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The ARMOR Study


Title A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH) (The ARMOR Study)
Therapeutic Area Fatty Liver
Principal Investigator Raza Malik, MD, PhD
Min Age 18 Years
Max Age 75 Years
Gender All
Contact Christina Picornell
617-636-0653
cpicornell@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04104321

Overview

This study evaluates the efficacy and safety of the investigational treatment Aramchol as compared to placebo in subjects with Nonalcoholic Steatohepatitis (also known as NASH or Fatty Liver)

Study Details

Inclusion Criteria

  • Diagnosis of NASH (Fatty Liver)
  • Diabetes Type II or Prediabetes
  • Liver Fibrosis Stage must be 2 or 3

Exclusion Criteria

  • Diagnosis of liver cirrhosis
  • Inability or unwillingness to undergo a liver biopsy
  • Abnormal synthetic liver function

Study Requirements

This study will consist of an 8 week screening period. During this period you will need to have the following screening tests to make sure you are eligible to participate: a physical exam, ECG, Elastography (Fibroscan), Liver biopsy, as well as provide blood and urine samples. During the treatment period, there will be study visits at baseline, weeks 4, 8, 12, 36, 52 and every 4 months thereafter. During these visits you will also receive a physical exam and blood/urine samples will be collected to monitor your health. Follow-up liver biopsies and Fibroscans will also be required: Liver biopsies at week 52 and the 5 year mark, Fibroscan at week 84 and every 8 months thereafter. During the treatment period, you will be assigned to take either, 300mg of Aramchol or placebo, twice daily.