The ARMOR Study

In a multinational, placebo-controlled, Phase 2b ARREST study involving treatment for 52 weeks in 247 patients with NASH, Aramchol™ significantly reduced liver fat, improved liver histology, hepatic biochemistry and glycemic parameters with a favorable safety and tolerability profile.

https://clinicaltrials.gov/ct2/show/NCT02279524

ARMOR is a double-Blind, Placebo-Controlled registrational Ph3 study testing whether an investigational medicine Aramchol™ is effective and safe for the treatment of NASH and fibrosis. The study has been initiated internationally early 2020 however due to the COVID-19 outbreak, an Open-Label Part was added to the ARMOR study to enable the existing study resources to be used efficiently during the COVID-19 pandemic, while enrollment in the Double-Blind, Placebo-Controlled Part is pending. 

The Open-Label Part includes 150 subjects with NASH and liver fibrosis stage 1-3, who may or may not be overweight, and subjects with NASH who may or may not have Type 2 Diabetes Mellitus (T2DM) or be pre-diabetic. The Open-Label Part will provide important safety and PK data as well as obtain important data to help characterize the kinetics of histological outcomes of Aramchol™ and Non-Invasive Tests (NITs) for NASH associated with liver fibrosis after several time points (i.e., 24, 48 and 72 weeks). The Open-Label Part will continue for the same duration as the Randomized, Double-Blind, Placebo-Controlled Part once resumed.

In order to qualify for the study, you need to be 18 years or older and suffer from NASH with liver fibrosis. You will be evaluated for NASH using non-invasive methods and if found eligible, you will undergo a liver biopsy.

Once you have qualified for the study, you will be assigned either to a group that will receive Aramchol™ treatment or to a group that will receive a placebo (a pill that has no medical effect). You are twice as likely to receive Aramchol™ as the placebo in this study. During the study, your health will be followed closely for several years, through routine scheduled visits with your study doctor. 

If you qualify and join the study, you may receive reimbursement for time and travel and the study drug will be provided at no cost to you. 

Further information about the ARMOR Study can be found on ClinicalTrials.gov identifier: NCT04104321

https://www.clinicaltrials.gov/ct2/show/NCT04104321?term=04104321&draw=2&rank=1