NCT02927314

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Can-Fite BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Non-alcoholic Steatohepatitis (NASH)

Interventions

Type	Name	Description
DRUG	CF102	orally q12h
DRUG	Placebo	orally q12h

Timeline

• Start date: 2017-11-27
• Primary completion: 2020-03-01
• Completion: 2020-03-01
• First posted: 2016-10-07
• Last updated: 2020-03-17

Locations

3 sites across 1 country: Israel