300mg; 100mg; Placebo
Percent change in liver triglycerides concentration measured by MRS
No. of subjects
Once-daily tablet for 12 weeks and 4 weeks follow up
Liver and metabolic biomarkers level
In this trial, Aramchol™ was found to be safe and tolerable, with statistically significant reduction of liver fat content in patients with NAFLD. The reduction in liver fat content occurred in a dose-dependent manner and was associated with a trend of metabolic improvements, indicating that Aramchol™ might be used for the treatment of fatty liver disease.
Importantly, results of the Phase IIa study showed translation from animal data to humans using the relevant doses, establishing Aramchol™ 300mg as the minimal effective dose.
Percent relative change in liver TG levels, baseline and end of treatment
Adverse Events: the Overall and the Most Frequent Events (>2 Patients in Any Group)