Hyperchylomicronaemia – European Clinical Trials Information Network

Study of ISIS 678354 for Patients with Severe High Triglycerides

Wed, 29 Apr 2026 15:05:08 +0000

This clinical trial is focused on studying a condition known as severe hypertriglyceridemia, which is characterized by very high levels of triglycerides in the blood. Triglycerides are a type of fat found in the blood, and having too much can increase the risk of heart disease and other health issues. The study will test a treatment called olezarsen, also known by its code name ISIS 678354. Olezarsen is administered through a subcutaneous injection, which means it is injected under the skin. The study will compare the effects of olezarsen to a placebo, which is an inactive substance used to assess the treatment’s effectiveness.

The purpose of the study is to evaluate how well olezarsen works in reducing the levels of fasting triglycerides from the start of the study. Participants will receive either olezarsen or a placebo and will be monitored over a period of time to see how their triglyceride levels change. The study will also look at other factors, such as changes in certain proteins and cholesterol levels, and the occurrence of any related health events.

Participants in the study will be required to follow a specific diet and lifestyle, and they will continue their current lipid-lowering therapy, which is a treatment to help manage fat levels in the blood. The study will last for about 53 weeks, during which time participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to determine if olezarsen can effectively lower triglyceride levels and improve overall health outcomes for those with severe hypertriglyceridemia.

Study on the Effects of ISIS 678354 in Patients with Familial Chylomicronemia Syndrome (FCS)

Wed, 29 Apr 2026 15:00:48 +0000

This clinical trial is focused on studying a rare genetic disorder called Familial Chylomicronemia Syndrome (FCS). FCS is a condition that affects the body’s ability to break down fats, leading to very high levels of fat in the blood. The treatment being tested in this study is an injection called ISIS 678354, also known as AKCEA-APOCIII-LRx. This medication is designed to help reduce the levels of triglycerides, which are a type of fat found in the blood.

The purpose of the study is to evaluate how well ISIS 678354 works in lowering triglyceride levels in patients with FCS. Participants in the study will receive the medication through a small injection under the skin, using a device called YpsoMate. This device is a single-use, disposable injection system that helps deliver the medication safely and effectively. The study will monitor changes in triglyceride levels over time, as well as the safety and tolerability of the treatment.

Throughout the study, participants will have their triglyceride levels checked at various intervals, such as at 6 months, 12 months, 24 months, and 36 months. The study will also look at other factors, like changes in other blood fats and the occurrence of any side effects. The goal is to see if the treatment can help achieve significant reductions in triglyceride levels and improve the overall health of patients with Familial Chylomicronemia Syndrome.

Study of Olezarsen (ISIS 678354) in Patients with Severe Hypertriglyceridemia: Testing Effects on Triglyceride Levels

Wed, 29 Apr 2026 14:28:49 +0000

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.

Study of ISIS 678354 for Patients with Familial Chylomicronemia Syndrome Previously Treated with Volanesorsen

Wed, 29 Apr 2026 14:25:51 +0000

This clinical trial is focused on studying a rare condition called Familial Chylomicronemia Syndrome (FCS). FCS is a genetic disorder that affects the body’s ability to break down fats, leading to high levels of fat in the blood. The study involves a treatment called AKCEA-APOCIII-LRx, also known by its code name ISIS 678354. This treatment is given as an injection under the skin and is being tested in patients who have previously been treated with another medication called Volanesorsen (ISIS 304801).

The purpose of the study is to evaluate the safety and tolerability of ISIS 678354 in patients with FCS. Participants will receive the treatment over a period of time, and researchers will monitor them for any changes in their health. The study will look at how well patients tolerate the treatment and any side effects they may experience. This includes checking for changes in blood components like platelets and kidney function, as well as any bleeding events.

Throughout the study, researchers will also measure the levels of certain fats in the blood, such as triglycerides and cholesterol, to see how they change with the treatment. The study will last for several months, with regular check-ups to ensure the safety and well-being of the participants. The ultimate goal is to gather information that could help improve treatment options for people living with FCS.