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AzTrials

Severe HypertriglyceridemiaPhase 3NCT05552326

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

A Phase 3 study testing Olezarsen in people with Severe Hypertriglyceridemia, run by Ionis Pharmaceuticals, Inc. at 205 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 this 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
446 participants
Where
205 sitesin 23 countries
Study dates
31 Aug 2022to 12 Sep 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
  • 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.
  • Participants must be willing to comply with diet and lifestyle recommendations as able.

Who cannot join

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

Trial locations and contacts

205 sites in 23 countries.

205 sites in 23 countries

United States63 sites

  • Emory University

    Atlanta, Georgia, 30322

  • University of Maryland School of Medicine

    Baltimore, Maryland, 21201

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • Central Research Associates, Inc.

    Birmingham, Alabama, 35205

  • Alabama Clinical Therapeutics, LLC Alabaster

    Birmingham, Alabama, 35235

  • Grace Research, LLC

    Bossier City, Louisiana, 71111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • St. Vincent Medical Group

    Carmel, Indiana, 46290

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • The Ohio State University (OSU)

    Columbus, Ohio, 43203

  • Accel Research Sites

    DeLand, Florida, 32720

  • Accel Clinical Research

    Eatonton, Georgia, 31024

  • Onyx Clinical Research

    Flint, Michigan, 48532

  • Texas Health Family Care

    Fort Worth, Texas, 76107

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Vilo Research Group

    Houston, Texas, 77017

  • Juno Research

    Houston, Texas, 77040

  • Juno Research

    Houston, Texas, 77054

  • Clinical Trial Network

    Houston, Texas, 77074

  • Pioneer Research Solutions, Inc

    Houston, Texas, 77099

  • The Jackson Clinic

    Jackson, Tennessee, 38305

  • University of Florida Jacksonville

    Jacksonville, Florida, 32209

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • Clinical Investigation Specialists Inc.

    Kenosha, Wisconsin, 53144

  • Sante Clinical Research, LLC

    Kerrville, Texas, 78028

  • FMC Science

    Lampasas, Texas, 76550

  • Clinical Trials of America, LLC

    Lenoir, North Carolina, 28645

  • The Research Group of Lexington, LLC

    Lexington, Kentucky, 40503

  • Main Street Physicians Care Waterway

    Little River, South Carolina, 29566

  • NRC Research Institute

    Los Angeles, California, 90015

  • University of Louisville

    Louisville, Kentucky, 40202

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

    Louisville, Kentucky, 40213

  • Meridien Research

    Maitland, Florida, 32751

  • SV Research LLC

    Marion, Ohio, 43302

  • 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

    Miami, Florida, 33125

  • NYU Langone Hospital - Long Island

    Mineola, New York, 11501

  • Clinical Trials of America LA, LLC

    Monroe, Louisiana, 71201

  • Diabetes and Endocrinology Consultants, P.C.

    Morehead City, North Carolina, 28557

  • Randomize Now

    Newnan, Georgia, 30265

  • Harmony Clinical Research, Inc

    North Miami Beach, Florida, 33162

  • Permian Research Foundation

    Odessa, Texas, 79761

  • Orchard Park Family Practice

    Orchard Park, New York, 14127

  • Aspen Clinical Research

    Orem, Utah, 84058

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • Onyx Clinical Research

    Peoria, Arizona, 85381

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Onyx Clinical Research

    Rochester Hills, Michigan, 48307

  • Ogden Clinic Grandview

    Roy, Utah, 84401

  • OnSite Clinical Solutions, LLC

    Salisbury, North Carolina, 28144

  • Diabetes & Glandular Disease Clinic, P.A.

    San Antonio, Texas, 78229

  • Stern Cardiovascular

    Southaven, Mississippi, 38671

  • 3Sync Research

    Sunrise, Florida, 33325

  • R & B Medical Center LLC

    Tampa, Florida, 33614

  • JSV Clinical Research Study, Inc.

