4492: Semaglutide in patients with NASH Cirrhosis (F4)

  • Research type

    Research Study

  • Full title

    Investigation of efficacy and safety of semaglutide s.c. once-weekly versus placebo in subjects with non-alcoholic steatohepatitis and compensated liver cirrhosis

  • IRAS ID

    260061

  • Contact name

    Philip Newsome

  • Contact email

    p.n.newsome@bham.ac.uk

  • Sponsor organisation

    Novo Nordisk Ltd

  • Eudract number

    2018-004484-31

  • Clinicaltrials.gov Identifier

    U1111-1224-4062 , Universal Trial Number (UTN)

  • Duration of Study in the UK

    1 years, 7 months, 29 days

  • Research summary

    Non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH) represents a growing disease in Western countries. The prevalence of NASH is estimated to be in the region of 3 to 5% of the Western population. Around 10% of people with NASH develop cirrhosis (advanced liver disease), which means the normal liver cells are replaced by scar tissue (also known as fibrosis) and the liver function declines. Today cirrhosis caused by NASH is the third most common cause of liver transplantation in USA and is expected to be the primary cause in 2020.

    The reason that the liver develops cirrhosis in NASH is not well understood, but excess weight/obesity, and type 2 diabetes mellitus are thought to be key factors in the causation of NASH.

    Patients with NASH and cirrhosis have the highest mortality rate when compared to patients with NASH and less scar tissue. Cirrhosis can potentially be reversed with effective therapy. Currently, first-line treatment of NASH in patients with liver cirrhosis and overweight is lifestyle interventions to provide weight loss and to treat associated diseases (e.g. high amounts of lipids in the blood, chronic high blood pressure and diabetes) as no specific medicines are approved. In the case of progression to end-stage liver disease, liver transplantation is the only treatment option.

    Therefore, there is a substantial unmet medical need for effective treatment in patients with NASH and liver cirrhosis.

    NN9931-4492 is a randomised, double-blind, placebo-controlled, parallel group, multi-centre study investigating the efficacy and safety of 2.4mg subcutaneous (s.c.) semaglutide once weekly versus placebo in subjects with NASH and liver cirrhosis.

    The study duration is approximately 61 weeks, consisting of a screening period of 6 weeks, 48 week treatment period and 7 week follow up period. If eligible, subjects will be randomised in a 2:1 manner to semaglutide s.c. 2.4mg or corresponding volume of placebo.

  • REC name

    East of England - Cambridge South Research Ethics Committee

  • REC reference

    19/EE/0124

  • Date of REC Opinion

    13 May 2019

  • REC opinion

    Further Information Favourable Opinion