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RecruitingTherapeutic confirmatory (Phase III)Interventional

Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Hypertriglyceridemia (MUIR-3 Study)

The MUIR-3 study is testing a new medicine called plozasiran for adults with hypertriglyceridemia, which means having unusually high levels of fats (triglycerides) in the blood. High levels of these fats can increase the risk of heart disease and pancreatitis. Plozasiran is designed to help the liver clear fat from the bloodstream more effectively. In this Phase 3 trial, doctors are comparing plozasiran injections against a dummy treatment called a placebo. Neither the participants nor the research team will know who receives the real medicine. Participants will have regular health checks and fasting blood tests over at least 12 months to measure changes in their blood fats. The goal is to see if plozasiran is safe, works well, and can bring fat levels down to a healthy range. Taking part is voluntary, and participants can leave the study at any time.

At a glance

Status
Recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Arrowhead Pharmaceuticals Inc.
Enrolment target
478
Start
07 Oct 2024

What is this study about?

Triglycerides are a type of fat found in your blood. When you eat, your body turns any calories it does not need into triglycerides and stores them in fat cells. While having some triglycerides is completely normal and healthy, having levels that are too high can cause health problems. Very high blood fats can narrow blood vessels, increasing the chance of heart attacks and strokes, and can also trigger painful inflammation in the pancreas, known as pancreatitis.

This clinical trial is testing an experimental medicine called plozasiran. Plozasiran works by switching off a specific signal in the liver that normally stops the body from clearing fats quickly. By calming down this signal, the medicine aims to help your body break down and remove triglycerides and 'bad' cholesterol from your bloodstream much more quickly.

Doctors are running this study to see if plozasiran works better than a dummy treatment (placebo) over a full year. Because this is a Phase 3 study, plozasiran has already been tested in smaller groups of people. Researchers now need to test it in a larger group to confirm that it is effective, reliable, and safe for wider use in the future.

Key takeaways

  • The MUIR-3 trial is testing plozasiran, a new injection designed to reduce high blood fats.
  • The study compares plozasiran against an inactive dummy injection (placebo).
  • Open to adults aged 18 and older diagnosed with high triglycerides.
  • Participation involves regular clinic visits, health checks, and fasting blood tests over at least 12 months.
  • Taking part is completely voluntary and will not affect your standard NHS treatment.

Who may be eligible?

This trial is open to adults aged 18 and over who have been diagnosed with high blood fats (hypertriglyceridemia). Both men and women can join.

To see if the study is suitable for you, doctors will check your blood fat levels and review your general medical history. People with certain underlying health conditions, or those taking specific medications that could interfere with the study medicine, may not be able to take part.

A study doctor will talk through the complete medical checklist with you to make sure it is safe for you to participate before any tests or injections begin.

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. You are aged 18 or older.
  2. You have high levels of blood fats (hypertriglyceridemia).
  3. You are willing to receive injections under the skin.
  4. You can attend regular clinic appointments over at least 12 months.
  5. You are happy to have fasting blood tests taken during clinic visits.
Answer every question to see your result.

What does participation involve?

Taking part in the MUIR-3 study lasts for around a year or slightly longer. You will receive either the study medicine (plozasiran) or a dummy injection (placebo) into the skin at scheduled intervals. You will not be able to choose which one you receive.

Throughout the study, you will need to attend regular clinic visits. At these visits, doctors and nurses will check your general health, measure your blood pressure, and take blood samples. You will be asked to fast (avoid food and drink other than water) before some blood tests so your fat levels can be measured accurately. The study team will monitor you closely for any changes in your health or any side effects throughout your time on the trial.

Potential risks and benefits

Taking part may help lower your blood fat levels, although there is a chance you will receive the placebo, which contains no active medicine. The information gathered may also help doctors find better treatments for others in the future. As with any new medicine, there is a risk of side effects, such as redness or soreness where the injection is given, or other unexpected symptoms. Your health will be carefully watched throughout the trial. Taking part is completely your choice, and you can leave at any time without it affecting your standard NHS medical care.

Locations (9)

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

Common questions

What are triglycerides?

Triglycerides are common fats carried in your blood. Having too much of this fat can increase the risk of heart problems and pancreas inflammation.

What is a placebo?

A placebo looks just like the real medicine but contains no active ingredients. It helps researchers prove whether any health improvements are truly caused by plozasiran.

How is plozasiran given?

Plozasiran is given as an injection under the skin using a pre-filled syringe during your study clinic visits.

Will I have to pay to take part?

No, clinical trial medicines and study tests are provided free of charge, and travel costs to clinic visits are often reimbursed.

Can I stop taking part if I change my mind?

Yes, you are free to leave the trial at any point, for any reason, and your normal healthcare will continue as usual.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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