Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia (SHASTA-3 Study)
Triglycerides are a type of fat found in your blood. Having extremely high levels can put you at risk of serious health conditions, particularly acute pancreatitis, which is a painful and potentially dangerous swelling of the pancreas. The SHASTA-3 trial is looking at an experimental injection named plozasiran to see if it can lower these blood fats safely and effectively. This is a Phase 3 study, meaning plozasiran has already shown promise in earlier tests and is now being tested in a larger group of adults. Half the participants will get the study drug, and half will receive an inactive dummy injection (placebo). You will have regular clinic visits, health checks, and fasting blood tests over about a year to track your blood fat levels and monitor your overall health.
At a glance
What is this study about?
Triglycerides are fats in your bloodstream that come from food or are made by your liver. While your body needs some triglycerides for energy, having extremely high levels—a condition called severe hypertriglyceridemia—can lead to serious health complications. Most notably, it raises the danger of sudden, severe inflammation of the pancreas, known as acute pancreatitis, which often requires hospital care.
Current treatments do not always lower blood fats enough for people with severe forms of this condition. Plozasiran is an investigational medicine designed to turn down a specific signal in the liver that slows the clearance of fats from the blood. By doing this, scientists hope it helps the body clear triglycerides much more quickly and safely.
The SHASTA-3 study is a Phase 3 clinical trial, the final main stage before a drug can be approved by health authorities. Researchers want to confirm whether plozasiran lowers blood fats significantly over 12 months compared to a placebo, and whether it helps prevent attacks of pancreatitis. By taking part, volunteers help doctors find new, better ways to manage severe blood fat disorders.
Key takeaways
- Tests whether a new injection, plozasiran, lowers very high blood fat levels.
- Aims to reduce the risk of severe pancreas inflammation (acute pancreatitis).
- Lasts about 12 months with monthly clinic visits and fasting blood tests.
- Half of the participants receive the active drug, and half receive a dummy injection.
- Participation is completely voluntary and you can stop at any time.
Who may be eligible?
This study is open to adults aged 18 and over of any sex who have been diagnosed with severe hypertriglyceridemia. This means your blood fat levels remain very high, even if you are already taking standard medications or following a low-fat diet.
To join, you must be willing to attend regular clinic check-ups and have routine blood tests. You will also need to fast (avoid food and drink other than water) for a set number of hours before certain blood tests are taken.
Certain health issues may mean this study is not safe for you. The study doctors will carefully review your full medical history, your current medicines, and your liver and kidney health to decide if taking part is a good and safe fit.
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.
- You are aged 18 or older.
- You have been told you have very high blood fat (triglyceride) levels.
- You are able to attend monthly clinic appointments over a 12-month period.
- You are comfortable having regular blood tests while fasting.
- You are willing to receive injections under the skin.
What does participation involve?
Taking part lasts for just over one year (around 12 months). During this time, you will visit the hospital or research clinic roughly once a month. At these appointments, the medical team will check your blood pressure, monitor your heart, and take blood samples after an overnight fast to measure your fat and cholesterol levels.
You will receive regular injections under the skin. Because this is a double-blind trial, neither you nor your study doctor will choose or know whether you receive plozasiran or an inactive dummy injection (placebo). If you feel unwell or have any symptoms of pancreas pain at any point, the medical team will assess you promptly.
Potential risks and benefits
Locations (10)
- —UnverifiedPoland
- —UnverifiedBelgium
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedSlovakia
- —UnverifiedCroatia
- —UnverifiedItaly
- —UnverifiedHungary
- —UnverifiedBulgaria
- —UnverifiedRomania
Common questions
What is severe hypertriglyceridemia?
It is a medical term for having extremely high levels of triglycerides, which are fats found in the blood. Very high levels increase the risk of pancreatitis and heart problems.
What is a placebo?
A placebo is an inactive substance that looks just like the real medicine. Comparing the study drug to a placebo helps researchers know if changes in health are truly caused by the drug.
Will taking part cost me anything?
No, the study medicine, visits, and tests are provided free of charge. Most trials also offer help with reasonable travel expenses to and from the clinic.
Can I leave the trial if I change my mind?
Yes, you can leave the study at any time without giving a reason. Leaving will not change your relationship with your doctor or the normal care you receive.
How is the study drug given?
Plozasiran is given as an injection just under the skin, usually in your tummy, thigh, or upper arm, using a pre-filled syringe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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