A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
Status:
Completed
Trial end date:
2018-05-22
Target enrollment:
Participant gender:
Summary
This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed
to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years
of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a
period of 6 months before entering the study, with overweight or obesity and who are pre
diabetic or type II diabetic.
Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg
tablets and placebo tablets in ratio 2:2:1.
The subjects will be evaluated at study sites for 11 scheduled visits during one year (52
weeks). After completion of the study treatment period, the subjects will be followed for an
additional period of 13 weeks without study medication (until visit 11 (week 65)).
Phase:
Phase 2
Details
Lead Sponsor:
Galmed Pharmaceuticals Ltd Galmed Research and Development, Ltd.
Collaborators:
Clinical Reference Laboratory ClinIntel Diamond Pharma Services Diamond Pharma Services Regulatory Affairs Consultancy DSG EDC Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico Itamar-Medical, Israel Medical University of Graz One Way Liver OWL Sharp Clinical Services Tel-Aviv Sourasky Medical Center TransPerfect