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.
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
Olezarsen is an investigational ligand-conjugated antisense (LICA) medicine consisting of:
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?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.
Patients may be eligible to participate in CORE if they:
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.
Associated Risks of Unmanaged Elevated Triglycerides
Baylor College of Medicine cardiologist Dr. Christie Ballantyne explains the associated health risks of unmanaged elevated triglycerides.
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 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.
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.
Share your contact information below and receive a free
informational flyer about hypertriglyceridemia and genetics -
in addition to informational fact sheets about the CORE and CORE2 clinical trials.
Intended for US healthcare professionals only.