4553 ESSENCE - Semaglutide in NASH
Research type
Research Study
Full title
The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis
IRAS ID
292074
Contact name
Matthew Armstrong
Contact email
Eudract number
2019-004594-44
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Universal Trial Number, U1111-1244-3678
Duration of Study in the UK
7 years, 1 months, 26 days
Research summary
Non-alcoholic steatohepatitis (NASH) is associated with increased risk of morbidity and mortality. Currently, treatment options are few and insufficient. There is therefore an unmet medical need for effective and safe pharmacological treatments options.
Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), can address metabolic and histological aspects of NASH and is therefore considered a strong candidate for the treatment of NASH.
The trial has two parts, part 1 and part 2, with distinctive objectives and endpoints. In part 1, the primary hypothesis is that semaglutide improves liver histology in patients with NASH and fibrosis stage 2 or 3. In part 2, the primary hypothesis is that semaglutide lowers the risk of liver-related clinical events.
The secondary hypothesis is that Semaglutide lowers body weight, has an effect on cardio-metabolic factors and patient-reported outcomes and an effect on biomarkers related to fibrosis.Subjects will be randomised 2:1 to receive treatment with semaglutide s.c. or placebo.
The study will be carried out at secondary care sites and will last approx 4 years and 11 months.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/1291
Date of REC Opinion
12 Feb 2021
REC opinion
Further Information Favourable Opinion