 43204

Other trials in Spain

Germany9 sites

  • Stoffwechselcentrum Charite Campus Virchow

    Berlin, 13353

  • Uniklinik Köln

    Cologne, 50937

  • Universitaetsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 1307

  • Klinische Forschung Hamburg GmbH

    Hamburg, 20253

  • Klinische Forschung Hannover-Mitte GmbH

    Hanover, 30159

  • St. Josefskrankenhaus,

    Heidelberg, 69115

  • Praxis Dr. med. Taggeselle

    Markkleeberg, 04416

  • Kardiologische Praxis in Papenburg

    Papenburg, 26871

  • Evangelisches Krankenhaus Witten

    Witten, 58455

Other trials in Germany

Israel9 sites

  • SOROKA Medical Center

    Beersheba, 8410101

  • Bnai Zion Medical Center

    Haifa, 3339416

  • Lady Davis Carmel Medical Center

    Haifa, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Hebrew University Ein Kerm MC

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Kaplan Medical Center

    Rehovot, 7661041

  • Sourasky Medical Center

    Tel Aviv, 6423909

  • Sheba Medical Center

    Tel HaShomer, 5265601

Other trials in Israel

Czechia8 sites

  • MEDICUS SERVICES s.r.o.

    Brandýs nad Labem, 250 01

  • EDUMED s.r.o.

    Hradec Králové, 500 02

  • Fakultní nemocnice Hradec Králové

    Hradec Králové, 500-05

  • EDUMED s.r.o.

    Náchod, 547 01

  • Fakultni nemocnice Ostrava

    Ostrava, 70852

  • Vseobecna fakultni nemocnice

    Prague, 128 08

  • Lekarna Poliklinika Hurka

    Prague, 15800

  • Interni Ambulance

    Uherské Hradiště, 686 01

Other trials in Czechia

Denmark7 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8200

  • Esbjerg Hospital

    Esbjerg, 6700

  • Bispebjerg Hospital

    Frederiksberg, 2000

  • Herlev Hospital

    Herlev, 2730

  • Godstrup Regional Hospital

    Herning, 7400

  • Regionshospitalet Viborg

    Viborg, 8800

Other trials in Denmark

Italy7 sites

  • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di SantOrsola

    Bologna, 40138

  • Ospdale E. Bassini

    Milan, 20092

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • A.O. Policlinico Universitario P. Giaccone

    Palermo, 90127

  • Policlinico Umberto

    Roma, 00161

  • Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Roma, 00168

Other trials in Italy

Netherlands7 sites

  • Academic Medical Center - Department of Vascular Medicine

    Amsterdam, 1105 AZ

  • Rijnstate Arnhem

    Arnhem, 6815 AD

  • Albert Schweitzer ziekenhuis

    Dordrecht, 3318 AT

  • Ziekenhuis Gelderse Vallei

    Ede, 6716 RP

  • Radboud UMC

    Nijmegen, 6525 GA

  • Erasmus MC

    Rotterdam, 3015 GD

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton S., Victoria, 3168

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal North Shoe Hospital

    Saint Leonards, New South Wales, 2065

  • Dr. Heart Pty Ltd at Cholesterol Care Australia

    Woolloongabba, Queensland, 4102

Other trials in Australia

France6 sites

  • Hôpital Louis Pradel

    Bron, 69677

  • CHU Dijon Bourgogne

    Dijon, 21079

  • Hopital de la Conception

    Marseille, 13005

  • CHU Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • Hopital Pitie Salpetriere APHP

    Paris, 75013

  • CHU Nantes - Hopital Nord Laennec

    Saint-Herblain, 44093

Other trials in France

Poland6 sites

  • Salvia

    Katowice, 40-772

  • Instytut Centrum Zdrowia Matki Polki Klinika

    Łódz, 93-338

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan, 61-655

  • ClinMedica Research Sp.z o.o.

    Skierniewice, 96-100

  • Osrodek Badan Klinicznych Metabolica

    Tarnów, 33-100

  • Futuremeds sp. z o.o

    Wroclaw, 50-088

Other trials in Poland

Slovakia6 sites

  • Medispektrum s.r.o., diabetologicka a metabolicka ambulancia

    Bratislava, 851 01

  • Nemocnica s poliklinikou Brezno

    Brezno, 97701

  • Human-Care s.r.o.

    Košice, 040 01

  • Vychodoslovensky Ustav srdcovych a cievnych chorob a.s.

