ISIS 678354-CS5: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of ISIS 678354 Administered Subcutaneously to Patients with Severe Hypertriglyceridemia.
This study is for people who have dangerously high levels of fat, called triglycerides, in their blood. This condition is known as severe hypertriglyceridemia. We are testing a new medicine, ISIS 678354, which is given as an injection under the skin. Some participants will receive the active medicine, while others will receive a dummy injection (placebo) that contains no medicine. This helps researchers understand if the new medicine is effective at lowering triglyceride levels over six months. The study also looks at how the medicine affects other fats in the blood and whether it can help prevent serious health problems like inflammation of the pancreas.
At a glance
What is this study about?
This study, called ISIS 678354-CS5, is looking for a better way to treat a condition called severe hypertriglyceridemia. This is when there's too much of a type of fat, called triglycerides, in your blood. Having very high triglycerides can be unhealthy and increase your risk of certain health problems, like pancreatitis (a painful inflammation of the pancreas).
The main goal of this study is to see if a new medicine, ISIS 678354, can effectively lower these high triglyceride levels. This medicine is given as an injection just under the skin. To make sure the results are reliable, some people in the study will receive the new medicine, while others will get a 'dummy' injection called a placebo. A placebo looks just like the real medicine but contains no active ingredients. This helps researchers compare the treatment group to a group that hasn't received the actual drug. Neither you nor your study doctor will know whether you are receiving the active medicine or the placebo, which helps prevent any bias.
Over roughly one year, the researchers will carefully monitor how the medicine affects your triglyceride levels. They will measure your fasting triglycerides (triglyceride levels after you haven't eaten for a certain period) at different times, especially around six months into the study. They will also check other fats in your blood and keep an eye on how many people experience conditions like pancreatitis. By doing this, they hope to find out if ISIS 678354 is a safe and effective treatment option for severe hypertriglyceridemia.
Key takeaways
- This study is testing a new medicine for very high blood fats (triglycerides).
- It aims to see if the medicine, ISIS 678354, can safely lower triglyceride levels.
- Participants will receive either the new medicine or a dummy injection (placebo).
- The study lasts about one year and involves regular clinic visits and blood tests.
- Both men and women, aged 18 and older with severe hypertriglyceridemia, can participate.
- Your doctor will discuss all details, including benefits, risks, and your right to withdraw.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially take part. Both men and women are welcome to participate.
The most important requirement is that you have a diagnosis of severe hypertriglyceridemia. This means your doctor has confirmed that you have very high levels of triglycerides in your blood. Your doctor will carefully review your health records and conduct some tests to confirm you meet all the specific criteria for the study.
There might be other health conditions or medicines that could prevent you from joining, as the researchers need to make sure the study is safe for everyone involved and that the results are clear. Your study doctor will discuss all the detailed eligibility requirements 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?
- Has your doctor told you that you have severe hypertriglyceridemia (very high blood triglycerides)?
- Are you able to attend regular clinic appointments for about a year?
- Are you comfortable receiving injections under your skin?
- Are you willing to have blood tests done periodically?
What does participation involve?
If you decide to join this study, you will be in it for about one year. During this time, you will have regular visits to the study clinic. These visits will involve blood tests to check your triglyceride levels and other markers, physical exams, and discussions about how you are feeling. You will receive either the new study medicine, ISIS 678354, or a placebo injection (a dummy injection with no active medicine) just under your skin. These injections will be given regularly throughout the study period. You will also have follow-up assessments to see how your body is responding to the treatment. All these steps are carefully planned to understand the effects of the new medicine safely and accurately.
Potential risks and benefits
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Common questions
What are triglycerides?
Triglycerides are a type of fat found in your blood. High levels can increase your risk of certain health problems.
What is a placebo?
A placebo is a 'dummy' injection or pill that looks like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the actual medicine.
How long will I be in the study?
The study will last for about one year, including regular visits and follow-up.
Will I know if I'm getting the real medicine or the placebo?
No, neither you nor your study doctor will know whether you are receiving the real medicine or the placebo. This is to ensure the study results are fair and unbiased.
What does a 'subcutaneous injection' mean?
It means the medicine is injected just under your skin, usually in places like your belly or thigh.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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