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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Efficacy, safety, tolerability and quality of life of ongoing individually optimized lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind multicenter phase IV study in participants with hypercholesterolemia

This research study is about helping people with high cholesterol. High cholesterol can increase your risk of heart problems, so finding good ways to manage it is important. This study is testing a new medicine called Inclisiran alongside standard treatments. Researchers want to see if Inclisiran is safe, helps lower 'bad' cholesterol (LDL-C) effectively, improves people's quality of life, and causes fewer side effects like muscle pain compared to current treatments. Participants will receive either Inclisiran or a dummy treatment (placebo) in addition to their regular cholesterol medication. The study aims to find out if this new approach helps more people achieve healthy cholesterol levels and live better.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Novartis Pharma AG
Enrolment target
1,776
Start
05 Jul 2024

What is this study about?

This study is looking into new ways to help people who have high cholesterol. You might know cholesterol as the 'waxy' substance in your blood. While some cholesterol is good for you, too much of a certain type, often called 'bad' cholesterol (LDL-C), can build up in your arteries and cause serious health problems like heart attacks and strokes. So, keeping your cholesterol at a healthy level is really important.

Doctors already have medicines like 'statins' (you might have heard of Rosuvastatin) that work well to lower cholesterol. This study is trying to understand if adding a new medicine called Inclisiran to these existing treatments could be even better. Imagine your current cholesterol medication is like a strong defence; this study wants to see if Inclisiran can be an extra, powerful player on the team. They want to check if it helps more people reach their personal cholesterol targets, and if it makes them feel better overall, without causing new problems.

The main goal is to see how many people can get their 'bad' cholesterol down to a healthier level, which might be less than 55 mg/dL or less than 70 mg/dL, depending on what's right for them. The study also looks closely at whether people experience side effects, especially muscle pain, and how their general well-being and daily activities are affected. This kind of research helps doctors understand the best ways to keep people with high cholesterol healthy and feeling good.

Key takeaways

  • The study explores a new medicine (Inclisiran) for high cholesterol.
  • It aims to see if Inclisiran helps more people reach healthy cholesterol levels.
  • Researchers will compare Inclisiran with standard cholesterol treatments.
  • The study also closely monitors potential side effects, like muscle pain.
  • It will assess how treatments affect patients' quality of life and well-being.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or over. Both men and women can take part. You would also need to have high cholesterol that is currently being treated or needs treatment.

Because this study is looking at how a new medicine works alongside your usual treatment, you would likely already be taking medication for your cholesterol, or be about to start. The research team will need to check your medical history and current health carefully to make sure the study is safe and suitable for 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.

  1. Are you 18 years old or older?
  2. Do you have high cholesterol (hypercholesterolemia)?
  3. Are you currently taking or planning to start cholesterol-lowering medication (like statins)?
  4. Are you able to attend regular clinic visits for about a year?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new medicine (Inclisiran) or a dummy treatment (placebo), along with your ongoing cholesterol medication, such as Rosuvastatin. These will be given as injections. You won't know which one you're receiving, and neither will your study doctor – this is called 'double-blind' and helps ensure the results are fair.

The study will involve several visits to the clinic over about a year (360 days). At these visits, doctors will take blood samples to check your cholesterol levels and carry out regular health checks. They will also ask you questions about how you're feeling, if you have any pain, and how your daily life is going. This helps them understand the effect of the treatment on your overall well-being. There will be initial assessments, regular check-ups, and a final follow-up at the end of the year to see how you're doing.

Potential risks and benefits

Taking part in a study like this could potentially offer benefits like closer medical monitoring and access to a new treatment that might improve your cholesterol control more effectively. However, there are also potential risks, such as side effects from the study medication, including muscle pain, or discomfort from injections and blood tests. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Bulgaria
  • Unverified
    Poland
  • Unverified
    France
  • Unverified
    Estonia
  • Unverified
    Latvia
  • Unverified
    Czechia
  • Unverified
    Spain
  • Unverified
    Germany

Common questions

What is 'bad' cholesterol (LDL-C)?

LDL-C stands for Low-Density Lipoprotein Cholesterol. This is often called 'bad' cholesterol because high levels can lead to blockages in your arteries, increasing your risk of heart disease.

What is Inclisiran?

Inclisiran is a new medicine being tested. It works in a different way to lower cholesterol compared to medicines like statins.

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the real medicine but contains no active drug. It helps researchers compare the real medicine's effects accurately.

Why is muscle pain mentioned?

Muscle pain can sometimes be a side effect of cholesterol-lowering medicines like statins, so the study wants to carefully check if the new medicine causes or changes this type of pain.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor your study doctor will know which treatment you are receiving. This is a common practice to ensure unbiased results.

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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