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HypertriglyceridemiaPhase 3NCT05610280

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

A Phase 3 study testing Olezarsen in people with Hypertriglyceridemia and Cardiovascular Diseases, run by Ionis Pharmaceuticals, Inc. at 168 sites in 14 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 effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo in participants with hypertriglyceridemia and atherosclerotic cardiovascular disease, or with severe hypertriglyceridemia. Read more about this study

Who is it for?
Ages 18 years and older
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
1,478 participants
Where
168 sitesin 14 countries
Study dates
21 Nov 2022to 9 Jun 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

  • Participants must fall into 1 of the following groups (a or b):
  • Hypertriglyceridemia with fasting TG ≥200 mg/dL (2.26 millimoles per liter [mmol/L]) and <500 mg/dL (5.65 mmol/L) with either
  • Clinical diagnosis of atherosclerotic cardiovascular disease (ASCVD) or
  • At increased risk for ASCVD
  • Severe hypertriglyceridemia with fasting TG ≥500 mg/dL (5.65 mmol/L)
  • Participants should be on standard of care (SOC) lipid-lowering medications per local guidelines. Lipid-lowering medications should be optimized and stabilized for at least 4 weeks prior to Screening to minimize changes in these medications during the study.

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 upper limit of normal unless due to Gilbert's syndrome
  • Estimated GFR < 30 mL/min/1.73 m^2
  • NOTE: Other Inclusion/Exclusion criteria may apply.

Trial locations and contacts

168 sites in 14 countries.

168 sites in 14 countries

United States68 sites

  • Maryland Cardiovascular Specialists

    Baltimore, Maryland, 21229

  • Cardiovascular Research Foundation of Southern California

    Beverly Hills, California, 90210

  • Westside Medical Associates of Los Angeles

    Beverly Hills, California, 90211

  • Alabama Clinical Therapeutics, LLC Alabaster

    Birmingham, Alabama, 35235

  • Excel Clinical Medical Trials

    Boca Raton, Florida, 33434

  • Aultman Hospital Cardiology Clinical Trials

    Canton, Ohio, 44710

  • Medical University of South Carolina (MUSC)

    Charleston, North Carolina, 29425

  • Charleston Area Medical Center (CAMC) Clinical Trials Center

    Charleston, West Virginia, 25304

  • Centricity Research

    Columbus, Georgia, 31904

  • McConnell Heart Health Center

    Columbus, Ohio, 43214

  • West Broadway Clinic

    Council Bluffs, Iowa, 51501

  • Central Oklahoma Early Detection Center

    Edmond, Oklahoma, 73034

  • Evanston Premier Healthcare Research LLC

    Evanston, Illinois, 60201

  • Aa Mrc, Llc

    Flint, Michigan, 48504

  • Finlay Medical Research - West Palm

    Greenacres City, Florida, 33467

  • Moses H. Cone Memorial Hospital

    Greensboro, North Carolina, 27401

  • Clinical Investigation Specialists, Inc

    Gurnee, Illinois, 60031

  • Global Research Associates

    Homestead, Florida, 33030

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Juno Research, LLC

    Houston, Texas, 77040

  • Diabetes/Lipid Management & Research Center

    Huntington Beach, California, 92648

  • Heart Center Research PC

    Huntsville, Alabama, 35801

  • The Jackson Clinic

    Jackson, Tennessee, 38301

  • University of Kansas Medical Center (KUMC)

    Kansas City, Kansas, 66160

  • University of California, San Diego (UCSD)

    La Jolla, California, 92037

  • 3Sync Research

    Lake Worth, Florida, 33460

  • Green and Seidner Family Practice Associates

    Lansdale, Pennsylvania, 19446

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 49148

  • Clinical Research of South Nevada

    Las Vegas, Nevada, 89104

  • Palm Research Center, Inc.

    Las Vegas, Nevada, 89148

  • Clinical Trials Research

    Lincoln, California, 95648

  • Main Street Physicians Care Waterway

    Little River, South Carolina, 29566

  • Norton Cardiovascular Associates

    Louisville, Kentucky, 40205

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky, 40213

  • Carient Heart & Vascular

    Manassas, Virginia, 20109

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Texas Institute of Cardiology

    McKinney, Texas, 75071

  • Southern Endocrinology Associates

    Mesquite, Texas, 75149

  • Finlay Medical Research

    Miami, Florida, 33126

  • Advanced Medical Research Institute (AMRI)

    Miami, Florida, 33174

  • De La Cruz Research Center, LL

    Miami, Florida, 33184

  • Cardiovascular Research of Northwest Indiana, LLC

    Munster, Indiana, 46321

  • Affinity Health Corp.

