skip to Main Content

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

Treatment Plane

Once-daily tablet for 12 months and 3 months follow-up

Primary End­point

% 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 thank 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 Clin​i​cal​Trials​.gov (iden­tifier: NCT02279524); this study is ongoing but not recruiting par­tic­i­pants; results are expected Q2 2018

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 most effective 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.
Back To Top