Phase IIa
Study Arms
300mg; 100mg; Placebo
Primary Endpoint
Percent change in liver triglycerides concentration measured by MRS
No. of subjects
N=60
Treatment Plane
Once‐daily tablet for 12 weeks and 4 weeks follow up
Secondary Endpoint
Liver and metabolic biomarkers level
More information about the Phase IIa study may be found on ClinicalTrials.gov (indentifier:NCT01094158); this study has been completed.)

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

Safadi R, Konikoff FM, et al. “The fatty acid–bile acid conjugate aramchol reduces liver fat content in patients with nonalcoholic fatty liver disease.” Clinical Gastroenterology and Hepatology 12.12 (2014): 2085–2091.
Adverse Events: the Overall and the Most Frequent Events (>2 Patients in Any Group)

Safadi R, Konikoff FM, et al. “The fatty acid–bile acid conjugate aramchol reduces liver fat content in patients with nonalcoholic fatty liver disease.” Clinical Gastroenterology and Hepatology 12.12 (2014): 2085–2091.