    Nashville, Tennessee, 37203

  • Suncoast Clinical Research, Inc. - New Port Richey

    New Port Richey, Florida, 34652

  • Suncoast Clinical Research, Inc. - Palm Harbor

    New Port Richey, Florida, 34652

  • Amicis Research

    Northridge, California, 91324

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Proactive Clinical Research

    Oakland Park, Florida, 33309

  • Ocala Cardiovascular Research

    Ocala, Florida, 34471

  • Affinity Health

    Park Ridge, Illinois, 60068

  • Comprehensive Medical & Research Center

    Plantation, Florida, 33317

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Monument Health Clinical Research

    Rapid City, South Dakota, 57701

  • Health Concepts

    Rapid City, South Dakota, 57702

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • OnSite Clinical Solutions, LLC

    Rock Hill, South Carolina, 29732

  • FMC Science

    Round Rock, Texas, 78681

  • Northern California Research

    Sacramento, California, 95821

  • St. Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

  • Amicis Research Center

    Santa Clarita, California, 91344

  • Summit Research Group, LLC

    Stow, Ohio, 44224

  • JSV Clinical Research Study, Inc

    Tampa, Florida, 33634

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

    Torrance, California, 90502

  • Atlanta Heart Specialists

    Tucker, Georgia, 30084

  • Tennessee Center for Clinical Trials

    Tullahoma, Tennessee, 37388

  • Amicis Research Center

    Valencia, California, 91355

  • Mercy One Iowa Heart Center

    West Des Moines, Iowa, 50266

Other trials in United States

Netherlands15 sites

  • Academic Medical Center - Department of Vascular Medicine

    Amsterdam, 1105AZ

  • Ziekenhuis Rijnstate

    Arnhem, 6815 AD

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD

  • Deventer Ziekenhuis

    Deventer, 7416 SE

  • Het Van Weel-Bethesda Ziekenhuis

    Dirksland, 3247 BW

  • Groene Hart Ziekenhuis

    Gouda, 2803 HH

  • Spaarne Gasthuis

    Haarlem, 2035 RC

  • Zuyderland Medisch Centrum

    Heerlen, 6419 PC

  • Bethesda Diabetes Research Center

    Hoogeveen, 7909 AA

  • Canisius-Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, 6532 SZ

  • D&A Research

    Sneek, 8601 ZR

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584 CX

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB

  • Albert Schweitzer Ziekenhuis - Location Dordrecht

    Zwijndrecht, 3331 LZ

  • Albert Schweitzer Ziekenhuis

    Zwijndrecht, 3331 LZ

Other trials in Netherlands

Canada13 sites

  • Centricity Research - Barrie Endocrinology

    Barrie, L4N 7L3

  • Centricity Research - Brampton Endocrinology

    Brampton, L6S 6J6

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

  • Centricity Research - Vaughan Endocrinology

    Concord, Ontario, L4K 4M2

  • Centricity Research - Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1

  • Montreal Heart Institute - Institut de Cardiologie de Montreal

    Montreal, Quebec, H1T 1C8

  • Institute de Recherches Cliniques de Montreal

    Montreal, Quebec, H2W 1R7

  • Centricity Research - Oshawa Multispecialty

    Oshawa, Ontario, L1J 2K9

  • Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec, G1V 4W2

  • Centre de Recherche Saint-Louis

    Québec, G1W 4R4

  • Bluewater Clinical Research Group Inc

    Sarnia, Ontario, N7t 4X3

  • Centricity Research - Toronto LMC Multispecialty

    Toronto, Ontario, M4G 3E8

  • ARC Biosystems

    Vancouver, British Columbia, V6Z 2C7

Other trials in Canada

Poland13 sites

  • SALVIA Lekston i Madej s.j.

    Katowice, 40-772

  • Jagiellonskie Centrum Innowacji Sp. z o.o.

    Krakow, 30-348

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

  • FutureMeds

    Lodz, 91-363

  • INSTYTUT CENTRUM ZDROWIA MATKI POLKI - Klinika Kardiologii i Wad Wrodzonych Doroslych

    Lodz, 93-338

  • Praktyka Lekarska Ewa Krzyzagorska

    Poznan, 61-655

  • FutureMeds Warszawa Centrum

    Warsaw, 00-215

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

    Warsaw, 00-710

  • FutureMeds - Centrum Medyczne AMED Warszawa Targowek

    Warsaw, 03-291

  • Narodowy Instytut Kardiologii Stefana kardynala Wyszynskiego - Panstwowy Instytut Badawczy, Klinika Kardiologii i Angiologii Interwencyjnej

