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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 Severe Hypertriglyceridemia (SHASTA-4 Study)

Triglycerides are a type of fat found in your blood. While your body needs some, having extremely high levels can lead to serious health complications, such as acute pancreatitis, which is a sudden and painful swelling of the pancreas. The SHASTA-4 clinical study is testing an investigational medicine called plozasiran. Researchers want to find out if regular injections of plozasiran can safely and effectively reduce blood fat levels in adults over a 12-month period. Participants will be placed into groups by chance. One group will receive plozasiran, while the other will receive an inactive dummy injection called a placebo. Neither the participants nor the research doctors will know who gets which treatment. Regular health checks and fasting blood tests will measure changes in fat levels and track participants' overall health throughout the study.

At a glance

Status
Recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Arrowhead Pharmaceuticals Inc.
Enrolment target
138
Start
23 Sep 2024

What is this study about?

When we eat, our bodies convert unused energy into fats called triglycerides, which circulate in the bloodstream. While everyone has some triglycerides, having extremely high levels is known medically as severe hypertriglyceridaemia. This condition often causes no everyday symptoms, but it significantly increases the risk of acute pancreatitis. Pancreatitis is a severe, sudden inflammation of the pancreas that often requires emergency hospital treatment.

Managing very high blood fats through diet and currently available medicines can sometimes be difficult. The SHASTA-4 study is exploring a new medicine called plozasiran. Plozasiran is designed to help the body break down and clear fats from the bloodstream more effectively. Researchers want to see if this treatment can bring blood fats down to much safer levels.

This is a Phase 3 study, which means the drug has already passed early safety checks in smaller groups of people. Researchers now need to test it in a larger group of adults to confirm how well it works and to watch for any unexpected side effects. To make the results fair and reliable, plozasiran is being compared against a placebo, which looks identical but has no active ingredients.

By taking part, participants help doctors learn whether plozasiran can become a useful new treatment option. If successful, this medicine could give people with very high blood fats a reliable way to protect their pancreas and support their long-term health.

Key takeaways

  • The study tests an investigational injection called plozasiran to treat severely high blood fats.
  • The main goal is to see if plozasiran safely lowers triglycerides over 12 months.
  • Lowering blood fats may help prevent serious conditions like acute pancreatitis.
  • Participants are assigned by chance to receive either plozasiran or an inactive dummy injection (placebo).
  • Participation requires regular clinic visits and fasting blood tests over roughly one year.

Who may be eligible?

This study is designed for adults aged 18 and older who have been diagnosed with severely high blood fats (triglycerides). Both men and women can take part.

Because this study focuses on extreme levels of blood fat, people with only mildly raised triglycerides will not be able to join. The study team will need to review your medical history to make sure taking part is safe for you. Certain existing medical conditions or treatments might mean this trial is not suitable.

Before you can join, the study doctors will carry out special fasting blood tests. These tests measure the exact amount of fat in your blood and ensure you meet all the health rules required for the trial.

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. I am aged 18 or older.
  2. I have been told by a doctor that I have very high blood fats (severe hypertriglyceridaemia).
  3. I am willing to receive regular injections under the skin.
  4. I am able to attend regular clinic appointments and have fasting blood tests over 12 months.
  5. I am comfortable with the possibility of receiving a placebo (dummy treatment).
Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for at least 12 months. During this time, you will receive regular injections just under the skin. You will be assigned by chance (randomised) to receive either the study medicine, plozasiran, or a dummy treatment (placebo). You will need to visit the study clinic or hospital regularly for health reviews. These visits will involve physical check-ups, questions about how you are feeling, and fasting blood tests, where you avoid eating for a set time before your blood is drawn. The study doctors will carefully monitor your blood fat levels, your cholesterol, and your general health throughout the entire year.

Potential risks and benefits

A potential benefit of joining this study is that the treatment may help lower your blood fats, and you will receive regular, detailed health monitoring from a specialist team. However, there is no guarantee you will get the active medicine, as you might receive the placebo, and the medicine may not work for everyone. Potential risks include side effects from the injections, such as soreness, redness, or swelling where the needle enters the skin, as well as unknown reactions to the study drug. Taking part is completely voluntary. You have the right to leave the trial at any point, and doing so will not affect your usual NHS care.

Locations (10)

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

Common questions

What is a placebo and why is it used?

A placebo is a harmless dummy treatment that looks just like the real medicine but contains no active drug. It allows researchers to see if changes in health are truly caused by the study medicine rather than other factors.

Will I know if I am getting plozasiran or the placebo?

No. This is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until the trial is finished. In a medical emergency, the doctors can find out quickly.

Will taking part in this study cost me anything?

No. The study medication, tests, and clinic visits are provided free of charge. Many clinical trials also help cover reasonable travel expenses to and from the clinic.

Can I still take my usual medicines?

In many cases, yes, but you must share a full list of all your current prescriptions and over-the-counter supplements with the study team so they can ensure they are safe to take together.

What happens if I change my mind during the study?

You are free to stop participating at any time without giving a reason. Your regular doctors will continue to look after your health as normal.

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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