FENOFIBRATE FOR TREATMENT OF NASH: A RANDOM, DOUBLE BLIND, PLACEBO-CTRLD STUDY

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Non-alcoholic steatohepatitis (NASH) is characterized by fatty infiltration of the liver accompanied by inflammation which can progress to varying degrees of fibrosis and cirrhosis. There is currently no known treatment for NASH, though several studies are being currently conducted. There is evidence that insulin resistance is a key factor in the pathogenesis of fatty liver in NASH. We hypothesize that the use of fenofibrate improves insulin resistance, decreases liver fat, and improves the histologic severity of NASH. We hope to asses the effect of fenofibrate on the histologic improvement of NASH and to assess the safety of fenofibrate in patients with NASH. We plan to conduct a double-blind, placebo controlled study where the subject will undergo a one-year treatment with the study medication (fenofibrate or placebo) with histologic evaluation of the liver before treatment and at the end of 48 weeks of therapy in the study in order to assess histologic improvement. Other tests will include whole fat oxidation using indirect calorimetry study, glucose tolerance, and a DEXA scan to assess abdominal fat before and following fenofibrate treatment. During treatment, patients will be evaluated every one to two months by interview and blood draw as indicated in the protocol. The study will include all genders and races; subjects with child bearing potential will receive pregnancy screening. Recruitment will be on a first come-first serve basis. Research records will be coded and kept in a locked file cabinet, data acquired from the subjects will only be linkable by the investigators.'