    Tampa, Florida, 33634

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74133

  • Tranquil Research

    Webster, Texas, 77598

  • Metabolic Research Institute

    West Palm Beach, Florida, 33401

Other trials in United States

Bulgaria16 sites

  • Medical Center Diamedical EOOD

    Dimitrovgrad, 6400

  • MHAT Haskovo AD

    Haskovo, 6304

  • MHAT Pazardzhik AD

    Pazardzhik, 4400

  • UMHAT - Kaspela EOOD

    Plovdiv, 4000

  • University Multiprofile Hospital for Active Treatment Pulmed OOD

    Plovdiv, 4000

  • UMHAT Kanev AD

    Rousse, 7002

  • MHAT Sliven to MMA Sofia

    Sliven, 8800

  • Medical Center Smolyan Clinical Research OOD

    Smolyan, 4700

  • Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

    Sofia, 1000

  • Acibadem City Clinic Tokuda University Hospital

    Sofia, 1407

  • Medico Dental Center ISUL Tsaritsa Yoanna EOOD

    Sofia, 1527

  • Medical Centre Synexus Sofia EOOD

    Sofia, 1784

  • Medical Center Zara - Med

    Stara Zagora, 6000

  • DCC Equita

    Varna, 9000

  • Specialized Hospital for Active Treatment of Cardiology

    Varna, 9000

  • Medical Centre "Nevromedics" EOOD

    Veliko Tarnovo, 5006

Other trials in Bulgaria

Poland11 sites

  • UCK, I Klinika Kardiologii

    Gdansk, 80-214

  • Biokinetica

    Józefów, 05-410

  • Centrum Medyczne Pratia

    Katowice, 40-081

  • Centra Medyczne Medyceusz

    Lodz, 91-053

  • Clinical Best Solutions

    Lublin, 20-078

  • Etg Lublin

    Lublin, 20-412

  • Centrum Zdrowia Metabolicznego

    Poznan, 60-589

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

    Warsaw, 00-710

  • Centrum Medycnze AMED

    Warsaw, 03-291

  • Narodowy Instytut Kardiologii im. S. Wyszyńskiego - PIB

    Warsaw, 04-628

  • ETG Zamosc / Pro Life Medica Sp. z o.o.

    Zamość, 22-400

Other trials in Poland

Spain11 sites

  • Hospital Germans Trias i Pujol

    Badalona, 8916

  • Hospital Vall d'Hebron

    Barcelona, 8035

  • Hospital Comarcal Infanta Elena

    Huelva, 21007

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Regional de Malaga

    Málaga, 29009

  • Unidad de Ensayos Clinicos

    Málaga, 29010

  • Hospital Provincial de Conxo

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

India10 sites

  • Sri Jayadeva Institute of Cardiovascular Sciences and Research

    Bengaluru, 560069

  • Sir Ganga Ram Hospital

    Delhi, 110060

  • Eternal Hospital

    Jaipur, 302017

  • B. M. Birla Heart Research Centre A Unit of the Calcutta Medical Research Institute

    Kolkata, West Bengal, 700027

  • IPGMER

    Kolkata, 700020

  • Vinaya Hospital and Research Centre (A Unit of Karnataka Institute of Medical Sciences)

