Advancing Hypertriglyceridemia Treatment - Olezarsen Clinical Trials

Stay Informed Download the Genetic Testing for FCS flyer and CORE Clinical Trials Fact Sheet

hypertriglyceridemia clinical trial hypertriglyceridemia clinical trial

Ionis is committed to developing better treatment options for people suffering from severe hypertriglyceridemia (sHTG). We are currently conducting late-stage clinical trials of olezarsen, an investigational medication designed to reduce excessive triglyceride (TG) levels in the blood.

What are the CORE trials?

Phase III, multicenter, double-blind, placebo-controlled studies evaluating the efficacy and safety of olezarsen administered subcutaneously for patients with sHTG (triglyceride [TG] levels ≥500 mg/dL).

To learn more about enrolling in a CORE clinical trial, contact our clinical trial information center [email protected] or call (844) 691-2147.


In addition, Ionis is conducting the Essence trial. This trial will evaluate the safety and efficacy of olezarsen for patients with triglyceride levels ≥ 150mg/dL. 35 This trial is designed to provide supplementary data on the safety and efficacy of olezarsen in a broader patient population

What is olezarsen?

Olezarsen is an investigational ligand-conjugated antisense (LICA) medicine consisting of:

  • an antisense oligonucleotide directed against the mRNA for apoC-Ill.
  • a liver-specific ligand designed to increase the binding and uptake of olezarsen by hepatocytes, where most apoC- Ill is produced.

Olezarsen is designed to reduce production of apoC-Ill in the liver and enhance the uptake of triglyceride (TG)-rich particles in peripheral tissues.

What is an antisense medicine?
Antisense therapies, also known as antisense oligonucleotides, or ASOs, are designed to bind precisely with RNA, halting the process of creating a disease-causing protein.

What is LICA technology?
LICA is a chemical technology developed by lonis that involves the attachment of a molecule called a ligand that binds with receptors on the surfaces of cells in a highly specific manner.
Contact Ionis to learn more about the CORE clinical trials    ↓

Why should patients participate in this research?

Early-stage clinical studies support once monthly administration of olezarsen with a well-tolerated safety profile. Olezarsen is an investigational drug and further studies are needed to evaluate the safety and efficacy of olezarsen.




What patients will qualify?

Patients may be eligible to participate in CORE if they:

  • Are over 18 years old
  • Are on lipid-lowering therapy that should adhere to standard-of-care per local guidelines
  • Have fasting TG levels > 500 mg/dL despite ongoing use of standard-of-care lipid-lowering medications

Patients with elevated hemoglobin A1c (HbA1c) levels ≥ 9.5% and/or estimated glomerular filtration rates (eGFRs) of <30 mL/min/1.73 m^2 at screening are not eligible and other inclusion and exclusion criteria will be evaluated before enrollment.

To learn more about enrolling in a CORE clinical trial, contact our clinical trial information center [email protected] or call (844) 691-2147.


Associated Risks of Unmanaged Elevated Triglycerides

Baylor College of Medicine cardiologist Dr. Christie Ballantyne explains the associated health risks of unmanaged elevated triglycerides.

What is the importance of studying apolipoprotein C3 (apoC-Ill) and what could that mean for patients living with severe hypertriglyceridemia (sHTG)?
Duration: 1 minute 22 seconds
Why are the CORE trials important for patients living with severe hypertriglyceridemia (sHTG)?
Duration: 1 minute 21 seconds

Associated Health Risks for People Living with Severe Hypertriglyceridemia (sHTG)

Endocrinologist Dr. Robert Eckel, Professor of Medicine Emeritus at the University of Colorado School of Medicine, explains the associated health risks for people living with severe hypertriqlyceridemia (SHTG).

