A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease

Non-alcoholic Steatohepatitis (NASH) Clinical Trial

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH)

Status Completed

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled clinical trial in subjects with NAFLD and NASH.

Clinical Trial Description

This is a multicenter, randomized, double-blind, placebo-controlled study in subjects with a diagnosis of NAFLD. Subjects will undergo Screening procedures during the 4 weeks preceding Baseline. Subjects will be randomly assigned in a 1:1:1 ratio to oral doses of CF102 12.5 mg BID, CF102 25 mg BID, or matching placebo BID for 12 weeks using a stratified randomization, with stratification by presence or absence of diabetes mellitus. Subjects will be evaluated regularly for safety, and indicators of efficacy will be measured at Baseline and Week 12. Subjects will return for a follow-up visit 4 weeks after completion of the last dose of study drug. ;

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Non-alcoholic Steatohepatitis (NASH)

• NCT number: NCT02927314
• Study type: Interventional
• Source: Can-Fite BioPharma
• Status: Completed
• Phase: Phase 2
• Start date: November 27, 2017
• Completion date: March 1, 2020