MUIR-3 STUDY
Research type
Research Study
Full title
Title of Study: Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Hypertriglyceridemia (MUIR-3 Study)
IRAS ID
1010277
Contact name
Sheldon Mullins
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Eudract number
2023-509302-30
Clinicaltrials.gov Identifier
Research summary
AROAPOC3-3009 is a phase 3, randomised, double-blind, multicentre study evaluating subcutaneous (under the skin) injections of a study drug called plozasiran, compared to placebo in adults with hypertriglyceridaemia (HTG).
Heart attacks and stroke (Atherosclerotic cardiovascular disease or ASCVD) is the leading cause of death worldwide and is associated with substantial illness and healthcare costs. Elevated concentration of low-density lipoprotein cholesterol (LDL-C) is an established risk factor for ASCVD and a primary target for prevention of major adverse cardiovascular events. However, even with currently available LDL-C reducing therapeutics, considerable residual cardiovascular disease risk remains, with epidemiologic support for some of this risk being due to hypertriglyceridemia (HTG), i.e, elevated triglyceride (TG) and TG-rich lipoprotein (TRL) levels.
Plozasiran has been developed by Arrowhead Pharmaceuticals Inc. with the potential to treat hypertriglyceridaemia. It works as an RNA interference drug by blocking the creation of a protein called Apolipoprotein C3 (ApoC3). People with 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 hypertriglyceridaemia. Approximately 1328 eligible patients globally will be randomised in a 3:1 ratio to receive subcutaneous (SC) 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 70 weeks (6 weeks screening period, 12months treatment period and 3 months follow-up).
The study is sponsored by Arrowhead Pharmaceuticals, Inc.REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0526
Date of REC Opinion
21 Aug 2024
REC opinion
Further Information Favourable Opinion