Advancing Hypertriglyceridemia Treatment - Olezarsen Clinical Trials

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

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HELP ADVANCE RESEARCH FOR
PATIENTS SUFFERING FROM SEVERE
HYPERTRIGLYCERIDEMIA (sHTG)

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.

WHAT IS THE ESSENCE TRIAL?

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.

Videos

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
Locations

CORE
CORE2
  • location icon

    Velocity Clinical Research

    Chula Vista, California
    91911, United States

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    Diabetes/Lipid Management & Research Center

    Huntington Beach, California
    92648, United States

  • location icon

    America Clinical Trials

    Tarzana, California
    91356, United States

  • location icon

    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

  • location icon

    Bayside Clinical Research

    Trinity, Florida
    34655, United States

  • location icon

    IACT Health

    Columbus, Georgia
    31904, United States

  • location icon

    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

  • location icon

    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

  • location icon

    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

  • location icon

    Summit Research Group, LLC

    Munroe Falls, Ohio
    44262, United States

  • location icon

    Hightower Clinical Trial Services

    Oklahoma City, Oklahoma
    73102, United States

  • location icon

    Velocity Clinical Research

    Medford, Oregon
    97504, United States

  • location icon

    Health Concepts

    Rapid City, South Dakota
    57702, United States

  • location icon

    Velocity Clinical Research

    Cedar Park, Texas
    78613, United States

  • location icon

    University of Texas Southwestern

    Dallas, Texas
    75390, United States

  • location icon

    Baylor College of Medicine

    Houston, Texas
    77030, United States

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    Velocity Clinical

    West Jordan, Utah
    84088, United States

  • location icon

    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

  • location icon

    Monash Medical Centre

    Clayton S, Victoria
    3168, Australia

  • location icon

    Medical Center Doctor Staykov EOOD

    Burgas,
    8008, Bulgaria

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    Medical Center Diamedical 2013 OOD

    Dimitrovgrad
    6400, Bulgaria

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    MHAT “Dr. Tota Venkova” AD

    Gabrovo
    5300, Bulgaria

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    Medical Center “Hera” EOOD

    Montana
    3400, Bulgaria

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    Medical Center Smolyan Clinical Research OOD

    Smolyan
    4700, Bulgaria

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    Medical Center Endomedical EOOD

    Sofia
    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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    Ecogene-21

    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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    MEDICUS SERVICES s.r.o.

    Brandýs Nad Labem
    250 01, Czechia

  • location icon

    EDUMED s.r.o.

    Náchod
    547 01, Czechia

  • location icon

    Interni Ambulance

    Uherské Hradiště
    686 01, Czechia

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    Aalborg University Hospital

    Aalborg
    9000, Denmark

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    Esbjerg Hospital

    Esbjerg
    6700, Denmark

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    Bispebjerg Hospital

    Frederiksberg
    2000, Denmark

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    Herlev Hospital

    Herlev
    2730, Denmark

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    Hôpital Louis Pradel

    Bron
    69677, France

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    CHU Dijon Bourgogne

    Dijon
    21079, France

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    Hopital de la Conception

    Marseille
    13005, France

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    CHU Nantes – Hopital Nord Laennec

    Saint-Herblain
    44093, France

  • location icon

    BKS Research Kft

    Hatvan, Heves
    3000, Hungary

  • location icon

    Medifarma 98 Kft

    Nyíregyháza, Szabolcs-Szatmar-Bereg
    4400, Hungary

  • location icon

    CRU Hungary Kft

    Borsod
    3860, Hungary

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    Debreceni Egyetem Klinikai Kozpont Belgyogyaszat A epulet

    Debrecen
    4032, Hungary

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    Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

    Szekesfehervar
    8000, Hungary

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    DRC Gyogyszervizsgalo Kozpont Kft

    Veszprém
    8230, Hungary

  • location icon

    Rabin Medical Center

    Petach Tikva
    4941492, Israel

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    Ospdale E. Bassini

    Milano
    20092, Italy

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    A.O. Policlinico Universitario P. Giaccone

    Palermo
    90127, Italy

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    Policlinico Umberto

    Roma
    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

    Christchurch
    8011, New Zealand

  • location icon

    Lipid Clinic

    Oslo
    0586, Norway

  • location icon

    Salvia

    Katowice
    40-772, Poland

  • location icon

    Praktyka Lekarska Ewa Krzyzagorska

    Poznan
    61-655, Poland

  • location icon

    ClinMedica Research Sp.z o.o.

