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Phase IIb

ARamachol for REsolution of STeatohepatitis (ARREST)

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)

Study Arms

400mg; 600mg; Placebo (2:2:1)

Treatment Plane

Once‐​daily tablet for 12 months and 3 months follow‐​up

Primary Endpoint

Percent change in the liver triglyc­erides concen­tration measured by MRS

No. of Subjects


Secondary Endpoint

Proportion in percentages of subjects with CRN Fribrosis Score Improvement without worsening of NASH

Proportion in percentages of subjects with NAS score improvement — less than two points — without worsening of CRN Fibrosis Score

Proportion in percentages of subjects with NASH Resolution — ballooning 0; inflam­mation 0 or 1 — without worsening of CRN Fibrosis Score

More infor­mation about the ARREST study may be found on ClinicalTrials​.gov (identifier: NCT02279524); this study has been completed

Global Distribution and Baseline Histology of Randomized Patients

The ARREST study is being conducted in 80 centers in 12 countries. Approximately 1/​3 of the patients are from the USA, 1/​3 from Europe and 1/​3 from RoW.

Four Continents, 12 Countries, 80 Centers

ARREST enrolled a population with advanced NASH with fibrosis enabling the design of the pivotal Phase III study with a single dose and optimized primary endpoint. Patients enrolled into the ARREST study showed advanced disease, 60% having stage 2 and 3 fibrosis at baseline and 70% with NAS>5.

Pie chart One: 70 percent of patients have NAS greater than 5. Pie chart Two: 60 percent of patients have fibrosis stage 2 and 3.
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