4296: NASH-Semaglutide in subjects with non-alcoholic steatohepatitis
Research type
Research Study
Full title
Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis. A 72-week randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre, multinational trial
IRAS ID
212830
Contact name
Philip Newsome
Contact email
Sponsor organisation
Novo Nordisk Ltd
Eudract number
2016-000685-39
Clinicaltrials.gov Identifier
U1111-1179-7464, Unique Trial Number (UTN)
Duration of Study in the UK
2 years, 7 months, 12 days
Research summary
Non-alcoholic steatohepatitis is one of the common liver diseases in the UK and is predicted to become the leading indication for liver transplantation. However, there are currently no licensed therapies for this condition meaning there is a major unmet clinical need.
A recent study published in the Lancet indicated that a drug called Liraglutide was effective in reducing the liver damage seen in patients with non-alcoholic steatohepatitis. This is a larger follow-on study with a more effective version of Liraglutide known as Semaglutide. This study, sponsored by the pharmaceutical company Novo Nordisk, will test whether Semaglutide is effective in reducing liver damage in patients with non-alcoholic steatohepatitis.
NN9931-4296 is a randomised, double-blind, placebo-controlled, six-armed parallel group, multi-centre, multinational study investigating the efficacy and safety of three dose levels of subcutaneous (s.c.) Semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis.
Patients with non-alcoholic steatohepatitis and evidence of liver scarring on liver biopsy will be eligible for this study.
The study duration is approximately 85 weeks, consisting of a screening period of 6 weeks, 72 week treatment period and 7 week follow up period. If eligible, subjects will be randomised in a 3:3:3:1:1:1 manner to receive daily dosing of Semaglutide s.c. 0.1mg, 0.2mg, 0.4mg or corresponding injection volumes of placebo once daily. There will be a dose escalation period in the study. All patients will have a starting dose of 0.05mg, with dose escalation every 4th week until their randomisation dose is reached.
The study consists of 14 hospital clinic visits and 5 phone contacts. The patients will be required to have up to 2 liver biopsies during the study. The study plan is to include a total of 372 randomised subjects across 15 countries including the UK. The planned number of UK randomised subjects is 45 across 12 sites.
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/1709
Date of REC Opinion
13 Oct 2016
REC opinion
Favourable Opinion