ISIS 678354-CS9: A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study of Olezarsen (ISIS 678354) in Patients with Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), or with Severe Hypertriglyceridemia
This study is looking into a new medicine called Olezarsen. It's for people who have high levels of a type of fat called 'triglycerides' in their blood, and also have heart and blood vessel conditions, or are at high risk of developing them. The main goal is to find out if Olezarsen can effectively lower these triglyceride levels compared to a dummy treatment (placebo) over 25 weeks. Researchers will also check its effects after a year and look at other types of fats, like cholesterol. An important part of the study is to make sure the medicine is safe and if there are any side effects. This information will help doctors understand if Olezarsen could be a helpful new treatment option.
At a glance
What is this study about?
Imagine your body needs fuel, and some of that fuel comes from fats. Triglycerides are a common type of fat found in your blood. Having too much of them, a condition called 'hypertriglyceridemia,' can be bad for your health, especially your heart. This study is testing a new medicine called Olezarsen, which is hoped to help lower these high triglyceride levels.
The study includes people who have high triglycerides and either already have heart and blood vessel problems (like hardening of the arteries, known as atherosclerosis) or are at a higher risk of getting them. It's a 'Phase 3' study, which means it's one of the final steps in testing a new medicine. This phase is crucial because it helps confirm if the medicine works, how well it works compared to current treatments or no treatment, and if it's safe for general use.
Researchers will compare Olezarsen to a 'placebo' – which looks just like the real medicine but contains no active drug. This is important to ensure any changes we see are truly due to Olezarsen and not just because someone is taking *something*. They’ll be looking closely at how much the triglyceride levels change over several months, and also checking other fat levels and overall safety.
Key takeaways
- This study tests a new medicine, Olezarsen, for high blood fats (triglycerides).
- It's for people with, or at risk of, heart and blood vessel problems.
- The study compares Olezarsen to a dummy treatment (placebo).
- It aims to see if Olezarsen lowers triglycerides and is safe.
- Participation involves regular clinic visits and blood tests over about a year.
Who may be eligible?
This study is open to adults aged 18 and over, both men and women. You might be able to take part if you have a condition called 'hypertriglyceridemia,' which means you have very high levels of a type of fat called triglycerides in your blood.
In addition to high triglycerides, you would need to either already have heart and blood vessel disease (like blocked or hardened arteries), or be at an increased risk of developing these conditions. The study team will check your medical history and current health carefully to see if you meet all the requirements for joining.
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?
- Do you have high levels of triglycerides in your blood?
- Do you have existing heart or blood vessel disease?
- Are you at an increased risk of developing heart or blood vessel disease?
What does participation involve?
If you decide to take part, you'll be given either the new medicine, Olezarsen, or a dummy treatment (placebo) as an injection. Neither you nor your study doctor will know which one you are receiving – this is called a 'double-blind' study and helps ensure fair results. You will have regular visits to the clinic over a period of about a year, specifically at 25 weeks (about 6 months) and 53 weeks (about a year).
During these visits, the study team will carry out various assessments. This includes blood tests to measure your triglyceride levels and other fats, checking your vital signs (like blood pressure and heart rate), physical examinations, and possibly ECGs (heart tracings). You'll also be asked about any new symptoms or side effects you might experience. The total duration of active treatment and follow-up for the main part of the study is a bit over a year.
Potential risks and benefits
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Common questions
What are triglycerides?
Triglycerides are a type of fat in your blood. High levels can increase your risk of heart disease.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the real medicine but has no active drug. It helps us see if the new medicine really makes a difference.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your doctor will know. This helps ensure fair and unbiased results.
How long will I need to be in the study?
The main part of the study involves treatment and follow-up over approximately one year.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
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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