SHASTA-10
Research type
Research Study
Full title
A Phase 3 Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Plozasiran in Adults with Hypertriglyceridemia (SHASTA-10 Study)
IRAS ID
1011702
Contact name
Yvonne Nguyen
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
Hypertriglyceridemia is a condition where there are high levels of fats called triglycerides in the blood. This condition can cause sudden pain and swelling of the pancreas (called acute pancreatitis) and can affect the quality of life. Patients with hypertriglyceridemia usually have higher levels of a type of protein in the body called APOC3. APOC3 slows down the removal of triglycerides from the blood. Plozasiran is a new type of potential medicine under investigation that can lower the levels of APOC3 in the body. This medicine will be given as an injection and can lower the levels of triglycerides and “bad” cholesterol in the blood. Cholesterol is another type of fat.
This is a multi-centre, open-label extension study. The purpose of this study is to learn more about how safe plozasiran is and how well it works when given for a long time to people with hypertriglyceridemia and severe hypertriglyceridemia. Approximately 840 participants who received plozasiran or placebo in certain previous studies, and who have completed all study requirements, are planned to be enrolled into this study.
All Participants will be given a subcutaenous (under the skin) injection of plozasiran at a specified dose every 3 months. The total duration of the study is approximately 24 months.
The study is sponsored by Arrowhead Pharmaceuticals, Inc.
REC name
London - Chelsea Research Ethics Committee
REC reference
25/LO/0243
Date of REC Opinion
16 May 2025
REC opinion
Further Information Favourable Opinion