A Phase IIb, double blind randomized, controlled clinical trial, to evaluate the efficacy and safety of two Aramchol doses versus placebo in patients with Non-Alcoholic Steatohepatitis (NASH)
ID Number 15-2045Principal Investigator(s)
Department(s) or Division(s)
The purpose of this study is to test a new investigational drug called Aramchol. The study will be a multinational, multicenter trial to compare the efficacy, tolerability and safety of Aramchol tablets 400 mg and 600 mg to placebo tablets, in 240 NASH subjects who also suffer from obesity and Diabetes Mellitus type II or pre-diabetes.
Subjects may qualify to take part in this research study because they have NASH and also suffer from obesity and Diabetes Mellitus type II or pre-diabetes.
Subject participation in this research study is expected to last 69 weeks. This study is scheduled to have a screening period of up to 4 weeks and will be followed by 52 weeks of dosing with Aramchol 400 mg, 600mg or placebo. A follow up period of 13 weeks after end of treatment period will be conducted without study drug.
Subjects who will be randomized to the 400 mg group will be treated with one tablet of 400 mg Aramchol and one tablet of placebo. In the 600 mg group subjects will be treated with one tablet of 400 mg and one tablet of 200 mg Aramchol. Those who will be randomized to the placebo group will receive two tablets of placebo.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is approximately 240.
Recruiting Patients: Yes