    Mangaluru, 575003

  • KEM Hospital

    Mumbai, 4000012

  • Bhatia Hospital

    Mumbai, 400007

  • Manipal Hospital Mysore

    Mysore, 570015

  • Max Super Specialty Hospital

    New Delhi, National Capital Territory of Delhi, 110017

Other trials in India

Brazil9 sites

  • NUPEC - Nucleo de Pesquisa Clinica

    Belo Horizonte, 30220-140

  • Núcleo de Pesquisa Clínica

    Curitiba, 80730-150

  • Hospital Universitario Walter Cantidio - UFC

    Fortaleza, 60430-270

  • Nucleo de Pesquisa em Cirurgia Vascular

    Porto Alegre, 90035-903

  • IBPClin Pesquisa Clinica

    Rio de Janeiro, 20241-180

  • CPQuali Pesquisa Clinica

    São Paulo, 01228-000

  • Instituto do Coração - HCFMUSP

    São Paulo, 05403-000

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

    São Paulo, 05403-900

  • i9 Pesquisas Clínicas/Loema - Instituto de Pesquisas Clínica & Consultores

    São Paulo, 13092-133

Other trials in Brazil

Argentina8 sites

  • CIPREC - Centro de Investigación y Prevención Cardiovascular

    Buenos Aires, C1061AAG

  • Fundacion Favaloro

    Buenos Aires, C1093AAS

  • Centro Médico Dra. Laura Maffei

    Buenos Aires, C1425AGC

  • Glenny Corp SA

    Buenos Aires, C1430

  • Instituto Médico DAMIC

    Córdoba, X5003DCE

  • Instituto de Cardiología Corrientes

    Corrientes, W3400CDS

  • Centro Medico San Luis

    San Luis, D5700

  • Clínica FUSAVIM Privada

    Villa María, X5900JKA

Other trials in Argentina

Netherlands7 sites

  • Vumc Amsterdam Medical Center

    Amsterdam, 1081BT

  • Gelre Ziekenhuizen Apeldoorn

    Apeldoorn, 7334 DZ

  • Reinier de Graaf Ziekenhuis

    Delft, 2625 AD

  • Het Van Weel Bethesda ziekenhuis

    Dirksland, 3247BW

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT

  • Bethesda Diabetes Research Center

    Hoogeveen, 7909 AA

  • Canisius-Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532 SZ

Other trials in Netherlands

Romania7 sites

  • Cabinet Medical Individual SC DIANA BARBONTA SRL

    Alba, 510053

  • Cardioplus Center SRL

    Baia Mare, 430123

  • Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed S.R.L

    Brasov, 500283

  • Centrul Medical Medicover Victoria

    Bucharest, 10626

  • S.C. SAL MED S.R.L., Cardiologie

    Piteşti, 10437

  • Cardio Med SRL

    Târgu Mureş, 540124

  • S.C. Mediab Srl

    Târgu Mureş, 540142

Other trials in Romania

Canada6 sites

  • Aggarwal and Associates Ltd.

    Brampton, Ontario, L6T 0G1

  • Joanne F. Liutkus Medicine Professional Corporation

    Cambridge, Ontario, N3H 4L5

  • Unite de Recherche Clinique

    Saint-Jérôme, Quebec, J7Z 2V4

  • Bluewater Clinical Research Group

    Sarnia, Ontario, N7t 4X3

  • NL Health Services

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Toronto General Hospital

    Toronto, Ontario, M5G2C4

Other trials in Canada

Czechia6 sites

  • CTC Hodonin s.r.o.

    Hodonín, 695 01

  • KardioBusak s.r.o.

    Louny, 440 01

  • Fakultni nemocnice v Motole

    Prague, 150 06

  • Endokrinologie Cerny Most s.r.o.

    Prague, 198 00

  • Diabetologická a endokrinologická ambulance Milan Kvapil

    Příbram, 267 01

  • AeskuLab k.s

    Teplice, 415 01

Other trials in Czechia

Hungary6 sites

  • Lausmed Kft.

    Baja, H-6500

  • DRC Gyogyszervizsgalo Kozpont Kft

    Balatonfüred, H-8230

  • Obudai Egeszsegugyi Centrum

    Budapest, H-1036

  • Clinexpert Kft.

    Budapest, H1033

  • Pharma4 Trial Kft.

    Gyöngyös, H-3200

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz Diabetologiai szakrendeles

    Kaposvár, H-7400

Other trials in Hungary

Slovakia6 sites

  • Alian s.r.o.

    Bardejov, 08501

  • Ambulancia diabetologicka a poruch latkovej premeny a vyzivy

    Bratislava, 83106

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

    Lučenec, 98401

  • Diab sro

    Rožňava, 04801

  • Interna SK, s.r.o.

