SHP626-201 Volixibat in Adults with Nonalcoholic Steatohepatitis

• Research type

  Research Study

• Full title

  A Phase 2 Double-Blind, Randomized, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi) in Adults with Nonalcoholic Steatohepatitis (NASH)

• IRAS ID

  206701

• Contact name

  Guruprasad Aithal

• Contact email

  guru.aithal@nuh.nhs.uk

• Sponsor organisation

  Shire Human Genetic Therapies, Inc.

• Eudract number

  2016-000203-82

• Duration of Study in the UK

  2 years, 8 months, 17 days

• Research summary

  This is a Phase 2 Double-Blind, Randomized, Placebo-controlled, Dose-finding
  Study to Evaluate the Safety, Tolerability and Efficacy of Volixibat Potassium in Adults with Nonalcoholic Steatohepatitis (NASH). 266 people, aged 18 through 80, in about 60 to 80 sites in the United States, Canada, and the United Kingdom are expected to take part in this study.

  Suitable participants will be randomised into one of four dose groups (5mg, 10mg, 20mg or placebo) and be given study treatment in the form of a capsule once a day.

  The study will last for about 60 weeks and participants will be expected to attend 10 site visits during this time. The following are some of the study procedures that will be performed during study visits: completion of study questionnaires, blood samples, urine tests, MRI scans and liver biopsy if required.

• REC name

  South Central - Hampshire B Research Ethics Committee

• REC reference

  16/SC/0454

• Date of REC Opinion

  9 Nov 2016

• REC opinion

  Further Information Favourable Opinion