What is the importance of researching apolipoprotein C3 (apoC-Il) inhibition for severe hypertriqlyceri-demia (sHTGI?
Duration: 54 seconds

CORE Study

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    Velocity Clinical Research

    Chula Vista, California
    91911, United States

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    Diabetes/Lipid Management & Research Center

    Huntington Beach, California
    92648, United States

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    America Clinical Trials

    Tarzana, California
    91356, United States

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    Excel Medical Clinical Trials, LLC

    Boca Raton,, Florida
    United States, 33434

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    Alabama Clinical Therapeutics, LLC Alabaster

    Birmingham, Alabama
    35235, United States

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    Finlay Medical Research

    Miami, Florida
    33126, United States

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    Ocala Cardiovascular Research

    Ocala, Florida
    34471, United States

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    Bayside Clinical Research

    Trinity, Florida
    34655, United States

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    IACT Health

    Columbus, Georgia
    31904, United States

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    Affinity Health

    Oak Brook, Illinois
    60523, United States

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    West Broadway Clinic

    Council Bluffs, Iowa
    51501, United States

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    Kansas University Medical Center

    Kansas City, Kansas
    66160, United States

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    Continental Clinical Solutions

    Towson, Maryland
    21204, United States

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

    Ann Arbor, Michigan
    48109, United States

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    Aa Mrc, Llc

    Flint, Michigan
    48504, United States

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    Washington University School of Medicine

    Saint Louis, Missouri
    63110, United States

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    Northwell Health

    Great Neck, New York
    11021, United States

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    NYU Langone

    New York, New York
    10016, United States

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    Novant Health Cancer Institute Elizabeth Investigational Drug Services

    Charlotte, North Carolina
    28204, United States

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    Cone Medical Center

    Greensboro, North Carolina
    27401, United States

  • location icon

    Aventiv Research

    Columbus, Ohio
    43213, United States

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    Summit Research Group, LLC

    Munroe Falls, Ohio
    44262, United States

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    Hightower Clinical Trial Services

    Oklahoma City, Oklahoma
    73102, United States

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    Velocity Clinical Research

    Medford, Oregon
    97504, United States

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    Health Concepts

    Rapid City, South Dakota
    57702, United States

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    Velocity Clinical Research

    Cedar Park, Texas
    78613, United States

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    University of Texas Southwestern

    Dallas, Texas
    75390, United States

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    Baylor College of Medicine

    Houston, Texas
    77030, United States

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    Velocity Clinical

    West Jordan, Utah
    84088, United States

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    Manassas Clinical Research Center

    Manassas, Virginia
    20110, United States

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    York Clinical Research LLC

    Norfolk, Virginia
    23510, United States

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    West Virginia University Heart and Vascular Institute

    Morgantown, West Virginia
    26506, United States

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    Royal Prince Alfred Hospital

    Camperdown, New South Wales
    2050, Australia

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    Royal North Shoe Hospital

    Saint Leonards, New South Wales
    2065, Australia

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    Dr. Heart Pty Ltd at Cholesterol Care Australia

    Woolloongabba, Queensland
    4102, Australia

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    Monash Medical Centre

    Clayton S, Victoria
    3168, Australia

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    Medical Center Doctor Staykov EOOD

    8008, Bulgaria

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    Medical Center Diamedical 2013 OOD

    6400, Bulgaria

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    MHAT “Dr. Tota Venkova” AD

    5300, Bulgaria

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    Medical Center “Hera” EOOD

    3400, Bulgaria

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    Medical Center Smolyan Clinical Research OOD

    4700, Bulgaria

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    Medical Center Endomedical EOOD

    1606, Bulgaria

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

    Stara Zagora
    6000, Bulgaria

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    Medical Centre Nevromedics EOOD

    Veliko Tarnovo
    5006, Bulgaria

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    Arc Biosystems

    Vancouver, British Columbia
    V6Z2C7, Canada

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    Canadian Phase Onward Inc

    Toronto, Ontario
    M3J 0K2, Canada

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    Chicoutimi, Quebec
    G7H 7K9, Canada

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    Institut de recherches cliniques de Montréal (IRCM)

    Montréal, Quebec
    H2W 1R7, Canada

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    Clinique des Maladies Lipidiques de Quebec Inc.

    Québec, Quebec
    G1V 4W2, Canada

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    Brandýs Nad Labem
    250 01, Czechia

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    EDUMED s.r.o.

