In short
There is currently 1 ongoing clinical trial investigating new treatments for Type V Hyperlipidaemia, also known as mixed dyslipidemia. This trial is evaluating the long-term safety and effectiveness of an investigational medication called ARO-APOC3, which targets a specific protein involved in fat metabolism. The study is being conducted across multiple European countries and is open to adults who have completed an earlier phase of treatment.
Clinical trial locations
- Hungary
- Netherlands
- Poland
Study on Long-Term Safety and Efficacy of ARO-APOC3 for Adults with Mixed Dyslipidemia
This clinical trial is investigating ARO-APOC3, an investigational treatment for adults with mixed dyslipidemia. The condition is characterized by abnormal levels of fats in the blood, including high levels of bad cholesterol and triglycerides, combined with low levels of good cholesterol. These imbalances can lead to fatty deposits building up in the arteries, increasing the risk of heart attacks and strokes over time.
Main inclusion criteria: This trial is open to adults aged 18 years or older who have already completed a 48-week treatment period in a previous related study. Participants must not be pregnant or breastfeeding, and should not plan to become pregnant during the study. They must be willing and able to provide written informed consent, meaning they understand what participation involves and agree to take part.
Main exclusion criteria: The trial excludes people with certain health conditions that might interfere with the study results, those currently taking medications that could affect outcomes, and individuals who have recently had or are planning major surgery. Pregnant or breastfeeding women cannot participate. People with a history of allergic reactions to similar treatments, severe liver or kidney problems, uncontrolled high blood pressure, unstable heart conditions, or a history of substance abuse are also excluded. Additionally, those currently enrolled in another clinical trial cannot join this study.
Trial focus and goals: The main goal of this study is to evaluate the long-term safety and effectiveness of ARO-APOC3 in managing mixed dyslipidemia. Researchers will primarily monitor participants for any treatment-related adverse events or side effects. They will also measure changes in various blood fat levels, including triglycerides, different types of cholesterol, and specific proteins involved in fat metabolism such as apolipoprotein C-III and apolipoprotein B. The study began recruiting participants in July 2022 and is expected to conclude by September 2025.
Investigational drug: ARO-APOC3 is an RNA interference therapeutic that works by targeting and reducing the production of apolipoprotein C-III, a protein that plays a significant role in how the body processes fats. It is administered as a subcutaneous injection, meaning it is injected under the skin. This type of treatment uses small RNA molecules to interfere with the expression of specific genes involved in regulating fat levels in the blood. By reducing apolipoprotein C-III, ARO-APOC3 may help lower cholesterol and triglyceride levels.
Summary
Currently, there is one active clinical trial for Type V Hyperlipidaemia, focusing on the long-term evaluation of ARO-APOC3. This trial is being conducted across three European countries: Hungary, the Netherlands, and Poland. The study represents an extension of previous research, allowing participants who have already received 48 weeks of treatment to continue and be monitored for longer-term safety and effectiveness.
The trial specifically targets mixed dyslipidemia through a novel RNA interference approach, aiming to reduce a key protein involved in fat metabolism. This represents an innovative treatment strategy for a condition that significantly increases cardiovascular risk. The geographical concentration in Central and Western Europe may reflect regulatory environments and research infrastructure conducive to this type of advanced therapeutic investigation.