    Skierniewice
    96-100, Poland

  • location icon

    Futuremeds sp. z o.o

    Wroclaw
    50-088, Poland

  • location icon

    Instytut Centrum Zdrowia Matki Polki Klinika

    Łódz
    93-338, Poland

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    Hospital Egas Moniz – Centro Hospitalar de Lisboa Ocidental

    Lisbon
    1349-019, Portugal

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    Nemocnica s poliklinikou Brezno

    Brezno
    97701, Slovakia

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    Iatros International

    Bloemfontein, Free State
    9301, South Africa

  • location icon

    Unitas Hospital

    Centurion, Gauteng
    157, South Africa

  • location icon

    Dr Jan Engelbrecht and Ass. Inc

    Cape Town, Western Cape
    7130, South Africa

  • location icon

    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

    Barcelona
    08041, Spain

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    Hospital Clinic Barcelona

    Barcelona
    8063, Spain

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

    Barcelona
    8208, Spain

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    Hospital Universitari de Bellvitge

    Barcelona
    8907, Spain

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    Hospital Universitario Reina Sofia

    Córdoba
    14004, Spain

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    Hospital Universitario

    Madrid
    28041, Spain

  • location icon

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

    Sevilla
    41013, Spain

  • location icon

    Sahlgrenska, University Hospital

    Goteborg, Västra Götalands Län
    413 45, Sweden

  • location icon

    Karolinska University Hospital Huddinge

    Stockholm
    14186, Sweden

  • location icon

    Huddersfield Royal Infirmary

    Lindley, Huddersfield
    HD3 3EA, United Kingdom

  • location icon

    Hull Royal Infirmary

    Hull
    HU3 2JZ, United Kingdom

  • location icon

    Finlay Medical Research

    Greenacres City, Florida
    33467, United States

  • location icon

    Columbus Clinical Services

    Miami, Florida
    33125, United States

  • location icon

    Harmony Clinical Research, Inc

    North Miami Beach, Florida
    33162, United States

  • location icon

    Combined Research Orlando Phase I-IV

    Orlando, Florida
    32807, United States

  • location icon

    3Sync Research

    Sunrise, Florida
    United States, 33325

  • location icon

    R & B Medical Center LLC

    Tampa, Florida
    33614, United States

  • location icon

    The Research Group of Lexington, LLC

    Lexington, Kentucky
    40503, United States

  • location icon

    Louisville Metabolic and Atherosclerosis Research Center (L-MARC)

    Louisville, Kentucky
    40213, United States

  • location icon

    Grace Research, LLC

    Bossier City, Louisiana
    71111, United States

  • location icon

    Clinical Trials of America LA, LLC

    Monroe, Louisiana
    71201, United States

  • location icon

    Clinical Trials of America, LLC

    Lenoir, North Carolina
    28645, United States

  • location icon

    SV Research LLC

    Marion, Ohio
    43302, United States

  • location icon

    Main Street Physicians Care Waterway

    Little River, South Carolina
    29566, United States

  • location icon

    Juno Research

    Houston, Texas
    77040, United States

  • location icon

    Juno Research

    Houston, Texas
    77054, United States

  • location icon

    Pioneer Research Solutions, Inc

    Houston, Texas
    77099, United States

  • location icon

    FMC Science

    Lampasas, Texas
    76550, United States

  • location icon

    Texas Institute of Cardiology

    McKinney, Texas
    75071, United States

  • location icon

    Southern Endocrinology Associates

    Mesquite, Texas
    75149, United States

  • location icon

    Permian Research Foundation

    Odessa, Texas
    79761, United States

Frequently
Asked
Questions

  • 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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    35. ClinicalTrials.gov A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, or With Severe Hypertriglyceridemia. ClinicalTrials.gov identifier: NCT05610280. Accessed March 13, 2023. Updated March 1, 2023. https://clinicaltrials.gov/ct2/show/NCT05610280