Phase 2 - GS-9674 in patients with NASH

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, tolerability, and Efficacy of GS-9674 in Subjects with Nonalcoholic Steatohepatitis (NASH)

• IRAS ID

  215647

• Contact name

  Michael Allison

• Contact email

  michael.allison@addenbrookes.nhs.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2016-002496-10

• Clinicaltrials.gov Identifier

  NCT02854605

• Clinicaltrials.gov Identifier

  127960, IND Reference Number

• Duration of Study in the UK

  0 years, 7 months, 1 days

• Research summary

  This is a Phase 2, randomised, double-blind, placebo-controlled study investigating the treatment of Non-alcoholic Steatohepatitis (NASH). NASH is an inflammatory disease of the liver caused by build-up of fat. The body’s immune system may respond to the fat by attacking and damaging the liver cells, forming scar tissue where healthy cells used to be. This scar tissue may eventually lead to permanent liver damage (cirrhosis). A cirrhotic liver is at risk of failing. There are currently no approved therapies for NASH although an estimated 15 million people suffer from this disease in the United States alone. The purpose of this study is to see if GS-9674 (the study medication) is effective, well-tolerated and safe in treating people with NASH.

  Approximately 125 participants with NASH will be enrolled, aged 18 to 75, at around 50 centres in North America, Europe and Asia Pacific.

  Once screening has occurred, the study comprises of the Treatment Phase (24 weeks) and the Follow-Up (4 weeks). During the Treatment Phase, participants will be randomly assigned, in a ratio of 2:2:1, to one of the three following treatment groups:
  • Group A: GS-9674 30mg + placebo 100mg daily
  • Group B: GS-9674 100mg + placebo 30mg daily
  • Group C: placebo 30mg + placebo 100mg daily

  Eligible participants will visit the clinic at least 8 times over the Treatment Phase and once more for the Follow-Up. They will undergo various study procedures to assess the safety and effectiveness of GS-9674.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  17/WM/0021

• Date of REC Opinion

  24 Feb 2017

• REC opinion

  Further Information Favourable Opinion