About the SHASTA Study

SHASTA Study
SHASTA Study
SHASTA Study
SHASTA Study

What is the SHASTA Study?

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 type of fat in the human body. Triglycerides 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 (an organ in your belly that helps you digest your food) 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.

What to expect

The SHASTA Study has 3 periods: screening, study treatment, and follow-up. Your total time in 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.

Several tests and assessments will be performed to monitor your health. These will include:

  • Diet and nutrition counseling
  • Acute pancreatitis counseling
  • Physical examinations
  • Measurements of vital signs, including blood pressure, heart rate, breathing rate, and body temperature
  • Urine tests
  • Pregnancy tests, if applicable.

1

Screening period 

  • Up to 8 weeks
  • Up to 3 visits to the study center
2

Study treatment period 

  • About 12 months
  • Up to 8 visits to the study center and 3 phone calls for study assessments
  • At some visits, you will receive the study drug or placebo as an injection under the skin
3

Follow-up period

After the 12-month study treatment period is complete, you can decide to:

  • attend 1 safety follow-up visit 3 months after your last visit, or
  • join an open-label extension (OLE) study, in which everyone will receive the study drug