SIMPLE
Research type
Research Study
Full title
Assessing the impact of PCSK9 inhibitors in steatotic liver disease: a prospective observational cohort study
IRAS ID
343787
Contact name
Jacob George
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
1 years, 8 months, 2 days
Research summary
Steatotic liver disease [SLD], characterised by an excess of fat in the liver, is an emerging global health challenge. Over time excess liver fat in SLD can lead to liver scarring (cirrhosis) and liver cancer in a minority of people. Treatment options in SLD are limited but multiple studies have shown some existing drugs, used in other health conditions, may help treat SLD.
Proprotein convertase subtilisin/kexin type-9 inhibitors [PCSK9i] are medications used to treat high cholesterol. Some studies have shown PCSK9i may reduce liver fat in SLD. However, these studies have only been in small numbers of people, using inaccurate tests.
The SIMPLE study aims to measure the effect of PCSK9i, being prescribed to patients as part of their routine care, on liver fat, measured using transient elastography (Fibroscan) and non-invasive markers of liver fat and fibrosis (scarring), after 9 months of PCSK9i treatment.
REC name
West of Scotland REC 5
REC reference
24/WS/0145
Date of REC Opinion
9 Oct 2024
REC opinion
Further Information Favourable Opinion