A Phase 2b Randomized Double Blind Placebo-Controlled Multicenter Study Evaluating Safety and Efficacy of EDP-305 in Subjects with Liver Biopsy Proven Non- Alcoholic Steatohepatitis (NASH) (ARGON-2)

Brief description of study

The purpose of this study is to compare the effects of the EDP-305 with placebo to see which treatment is better or is safer than having no treatment. In this document, the term ‘Study Drug’ will be used to refer generally to EDP305 and placebo, since both of these are being used in this study. A placebo looks like EDP-305 but does not contain any active drug. The study will also measure how safe EDP-305 is for treating people with NASH, including the concentration (amount) of EDP-305 in your blood at various times. EDP-305 increases the activity of a biological system inside liver cells called the farnesoid X-receptor (FXR). FXR regulates bile acid production by the liver and intestine. The main function of bile acids is to allow digestion of dietary fats and oils. They also have hormonal actions throughout the body, particularly through the FXR. Bile acids are therefore important in controlling fat absorption in the body. By increasing the activity of FXR, EDP-305 may reduce the inflammation, the fibrosis (scar tissue) and the buildup of fat in the liver that occurs in people with NASH. The Study Drug EDP-305 is considered an investigational drug in this study because it has not been approved by the Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States.

Clinical Study Identifier: s19-01330
ClinicalTrials.gov Identifier: NCT04378010

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