SHASTA Study
Study Overview
The SHASTA Study is looking at how safe an investigational study drug is and whether it works for people with severe hypertriglyceridemia, also called SHTG. The study drug, called plozasiran, will be compared with a placebo. A placebo looks like the study drug, but contains no actual medicine.
SHTG is a condition in which the level of triglycerides, or fats in the blood, are very high. Triglycerides are the most common types of fat in the human body. They come from foods, such as butter and oil, but are also formed when a person eats more calories than they need. The body converts these extra calories into triglycerides and stores them as fat.
SHTG can:
Put a person at risk of heart disease and blood vessel disease.
Lead to the pancreas becoming swollen over a period of time. When the pancreas becomes quickly swollen, this is called acute pancreatitis.
Hundreds of people in different countries from around the world will take part in these clinical studies. It is important to gather information from all kinds of people who use a certain medication as outcomes can differ based on characteristics such as age, gender, race, and ethnicity. This study plans to enroll a wide variety of people.
Enrollment ends soon! May 23, 2025
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If you are 18 years of age or older
If you have very high blood fat levels (triglycerides >500mg/fl or >5.65mmoI/L).
If you agree to follow diet counseling and maintain a stable low-fat diet during the study.
Please note that this list is not extensive. If you are interested in participating, a staff member will review additional eligibility criteria with you and answer any questions you may have.
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The SHASTA study has 3 periods:
Screening
Study treatment
Follow up
The clinical study will be up to 17 months. You will need to visit the study center up to 12 times. There will also be times you may need to speak by telephone to the study team at the study location.