AROAPOC3-3011 SHASTA-5
Research type
Research Study
Full title
Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
IRAS ID
1013825
Contact name
Jennifer Hellawell
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals Inc.
Eudract number
2024-518206-40
Clinicaltrials.gov Identifier
Research summary
Severe hypertriglyceridaemia (sHTG) is a condition where there are high levels of fats, called triglycerides, in one’s blood. This can cause the pancreas, an organ in the belly, to suddenly become painful and swollen, known as acute pancreatitis. The risk of developing acute pancreatitis is higher for those with a history of the condition and/or with higher levels of triglycerides. Plozasiran is a new medicine under investigation that can lower the levels of triglycerides in the blood.
The purpose of this study is to learn more about how well plozasiran works and how safe it is in people with severe hypertriglyceridemia who have a history of acute pancreatitis. The main treatment period is randomised, double-blind, placebo-controlled. Placebo-controlled means that the effect of an injection of study medicine will be compared with an injection of placebo. The placebo is a liquid that looks like the study medicine, but it is a weak salt solution and does not contain any drug. Study participants will be placed into the study medicine or placebo group by chance (randomised). Half of the participants will receive plozasiran and the other half will receive placebo. “Double blind” means that neither the participants, nor the study doctors will know who is given the study medicine or the placebo. Plozasiran or placebo is given as an injection under the skin every 3 months.
The study has three parts: first, a 6-week screening period; second, the main treatment period estimated to be 12-36 months; and third, a 12-month period where all participants receive plozasiran. Total participation is about 25-50 months.
Up to 288 participants will join the study.
The main treatment period ends when at least 20 people have confirmed acute pancreatitis. After this, or if someone has an acute
pancreatitis event, they will move to the 12-month period where they will get plozasiran injections every 3 months.This study is sponsored by Arrowhead Pharmaceuticals, Inc.
REC name
London - Westminster Research Ethics Committee
REC reference
26/LO/0261
Date of REC Opinion
5 May 2026
REC opinion
Further Information Favourable Opinion