Safety, tolerability, PK & efficacy of LMB763 in patients with NASH

• Research type

  Research Study

• Full title

  A randomized, patient and investigator blinded, placebo-controlled, multicenter study to assess the safety, tolerability, pharmacokinetics and efficacy of LMB763 in patients with non-alcoholic steatohepatitis (NASH)

• IRAS ID

  207351

• Contact name

  Richard Aspinall

• Contact email

  richard.aspinall@porthosp.nhs.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2016-002833-31

• Clinicaltrials.gov Identifier

  NCT02913105

• Duration of Study in the UK

  1 years, 3 months, 1 days

• Research summary

  Clinical research study to find out if the drug, LMB763, is safe and has beneficial effects in people who have non-alcoholic steatohepatitis (NASH). NASH is a condition that results in liver inflammation and damage due to a build up of fat in the liver.
  The main purpose of the study is to investigate whether the drug LMB763 is safe in patients with NASH, and whether it improves the level of alanine aminotransferase (ALT) in the blood which is a test used to detect liver injury. This study compares the effects of LMB763 with a placebo.
  Study participation will last for about six months, e.g. up to approximately 172 days, including the screening, baseline, treatment period and end of study assessments.
  The United Kingdom is looking for 20 patients from 3 sites.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  16/EE/0552

• Date of REC Opinion

  17 Feb 2017

• REC opinion

  Further Information Favourable Opinion