ARamachol™ for REsolution of STeatohepatitis (ARREST)
400mg; 600mg; Placebo (2:2:1)
Once-daily tablet for 12 months and 3 months follow-up
Percent change in the liver triglycerides concentration measured by MRS
No. of Subjects
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
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.
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.