Galmed, NASH

Galmed, NASH

Title: A Phase 3/4 Clinical Study to Evaluate the Efficacy and Safety of Aramchol Versus Placebo in Subjects With NASH (ARMOR) (ARMOR)

Associated condition: NASH

Status: Currently enrolling

Brief summary: Also known as the ARMOR Study, this is a double-blind placebo controlled randomized Phase 3/4 study in overweight or obese subjects with nonalcoholic steatohepatitis (NASH) and fibrosis stages 2-3 who have prediabetes or type 2 diabetes. Subjects will receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio.

Primary objectives: To evaluate Aramchol’s effect as compared to placebo on the resolution of NASH resolution, fibrosis improvement and clinical outcomes associated with the progression of liver disease.

Estimated length of study: Maximum of 5 years from last subject’s randomization; estimated study completion of December 2024.

For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.

Submit Your Information for Consideration

HIPAA COMPLIANT FORM

Title: A Phase 3/4 Clinical Study to Evaluate the Efficacy and Safety of Aramchol Versus Placebo in Subjects With NASH (ARMOR) (ARMOR)

Associated condition: NASH

Status: Currently enrolling

Brief summary: Also known as the ARMOR Study, this is a double-blind placebo controlled randomized Phase 3/4 study in overweight or obese subjects with nonalcoholic steatohepatitis (NASH) and fibrosis stages 2-3 who have prediabetes or type 2 diabetes. Subjects will receive Aramchol 300mg BID or matching placebo in a 2:1 randomization ratio.

Primary objectives: To evaluate Aramchol’s effect as compared to placebo on the resolution of NASH resolution, fibrosis improvement and clinical outcomes associated with the progression of liver disease.

Estimated length of study: Maximum of 5 years from last subject’s randomization; estimated study completion of December 2024.

For more detailed information on this research trial, including eligibility and study design, please visit the clinical trial page at U.S. National Library of Medicine’s website. Note you can submit your information for consideration by submitting the contact form on this page.

Submit Your Information for Consideration