    Košice, 040 11

  • Cardio D&R

    Košice, 040 22

  • Nemocnica arm. generala L. Svobodu Svidnik,

    Svidník, 089 01

Other trials in Slovakia

South Africa6 sites

  • Iatros International

    Bloemfontein, Free State, 9301

  • Dr Jan Engelbrecht and Ass. Inc

    Cape Town, Western Cape, 7130

  • University of Cape town - Lipid Factory

    Cape Town, 7925

  • Unitas Hospital

    Centurion, Gauteng, 157

  • Chatsmed Garden Hospital

    Chatsworth, 4092

  • TREAD Research - Department of Cardiology

    Parow, Western Cape, 7500

Other trials in South Africa

Canada5 sites

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Institut de recherches cliniques de Montréal (IRCM)

    Montreal, Quebec, H2W 1R7

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec, G1V 4W2

  • Canadian Phase Onward Inc

    Toronto, Ontario, M3J 0K2

  • Arc Biosystems

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Portugal5 sites

  • Centro Hospitalar do Baixo Vouga Hospital Infante D. Pedro

    Aveiro, 3814-501

  • Centro Hospitalar e Universitário de Coimbra, EPE

    Coimbra, 3004-561

  • Hospital Egas Moniz - Centro Hospitalar de Lisboa Ocidental

    Lisbon, 1349-019

  • Centro Hospitalar Universitário de São João Consultas Externas de Endocrinologia K13

    Porto, 4200-319

  • Centro Hospitalar

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Turkey (Türkiye)4 sites

  • Hacettepe University Medical Faculty

    Ankara, 06230

  • Ege University School of Medicine, Department of Cardiology

    Izmir, 35100

  • Kocaeli University Faculty of Medicine

    Kocaeli, 41380

  • Necmettin Erbakan University Meram Medical Faculty

    Konya, 42280

Other trials in Turkey (Türkiye)

New Zealand3 sites

  • New Zealand Clinical Research

    Christchurch, 8011

  • Auckland City Hospital

    Grafton, Auckland, 1010

  • Wellington Regional Hospital

    Newtown, 6021

Other trials in New Zealand

Finland2 sites

  • Turku University Hospital

    Turku, 20520

  • Ylitornio Health Care Center

    Ylitornio, 95600

Other trials in Finland

Sweden2 sites

  • Sahlgrenska, University Hospital

    Gothenburg, Västra Götaland County, 413 45

  • Karolinska University Hospital Huddinge

    Stockholm, 14186

Other trials in Sweden

Norway1 site

  • Lipid Clinic

    Oslo, 0586

Other trials in Norway

About this study

Official title: 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.

Read the 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.

Being tested
Olezarsen, Placebo
Keywords
ISIS 678354, Fasting Triglycerides, Apolipoprotein C-III, Very Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein-Cholesterol, Non-High-Density Lipoprotein-Cholesterol, 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

    Olezarsen will be administered by SC injection.

  • PlaceboDrug

    Olezarsen-matching placebo will be administered by SC injection.

Study groups in NCT05079919
Study groupRoleWhat they receive
OlezarsenExperimentalOlezarsen will be administered once every 4 weeks by subcutaneous (SC) injection from Week 1 through Week 49.
Receives: Drug: Olezarsen
PlaceboPlacebo comparatorOlezarsen-matching placebo will be administered once every 4 weeks by SC injection from Week 1 through Week 49.
Receives: Drug: Placebo

What is being measured

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

  1. Percent Change from Baseline in Fasting TG Compared to Placebo

    Measured: Baseline and Month 6

Secondary outcomes (6)

  1. Percent Change from Baseline in Fasting TG Compared to Placebo

    Measured: Baseline and Month 12

  2. 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

    Measured: Baseline, Month 6 and 12

  3. Proportion of Patients Who Achieve Fasting TG <500 mg/dL (5.65 mmol/L) Compared to Placebo

    Measured: Month 12

  4. 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

    Measured: Month 12

  5. Adjudicated Acute Pancreatitis Event Rate During the Treatment Period Compared to Placebo

    Measured: Week 1 through Week 53

  6. Absolute Change in Hepatic Fat Fraction (HFF) Between Olezarsen Treatment Group and Pooled Placebo

    Measured: Baseline through Month 12

Timeline

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

  1. First posted15 Oct 2021
  2. Study start25 Oct 2021
  3. Primary completion22 Oct 2024
  4. Study completion8 Jul 2025

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079919
Sponsor's protocol ID
ISIS 678354-CS5
Other IDs
2021-002192-19, 2024-510696-38-00
Status last verified
Feb 2026
First submitted
4 Oct 2021
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
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

Publications

  • Marston NA, Bergmark BA, Alexander VJ, Prohaska TA, Kang YM, Moura FA, Zimerman A, Waldman E, Weinland J, Murphy SA, Goodrich EL, Zhang S, Xia S, Li D, Goldberg AC, Goudev A, Badimon L, Kiss RG, Vrablik M, Gaudet D, Moulin P, Stroes ESG, Banach M, Cohen H, Blom D, Charng MJ, Nordestgaard BG, Nicholls SJ, Tsimikas S, Giugliano RP, Sabatine MS; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for Managing Severe Hypertriglyceridemia and Pancreatitis Risk. N Engl J Med. 2026 Jan 29;394(5):429-441. doi: 10.1056/NEJMoa2512761. Epub 2025 Nov 8.

    PubMed 41211918

  • 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.

    PubMed 40064331

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 209 sites in 23 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, Bulgaria, United Kingdom, Hungary, Spain and 18 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent Change from Baseline in Fasting TG Compared to Placebo (time frame: Baseline and Month 6). 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 NCT05079919, which also lists 2 linked publications.

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 10 Feb 2026.

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