Investigation of BI 1467335 versus placebo in patients with NASH.
Research type
Research Study
Full title
A multi-centre, double-blind, parallel-group, randomised, placebo controlled phase II a study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of different doses of orally administered BI 1467335 during a 12-week treatment period compared to placebo in patients with clinical evidence of NASH.
IRAS ID
220963
Contact name
Philip Newsome
Contact email
Sponsor organisation
Boehringer-Ingelheim
Eudract number
2016-000499-83
Duration of Study in the UK
1 years, 4 months, 1 days
Research summary
This study is a multi-centre, double-blind, parallel-group, randomised, placebo controlled phase II a study to investigate safety, tolerability, pharmacodynamics, and pharmacokinetics of different doses of orally administered BI 1467335 during a 12-week treatment period compared to placebo in patients with clinical evidence of non-alcoholic-steato-hepatitis (NASH). The population will include male and female patients over 18 years of age with clinical evidence for NASH and ALT > 1.5 upper limit normal. Patients with a history of significant alcohol consumption or other forms of chronic liver disease (including liver cirrhosis) will be excluded. 147 patients are planned to be randomised in this trial. All eligible patients will be instructed at every visit (including screening) to adhere to their normal dietary and exercise regimen from screening until safety follow-up visit. Eligible patients will be randomised to the 12 week double-blind treatment period at Visit 2 and will be assigned to one of the 5 treatment groups (placebo QD, BI 1467335 1 mg QD, BI 1467335 3 mg QD, BI 1467335 6 mg QD or BI 1467335 10 mg QD; each patient will receive one active treatment and/or placebos to match the alternative active treatment).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0237
Date of REC Opinion
14 Aug 2017
REC opinion
Further Information Favourable Opinion