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

No. of Subjects

N=247

Primary Endpoint

  • Percent change in the liver triglyc­erides concen­tration measured by MRS

Secondary Endpoint

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

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

Phase IIb Data for Galmed Pharmaceutical’s Aramchol™ in Non-​Alcoholic Steatohepatitis (NASH) PDF icon

These results were presented during a Late Breaking Abstract Oral Session at The Liver Meeting® 2018 during the American Association for the Study of Liver Diseases (AASLD).

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