    Warsaw, 04-628

  • FutureMeds Sp. z o.o

    Wroclaw, 50-088

  • Slaski Park Technologii Medycznych Kardio-Med Silesia Sp. z o. o

    Zabrze, 48-100

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

    Zamość, 22-400

Other trials in Poland

Bulgaria11 sites

  • MHAT Sv. Ivan Rilski - 2003 OOD

    Dupnitsa, 2600

  • University Multiprofile Hospital for Active Treatment Pulmed OOD

    Plovdiv, 4000

  • SHATC Medica Cor EAD

    Rousse, 7013

  • Medical Center for Specialized Medical Help in Cardiovascular Diseases OOD

    Sofia, 1000

  • MBAL National Cardiology Hospital

    Sofia, 1309

  • University Multiprofile Hospital for Active Treatment Alexandrovska

    Sofia, 1431

  • University Multiprofile Hospital for Active Treatment

    Sofia, 1431

  • Medico Dental Center ISUL Tsaritsa Yoanna EOOD

    Sofia, 1527

  • UMHAT Prof. Dr. Stoyan Kirkovich

    Stara Zagora, 6003

  • Diagnostic Consultative Center Equita (DCC Equita)

    Varna, 9000

  • Specialized Hospital for Active Treatment of Cardiology

    Varna, 9020

Other trials in Bulgaria

Spain10 sites

  • Hospital Abente y Lago

    A Coruña, 15001

  • Hospital Germans Trias i Pujol

    Badalona, 8916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8025

  • Calle Villarroel 170

    Barcelona, 8036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, 30120

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Czechia8 sites

  • UNIVMED s.r.o. - Kardiologicka Ambulance

    Brno, 60300

  • Cevni ambulance - MATMED s.r.o.

    Hodonín, 695 01

  • Edumed s.r.o., Kardiologicka, endokrinologicka, diabetologicka a interni ambulance Nachod

    Jaroměř, 551 01

  • Affidea Praha s.r.o.

    Prague, 148 00

  • Diabetologicka a endokrinologicka ambulance Milan Kvapil s.r.o

    Prague, 149 00

  • Endokrinologie Cerny Most s.r.o.

    Prague, 19800

  • AeskuLab k.s

    Teplice, 415 01

  • MUDr. Nina Zemkova s.r.o. Interni Ambulance

    Uherské Hradiště, 686 68

Other trials in Czechia

Italy7 sites

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola

    Bologna, 40138

  • ASST NORD MILANO-Ospedale Edoardo Bassini

    Cinisello Balsamo, 20092

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

    Cona, 44124

  • Centro Cardiologico Monzino

    Milan, 20138

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

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

    Rome, 168

Other trials in Italy

Denmark6 sites

  • Aarhus University Hospital

    Aarhus, 8000

  • Sydvestjysk Hospital

    Esbjerg, 6700

  • Gentofte Hospital

    Hellerup, 2900

  • Godstrup Regional Hospital (Gødstrup)

    Herning, 7400

  • OUH Svendborg Hospital

    Svendborg, 5700

  • Viborg Regional Hospital

    Viborg, 8800

Other trials in Denmark

France5 sites

  • HCL Hopital Louis Pradel

    Bron, 69677

  • CHU Dijon Bourgogne - Hopital Francois Mitterrand

    Dijon, 21000

  • AP-HP Hopital Pitie-Salpetriere

    Paris, 75013

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

    Valenciennes, 59300

  • GHM les Portes du Sud

    Vénissieux, 69200

Other trials in France

Portugal4 sites

  • Centro Hospitalar de Lisboa Ocidental. E.P.E, - Hospital Santa Cruz

    Carnaxide, 2790-134

  • Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Egas Moniz

    Lisbon, 1349-019

  • Centro Hospitalar Universitario de Lisboa Norte - Hospital de Santa Maria

    Lisbon, 1649-036

  • Centro Hospitalar de Vila Nova de Gaia/Espinho EPE

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Slovakia4 sites

  • Alian, s.r.o., Kardiologicka ambulancia

    Bardejov, 085 01

  • Cardio D&R, S.R.O. Kosice

    Košice, 040 22

  • Diab sro

    Rožňava, 048 01

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

    Svidník, 8901

Other trials in Slovakia

Hungary3 sites

  • Clinexpert Kft.

    Budapest, 1033

  • Obudai Egeszsegugyi Centrum

    Budapest, H-1036

  • CRU Hungary Kft.

    Encs, H-3860

Other trials in Hungary

Norway1 site

  • The Lipid Clinic (Oslo University Hospital)

    Oslo, 424

Other trials in Norway

About this study

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

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

Read the detailed description

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

The Screening Period was extended with no impact to overall study timelines.

