SHASTA-3 Study
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 (SHASTA-3 Study)
IRAS ID
1010278
Contact name
Sheldon Mullins
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Eudract number
2023-509300-14
Clinicaltrials.gov Identifier
Research summary
AROAPOC3-3003 is a phase 3, randomised, double blind, multicentre study evaluating subcutaneous (under the skin) injection of a study drug called plozasiran, compared to placebo in adults with Severe hypertriglyceridaemia (SHTG).
SHTG is a disorder characterised by marked elevations in triglyceride (TG) levels, which can lead to acute pancreatitis (AP) and can affect quality of life. SHTG-associated AP is a substantial source of morbidity, mortality, and reduced quality of life. Reduction and maintenance of TG levels can effectively prevent recurrences of pancreatitis. Currently available therapeutic approaches for SHTG are often insufficient to reduce TG levels and prevent AP. Plozasiran has been developed by Arrowhead Pharmaceuticals Inc. as a treatment for dyslipidemias (including SHTG). It works as an RNA interference drug by blocking the creation of a protein called Apolipoprotein C3 (ApoC3). People with severe hypertriglyceridaemia usually have a high level of ApoC3 protein. The ApoC3 protein stops triglycerides from being broken down in the liver. This causes triglycerides to stay in the blood. By blocking the creation of the ApoC3 protein, this aims to lower the level of triglycerides in the blood and in the liver.
The primary objective of the study is to evaluate the efficacy and safety of plozasiran in adults with SHTG. Approximately 405 eligible patients globally will be randomised in a 2:1 ratio to receive subcutaneous injections of either plozasiran 25mg or matching placebo. Participants will receive a total of 4 doses (one dose every 3 months). The total duration for participation is approximately 17 months (up to 8 weeks screening period, 12 months treatment period and 3 months follow-up).
After Month 12, eligible participants will be offered an opportunity to continue in an optional open-label extension (OLE) study, that will last up to 2 years (24 months).
The study is sponsored by Arrowhead Pharmaceuticals, Inc.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0505
Date of REC Opinion
23 Aug 2024
REC opinion
Further Information Favourable Opinion