This clinical trial focuses on patients with Severe Hypertriglyceridemia, a condition characterized by very high levels of triglycerides (fats) in the blood. The study will test a medication called ISIS 678354 (also known as olezarsen), which is an antisense oligonucleotide – a type of drug that can influence how genes work in the body.
The purpose of this research is to determine how well ISIS 678354 works compared to placebo in reducing triglyceride levels in the blood. During the study, participants will receive either ISIS 678354 or placebo as an injection under the skin (subcutaneous injection). The treatment will continue for approximately 12 months, with regular monitoring of blood triglyceride levels and other health parameters.
The medication will be given alongside standard lipid-lowering treatments that patients are already taking. Throughout the study, researchers will measure various factors related to blood fats, including substances called Apolipoprotein C-III and different types of cholesterol. They will also monitor patients for potential health complications and check the amount of fat in the liver.
1Initial medical assessment
Your fasting triglyceride levels will be checked to confirm they are at least 500 mg/dL
Your current lipid-lowering medications will be reviewed – they should be stable for at least 4 weeks before starting
2Treatment assignment
You will be randomly assigned to receive either olezarsen (ISIS 678354) or placebo
Neither you nor your doctor will know which treatment you are receiving
3Treatment period – first 6 months
You will receive subcutaneous injections (shots under the skin)
Your triglyceride levels will be measured regularly
Key measurements will be taken at weeks 25 and 27
4Treatment period – months 7-12
Treatment continues with regular injections
Additional measurements will include:
– Triglyceride levels
– Apolipoprotein C-III (a protein that affects fat processing)
– Remnant cholesterol
– Non-HDL cholesterol
Your liver fat content will be measured
5Final assessment
Final measurements will be taken at week 53
Your overall response to treatment will be evaluated
Your triglyceride levels will be compared to the starting values
Who Can Join the Study?
Must be 18 years of age or older
Must have high levels of triglycerides (fats in the blood) of at least 500 mg/dL when measured after fasting
Must be currently taking lipid-lowering medications (medicines that help reduce fats in the blood) according to standard medical guidelines
Must have been on a stable dose of lipid-lowering medications for at least 4 weeks before starting the screening process
Both men and women can participate in the study
Must be willing to continue taking current lipid-lowering medications throughout the study period
Must be able to provide fasting blood samples (not eating or drinking anything except water for several hours before blood tests)
Who Cannot Join the Study?
Age below 18 years or above 75 years
Pregnant or breastfeeding women
History of acute pancreatitis (inflammation of the pancreas) within the past 6 months
Current use of medications that can significantly affect triglyceride levels (blood fats)
Uncontrolled diabetes (blood sugar levels not well managed)
Severe kidney disease or requiring dialysis
Severe liver disease
History of heart attack or stroke within the past 6 months
Active cancer or cancer treatment within the past 5 years
Participation in another clinical trial within the past 30 days
Known allergies to the study medication or its components
Alcohol or substance abuse within the past year
Mental conditions that could interfere with study compliance
Unstable medical conditions that could affect study results
Olezarsen (also known as ISIS 678354) is a medication being studied for treating severe hypertriglyceridemia, a condition where there are very high levels of triglycerides (fats) in the blood. This medication is given as an injection under the skin (subcutaneously) and works by helping to reduce triglyceride levels in the bloodstream. It represents a new approach to treating patients who have difficulty controlling their triglyceride levels with currently available treatments.
Severe Hypertriglyceridemia – A metabolic disorder characterized by abnormally high levels of triglycerides (fat molecules) in the blood, specifically above 500 mg/dL. The condition develops when the body produces too many triglycerides or cannot break them down effectively. Excess triglycerides can accumulate in various organs, particularly the liver and pancreas. The condition can be inherited genetically or develop due to other health conditions. People with this disorder often have difficulty processing fats from their diet, leading to their accumulation in the bloodstream.
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