A coronary computed tomographic angiography (CTA) sub study will be performed to assess whether triglyceride lowering through inhibition of apoC-III protein synthesis may reduce coronary plaque progression.

Being tested
Olezarsen, Placebo
Keywords
ISIS 678354, Olezarsen
Medical subject headings
Hypertriglyceridemia, Cardiovascular Diseases, Atherosclerosis

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 NCT05610280
Study groupRoleWhat they receive
OlezarsenExperimentalParticipants will be randomized to receive multiple doses of olezarsen, once every 4 weeks by subcutaneous (SC) injection up to Week 49.
Receives: Drug: Olezarsen
PlaceboPlacebo comparatorParticipants will be randomized to receive olezarsen-matching placebo, once every 4 weeks by SC injection up to 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 to Week 25 in Fasting Triglycerides (TG) Compared to Placebo

    Measured: Baseline to Week 25

Secondary outcomes (9)

  1. Percent Change From Baseline to Week 53 in Fasting TG Compared to Placebo

    Measured: Baseline to Week 53

  2. Proportion of Participants who Achieve Fasting TG <150 Milligrams per Deciliter (mg/dL) at Weeks 25 and 53 Compared to Placebo

    Measured: Baseline, Weeks 25 and 53

  3. Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein C-III (apoC-III) Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

  4. Percent Change From Baseline to Weeks 25 and 53 in Fasting Very Low-Density Lipoprotein-Cholesterol (VLDL)-C Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

  5. Percent Change From Baseline to Weeks 25 and 53 in Fasting Remnant Cholesterol Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

  6. Percent Change From Baseline to Weeks 25 and 53 in Fasting non-High Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

  7. Percent Change From Baseline to Weeks 25 and 53 in Fasting High-Density Lipoprotein-Cholesterol (HDL)-C Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

  8. Percent Change From Baseline to Weeks 25 and 53 in Fasting Apolipoprotein B (apoB) Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

  9. Percent Change From Baseline to Weeks 25 and 53 in Fasting Low-Density Lipoprotein-Cholesterol (LDL)-C Compared to Placebo

    Measured: Baseline to Weeks 25 and 53

Timeline

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

  1. First posted9 Nov 2022
  2. Study start21 Nov 2022
  3. Primary completion8 Aug 2024
  4. Study completion9 Jun 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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,478 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610280
Sponsor's protocol ID
ISIS 678354-CS9
Other IDs
2022-501486-53
Status last verified
Feb 2026
First submitted
2 Nov 2022
Last updated
10 Feb 2026
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, Prohaska TA, Moura FA, Zimerman A, Alexander VJ, Kang YM, Weinland J, Ran X, Murphy SA, Zhang S, Li D, Banach M, Stroes ESG, Kiss R, Gaudet D, Vrablik M, Goudev A, Bax JJ, Budoff MJ, Foldyna B, Lu MT, Tsimikas S, Giugliano RP, Sabatine MS. Effect of APOC3 Inhibition With Olezarsen on Coronary Atherosclerosis: Essence-TIMI 73b Imaging Study. Circulation. 2026 May 19;153(20):1539-1548. doi: 10.1161/CIRCULATIONAHA.126.080012. Epub 2026 Mar 30.

    PubMed 41910513

  • Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Kang YM, Weinland J, Murphy SA, Goodrich EL, Zhang S, Li D, Banach M, Stroes E, Lu MT, Tsimikas S, Giugliano RP, Sabatine MS; Essence-TIMI 73b Investigators. Targeting APOC3 with Olezarsen in Moderate Hypertriglyceridemia. N Engl J Med. 2025 Oct 2;393(13):1279-1291. doi: 10.1056/NEJMoa2507227. Epub 2025 Aug 30.

    PubMed 40888739

  • Bergmark BA, Marston NA, Prohaska TA, Alexander VJ, Zimerman A, Moura FA, Kang YM, Murphy SA, Zhang S, Lu MT, Karwatowska-Prokopczuk E, Tsimikas S, Giugliano RP, Sabatine MS. Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence-TIMI 73b trial. Am Heart J. 2025 Aug;286:116-124. doi: 10.1016/j.ahj.2025.02.022. Epub 2025 Mar 11.

    PubMed 40081744

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Olezarsen in people with Hypertriglyceridemia and Cardiovascular Diseases, run by Ionis Pharmaceuticals, Inc. at 168 sites in 14 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 6 inclusion and 5 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 168 sites in United States, Netherlands, Canada, Poland, Bulgaria and 9 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 to Week 25 in Fasting Triglycerides (TG) Compared to Placebo (time frame: Baseline to Week 25). 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 NCT05610280, which also lists 3 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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