Can-Fite BioPharma submits protocol for Phase II trial of NAFLD/NASH candidate
Can-Fite BioPharma has submitted the clinical trial protocol for its Phase II study of CF102 in the treatment of non-alcoholic fatty liver disease, the precursor to non-alcoholic steatohepatitis, to an Institutional Review Board in Israel. Based on the protocol that was submitted, Can-Fite's Phase II study will be a multicenter, randomized, double-blinded, placebo-controlled, dose-finding study of the efficacy and safety of CF102 in the treatment of NAFLD/NASH. The study will enroll approximately 60 patients with NAFLD, with or without NASH, and will have three arms. The study's primary endpoints will be percent change from baseline in liver triglyceride concentration measured by nuclear magnetic resonance spectroscopy and safety.