    547 01, Czechia

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    Interni Ambulance

    Uherské Hradiště
    686 01, Czechia

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    Aalborg University Hospital

    9000, Denmark

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    Esbjerg Hospital

    6700, Denmark

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    Bispebjerg Hospital

    2000, Denmark

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    Herlev Hospital

    2730, Denmark

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    Hôpital Louis Pradel

    69677, France

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    CHU Dijon Bourgogne

    21079, France

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    Hopital de la Conception

    13005, France

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    CHU Nantes – Hopital Nord Laennec

    44093, France

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    BKS Research Kft

    Hatvan, Heves
    3000, Hungary

  • location icon

    Medifarma 98 Kft

    Nyíregyháza, Szabolcs-Szatmar-Bereg
    4400, Hungary

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    CRU Hungary Kft

    3860, Hungary

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    Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet

    4032, Hungary

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    Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    8000, Hungary

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    DRC Gyogyszervizsgalo Kozpont Kft

    8230, Hungary

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    Rabin Medical Center

    Petach Tikva
    4941492, Israel

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    Ospdale E. Bassini

    20092, Italy

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    A.O. Policlinico Universitario P. Giaccone

    90127, Italy

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    Policlinico Umberto

    00161, Italy

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    Academic Medical Center – Department of Vascular Medicine

    Amsterdam, AZ
    1105 , Netherlands

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    Rijnstate Arnhem

    Arnhem, AD
    6815 , Netherlands

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    Albert Schweitzer ziekenhuis

    Dordrecht, AT
    3318 , Netherlands

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    Ziekenhuis Gelderse Vallei

    Ede, RP
    6716 , Netherlands

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    Auckland City Hospital

    Grafton, Auckland
    1010, New Zealand

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    New Zealand Clinical Research

    8011, New Zealand

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    Lipid Clinic

    0586, Norway

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    40-772, Poland

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    Praktyka Lekarska Ewa Krzyzagorska

    61-655, Poland

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    ClinMedica Research Sp.z o.o.

    96-100, Poland

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    Futuremeds sp. z o.o

    50-088, Poland

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    Instytut Centrum Zdrowia Matki Polki Klinika

    93-338, Poland

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    Hospital Egas Moniz – Centro Hospitalar de Lisboa Ocidental

    1349-019, Portugal

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    Nemocnica s poliklinikou Brezno

    97701, Slovakia

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    Iatros International

    Bloemfontein, Free State
    9301, South Africa

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    Unitas Hospital

    Centurion, Gauteng
    157, South Africa

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    Dr Jan Engelbrecht and Ass. Inc

    Cape Town, Western Cape
    7130, South Africa

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    TREAD Research – Department of Cardiology

    Parow, Western Cape
    7500, South Africa

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    University of Cape town – Lipid Factory

    Cape Town
    7925, South Africa

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    Hospital Abente y Lago

    A Coruña
    15001, Spain

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    Hospital de la Santa Creu i de Sant Pau

    08041, Spain

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    Hospital Clinic Barcelona

    8063, Spain

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

    8208, Spain

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    Hospital Universitari de Bellvitge

    8907, Spain

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    Hospital Universitario Reina Sofia

    14004, Spain

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    Hospital Universitario

    28041, Spain

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

    41013, Spain

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    Sahlgrenska, University Hospital

    Goteborg, Västra Götalands Län
    413 45, Sweden

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    Karolinska University Hospital Huddinge

    14186, Sweden

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    Huddersfield Royal Infirmary

    Lindley, Huddersfield
    HD3 3EA, United Kingdom

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    Hull Royal Infirmary

    HU3 2JZ, United Kingdom

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    Finlay Medical Research

    Greenacres City, Florida
    33467, United States

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    Columbus Clinical Services

    Miami, Florida
    33125, United States

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    Harmony Clinical Research, Inc

    North Miami Beach, Florida
    33162, United States

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    Combined Research Orlando Phase I-IV

    Orlando, Florida
    32807, United States

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    3Sync Research

    Sunrise, Florida
    United States, 33325

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    R & B Medical Center LLC

    Tampa, Florida
    33614, United States

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    The Research Group of Lexington, LLC

    Lexington, Kentucky
    40503, United States

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    Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky
    40213, United States

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    Grace Research, LLC

    Bossier City, Louisiana
    71111, United States

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    Clinical Trials of America LA, LLC

