ISIS 678354-CS6 A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) Administered Subcutaneously to Patients with Severe Hypertriglyceridemia
This study is looking for volunteers with a condition called severe hypertriglyceridemia, which means they have extremely high levels of a type of fat called triglycerides in their blood. High triglycerides can increase the risk of serious health problems, like inflammation of the pancreas. The study is testing a new medicine called Olezarsen, given as an injection under the skin. Half the participants will receive Olezarsen, and the other half will receive a "dummy" injection (placebo) that looks the same but contains no medicine. We want to find out if Olezarsen can effectively lower triglyceride levels and improve other related health markers over 6 to 12 months.
At a glance
What is this study about?
This research study is focused on a condition called severe hypertriglyceridemia, which means having very high levels of a type of fat called triglycerides in your blood. When these levels are too high, it can lead to various health concerns, including a painful condition called acute pancreatitis. We are testing a new medicine named Olezarsen, which is given as an injection just under the skin.
The main goal of this study is to see if Olezarsen can significantly lower triglyceride levels compared to a placebo. A placebo is a harmless substance that looks exactly like the study medicine but doesn't contain any active drug. This helps us understand if the changes we see are truly due to the medicine or other factors. We will be measuring how much triglyceride levels change after 6 months.
Beyond just triglycerides, we'll also be looking at other important things. This includes checking other fat-related substances in the blood, seeing if more people reach safe triglyceride levels, and monitoring for any episodes of pancreatitis. We'll also be using scans to measure fat in the liver. All of this information will help us understand if Olezarsen is a safe and effective treatment option for people with severe hypertriglyceridemia.
Key takeaways
- This study is for adults with very high triglyceride levels.
- It's testing a new injected medicine called Olezarsen.
- Half of participants will get the study medicine, half will get a placebo.
- Researchers want to see if the medicine lowers triglycerides over 6-12 months.
- Participation involves regular clinic visits and monitoring for about a year.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. Both men and women can take part.
Crucially, you must have severe hypertriglyceridemia, meaning your triglyceride levels are very high. The study team will check your recent medical records and conduct specific tests to confirm that your triglyceride levels meet the study's requirements.
There might be other health conditions or medicines that would prevent you from taking part, to ensure your safety and the accuracy of the study results. The study team will go through all these details with you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been told by a doctor that you have very high triglyceride levels?
- Are you able to attend regular clinic appointments for about a year?
- Are you comfortable with receiving injections under your skin?
What does participation involve?
If you decide to join this study, you will be assigned by chance (like flipping a coin) to receive either the study medicine, Olezarsen, or a placebo injection. You, and your study doctor, won't know which one you're receiving. Both are given as an injection under the skin. You will have regular appointments at the clinic over about a year. At these visits, doctors will measure your triglyceride levels with blood tests, check your general health, and ask about any changes you notice.
You will receive the study injection regularly, and there will be follow-up phone calls or visits to monitor your progress and well-being. The total length of your participation in the treatment part of the study will be about 53 weeks, which is roughly one year.
Potential risks and benefits
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Common questions
What are triglycerides?
Triglycerides are a type of fat carried in your blood. High levels can be unhealthy and increase your risk for certain health problems, like pancreatitis.
What does 'severe hypertriglyceridemia' mean?
It means you have extremely high levels of triglycerides in your blood, much higher than what is considered healthy.
What is a 'placebo'?
A placebo is an inactive substance that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers understand if the new medicine is truly effective.
How will the medicine be given?
The study medicine, Olezarsen, or the placebo, will be given as an injection just under your skin.
How long will the study last for me?
Your participation in the main treatment part of the study will last for about 53 weeks, or roughly one year.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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