Phase IIa

A Phase II, multi­center, double blind, randomized, placebo controlled study on the effect of Aramchol™ on liver triglyc­erides concen­tration in patients with steatosis due to NAFLD or NASH

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.)

Chart of study. Explained in text below

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

Relative percent changes MRS: Aramchol™ 300mg given to 20 subjects change of minus 12.57 percent.Aramchol™ 100mg given to 18 subjects change of minus 2.89 percent. Placebo given to 19 subjects change of 6.39 percent.

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)

Patients in each category with adverse events: 9. Aramchol™ 300m: One with abdominal pain and two with upper respiratory tract infection. Aramchol™ 100mg One with abdominal pain and two with abdominal upper pain. Placebo two with bdominal pain, one with abdominal upper pain, three with back pain, 2 with constipation and two with Asthenia.

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.

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