A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)

Phase 3 Suspended NCT04104321

Summary

An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups according to the post-baseline biopsy. The objective of the Open-Label Part is: * To evaluate the safety and PK of twice daily administration (BID) of Aramchol 300mg in subjects with NASH and liver fibrosis. * To explore the kinetics of histological outcome measures and Non-Invasive Tests (NITs) associated with NASH and fibrosis for the treatment duration of 24, 48 and 72 weeks. All patients will be allocated to Aramchol. Double Blind Part: This part is double blind, placebo controlled randomized in subjects with NASH and fibrosis stages 2-3 who are overweight or obese and have prediabetes or type 2 diabetes. The primary objectives of this part of the study are to evaluate the effect of Aramchol as compared to placebo on NASH resolution, fibrosis improvement and clinical outcomes related to progression of liver disease. Subjects will be randomized to receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio. This double-blind phase of the stu

Open Label Part: Improvement of Fibrosis Based on Liver Biopsy

Up to 72 or 120 weeks · percentage of participants improving

Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Liver Histology by Assessing the Following Primary Endpoints. Study Was Suspended and Thus Results Are Expected 2027

72 weeks

Double Blind Part: To Evaluate the Effect of Aramchol Compared to Placebo on Composite Long-term Outcome Study Was Suspended so Results Expected 2027

at End of Study, latest at 5 years from last subject's randomization

Open in BENITIONS View on ClinicalTrials.gov

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