Olezarsen for High Triglycerides
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests olezarsen, a new drug, to see if it can lower blood fat levels in people with high triglycerides. The goal is to help those who may not respond to usual treatments by reducing their blood fat and preventing health problems. Olezarsen is a new drug being tested to address the unmet need for effective triglyceride-lowering treatments, as current medications often fail to achieve normal triglyceride levels.
Will I have to stop taking my current medications?
The trial requires that you stay on your current lipid-lowering medications, as they need to be optimized and stable for at least 4 weeks before the study starts.
Is Olezarsen safe for humans?
The safety of Olezarsen, also known as ISIS 678354 and other names, has been evaluated in clinical trials for lowering triglyceride levels. While specific safety data for Olezarsen is not detailed in the provided research, similar treatments like volanesorsen have been studied for safety in treating high triglycerides, suggesting that Olezarsen may have a similar safety profile.12345
What makes the drug Olezarsen unique for treating high triglycerides?
Olezarsen is unique because it is an antisense oligonucleotide (a type of genetic material that can block specific genes) designed to target and reduce the production of apolipoprotein C-III, a protein that plays a key role in triglyceride metabolism. This approach is different from other treatments like fibrates or statins, which only modestly lower triglyceride levels.12367
What data supports the effectiveness of the drug Olezarsen for high triglycerides?
Research shows that Olezarsen, which targets a protein called apolipoprotein C-III, can lower triglyceride levels in people at high risk for heart disease. Similar drugs, like volanesorsen, have been shown to significantly reduce triglyceride levels and are being tested in advanced clinical trials.12346
Are You a Good Fit for This Trial?
This trial is for people with severe hypertriglyceridemia, a condition with very high levels of triglycerides in the blood. Participants must be on stable lipid-lowering therapy according to local guidelines for at least 4 weeks before joining. They can't join if they have severely impaired kidney function, uncontrolled diabetes (HbA1c ≥ 9.5%), or significantly elevated liver enzymes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive olezarsen or placebo administered subcutaneously every 4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- ISIS 678354
- Olezarsen
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ionis Pharmaceuticals, Inc.
Lead Sponsor
Dr. Brett P. Monia
Ionis Pharmaceuticals, Inc.
Chief Executive Officer since 2020
PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College
Dr. Eric Bastings
Ionis Pharmaceuticals, Inc.
Chief Medical Officer
MD