    Svidník, 08901

  • Areteus s.r.o

    Trebišov, 07501

Other trials in Slovakia

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

    Kaohsiung City, 80756

  • Mackay Memorial Hospital

    New Taipei City, 251404

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704017

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111045

  • Chang Gung Medical Foundation - Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

Greece5 sites

  • University General Hospital of Alexandroupoli

    Alexandroupoli, 68100

  • AHEPA Building of Evaggelismos

    Athens, 10676

  • University General Hospital ATTIKON

    Athens, 12462

  • Hygeia Hospital

    Athens, 15123

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 54636

Other trials in Greece

Lithuania5 sites

  • Saules seimons medicinos centras

    Kaunas, 49449

  • Klinikiniai sprendimai

    Kaunas, LT-49387

  • Clinic of Cardiology and Rehabilitation

    Klaipėda, LT-91131

  • Republican Panevezys Hospital

    Panevezys, LT-35144

  • Pirmoji viltis

    Šiauliai, LT-76206

Other trials in Lithuania

Mexico5 sites

  • Centro de Investigación Cardiométabolica de Aguascalientes S.A. de C.V.

    Aguascalientes, 20230

  • Cientia Investigacion Clinica Sc

    Chihuahua City, 32103

  • Medical Care and Research S.A de C.V.

    Mérida, Yucatán, 97070

  • Clinstile, S.A. de C.V.

    Mexico City, 06700

  • Clinical Research Institute S.C.

    Tlanepantla, 54055

Other trials in Mexico

Belgium4 sites

  • AZ Sint-Jan Brugge

    Bruges, 8000

  • Hôpital Erasme

    Brussels, 1070

  • Virga Jessa Hospital

    Hasselt, 3500

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Italy4 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

  • AORN S. Anna e S. Sebastiano UOC FARMACIA

    Caserta, 81100

  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna

    Cona, 44124

  • Fondazione I.R.C.C.S. Policlinico "San Matteo" c/o C.U.R.M.

    Pavia, 27100

Other trials in Italy

Malaysia4 sites

  • Sultanah Bahiyah Hospital

    Alor Star, Kedah, 05460

  • Pulau Pinang Hospital

    George Town, Pulau Pinang, 10450

  • University Malaya Medical Centre (UMMC)

    Kuala Lumpur, 59100

  • Hospital Taiping

    Taiping, Perak, 34000

Other trials in Malaysia

France3 sites

  • Hopital de Hautepierre

    Strasbourg, 67098

  • ELSAN - Polyclinique Vauban

    Valenciennes, 59300

  • GHM les Portes du Sud

    Vénissieux, 69200

Other trials in France

Portugal2 sites

  • Hospital CUF Tejo

    Lisbon, 1350-352

  • Centro Hospitalar de Entre Douro e Vouga

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Sweden1 site

  • Acardo MedSite

    Solna, SE-171 64

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Olezarsen, Placebo
Keywords
Hypertriglyceridemia, Hyperlipidemias, Metabolic Diseases
Medical subject headings
Hypertriglyceridemia, Hyperlipidemias, Metabolic Diseases

What participants receive

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

  • OlezarsenDrug

    Also called ISIS 678354, AKCEA-APOCIII-LRx

    Olezarsen will be administered by SC injection.

  • PlaceboDrug

    Olezarsen-matching placebo will be administered by SC injection.

Study groups in NCT05552326
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 subcutaneous (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 posted23 Sep 2022
  2. Study start31 Aug 2022
  3. Primary completion17 Dec 2024
  4. Study completion12 Sep 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
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05552326
Sponsor's protocol ID
ISIS 678354-CS6
Other IDs
2022-501420-20
Status last verified
Oct 2025
First submitted
20 Sep 2022
Last updated
22 Oct 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

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 205 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 3 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 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 205 sites in United States, Bulgaria, Poland, Spain, India 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 NCT05552326, 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 22 Oct 2025.

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