    Monroe, Louisiana
    71201, United States

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    Clinical Trials of America, LLC

    Lenoir, North Carolina
    28645, United States

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    SV Research LLC

    Marion, Ohio
    43302, United States

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    Main Street Physicians Care Waterway

    Little River, South Carolina
    29566, United States

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    Juno Research

    Houston, Texas
    77040, United States

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    Juno Research

    Houston, Texas
    77054, United States

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    Pioneer Research Solutions, Inc

    Houston, Texas
    77099, United States

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    FMC Science

    Lampasas, Texas
    76550, United States

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    Texas Institute of Cardiology

    McKinney, Texas
    75071, United States

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    Southern Endocrinology Associates

    Mesquite, Texas
    75149, United States

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    Permian Research Foundation

    Odessa, Texas
    79761, United States


  • What are key challenges in clinical management of severe HTG?

    • As many as 30 genes, including APOC3, influence the level of triglycerides in the blood. Many people with hypertriglyceridemia carry variations in one or more of those genes. Thus, genetic factors may explain high TG levels that are refractory to lifestyle changes and guideline-directed therapy.

    • Some people are highly resistant to current therapies, and their TG levels can be challenging to manage in the clinic.

    • A small percentage of people have familial chylomicronemia syndrome (FCS). They often have extremely high triglyceride levels (>880 mg/dL) that do not respond to current therapies

  • In what studies is Ionis currently recruiting patients who have HTG?

    Ionis is conducting several late-stage clinical studies to evaluate the efficacy and safety of olezarsen in patients with severe HTG on lipid lowering therapy that adheres to local standards of care.

  • What are the eligibility requirements for patients interested in Ionis' late-stage clinical studies?

    Patients may be eligible to participate in CORE or CORE2 if they:

    • Are over 18 years old

    • Are on lipid-lowering therapy that should adhere to standard-of-care per local guidelines

    • Have fasting TG levels ≥500 mg/dL despite ongoing use of standard-of-care lipid-lowering medications Patients with glycated hemoglobin (HbA1C) levels ≥9.5% and/or estimated glomerular filtration rates (eGFRs) of <30 mL/min/m2 at screening are not eligible and other inclusion and exclusion criteria will be evaluated before enrollment.

  • How can my patients enroll in an Ionis HTG study?

    Contact us via email at [email protected] or via phone at (844) 691-2147 for more information.

Questions Your Patients May Have

  • What is severe hypertriglyceridemia?

    Severe hypertriglyceridemia is when a person’s plasma triglyceride levels are 500 mg/dL or higher. The condition can be caused by diet and lifestyle, but many people with severe hypertriglyceridemia also have genes that contribute to high triglyceride levels.

  • Why does severe hypertriglyceridemia need to be treated?

    Unmanaged sHTG is associated with a high risk for atherosclerotic cardiovascular disease and acute pancreatitis. sHTG can also complicate the management of obesity, diabetes and insulin resistance.

  • What is olezarsen?

    Olezarsen is an investigational medicine designed to inhibit liver production of a protein known as apoC-III.

  • Olezarsen is sometimes called an “antisense” technology. What does that mean?

    An antisense technology works by reducing the ability of cells to produce specific disease-causing proteins.

  • Olezarsen is also sometimes called a “ligand-conjugated” investigational drug. What does that mean?

    Part of the olezarsen molecule is designed so that the drug is active only in liver cells and not other cells of the body. This design is intended to reduce the possibility of side effects. Whether the design reduces side effects is unknown until clinical trials are completed.

  • How is olezarsen administered?

    In clinical trials, olezarsen is administered as a subcutaneous injection (an injection under your skin) once a month.

  • Will everyone who participates in the study receive the study drug?

    If your patient is eligible and agrees to participate in the study, they will receive either the study drug or a placebo during the treatment period.

    Even if your patient receives a placebo, they will continue to take other medications that you and your patient have agreed upon beforehand. They will also continue to follow diet and lifestyle recommendations intended to help lower their triglyceride levels.

  • Will participants be reimbursed for transportation, meals and parking?

    All study participants will be reimbursed for miles traveled, parking, and a meal allowance for the days associated with study visits.

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