5% on Day 14 and by 14.1% on Day 28 (both p<0.05 vs Day 1). The

most frequently reported treatment emergent adverse events were mild gastrointestinal AEs that were most likely related to the mechanism of action of LUM002. No clinically significant changes in liver enzymes or fat absorption parameters were observed. CONCLUSIONS: LUM002 dosed at 10 mg/day in T2DM patients was safe and tolerable for 28 days of treatment and had a positive effect on lipid and glucose metabolism, supporting Vismodegib in vitro the possible utility of LUM002 for the treatment of patients with NASH. Disclosures: Renger Tiessen – Employment: PRA health sciences; Grant/Research Support: Lumena Ciara Kennedy – Employment: Lumena Pharmaceuticals Bradley T. Keller – Consulting: Shire Human Genetic Therapies Inc; Employment: Lumena Pharmaceuticals, Rivervest Venture Partners Nancy Levin – Consulting: Lumena Pharmaceuticals Dee Wynne – Employment: lumenapharmaceuticals Bronislava Gedulin – Employment: Lumena Pharmaceuticals Elizabeth Olek – Consulting: Lumena Pharmaceuticals, Inc Alejandro Dorenbaum – Employment: Lumena Pharmaceutical, Stanford University; Stock Shareholder: BioMarin Pharmaceutical The following people have nothing to disclose: Lisette Acevedo, Andre A. van Vliet Background & Aims: Apolipoprotein (apo) A-V, a minor plasma apolipoprotein, has been implicated in liver fat storage and mobilization, and therefore may be involved in the

patho-genesis of the metabolic syndrome. Non-alcoholic fatty liver disease (NAFLD) is the hepatic manifestation of MCE the metabolic syndrome, with non-alcoholic steatohepatitis

(NASH) being its severe form exhibiting liver inflammation. ApoA-V is expressed Lorlatinib clinical trial only in the liver. The current study is designed to test our hypothesis that apoA-V plays a role in the pathogenesis of NASH. Methods: The study was approved by the Institutional Review Board of SUNY Buffalo. Patients were diagnosed with NASH on liver biopsy according to Kleiner’s criteria. Hepatic gene expression for apoA-V and other related genes was accessed by microarray analysis and quantitative real-time PCR. Spearman’s coefficient analyses were performed to examine possible correlations of apoA-V expression to the grade of steatosis, and to the expression levels of other NASH related liver genes. Results: Our NASH microarray data showed increased gene expression of apoA-V in NASH livers compared to normal controls (NC) (NASH/NC=3.8, p =0.004). Similar results were observed with a different patient cohort by qRT-PCR (NASH/ NC=5.9, p=0.000). The expression levels of apoB and MTP were also elevated in NASH livers and positively correlated with that of apoA-V. Among NASH patients, liver ApoA-V expression was negatively correlated to grade of steastosis (r= -0.80, P<0.01). ApoA-V expression was also negative correlated to blood TG (r= -0.63, P<0.05), VLDL (r= -0.63, P<0.05); and positively correlated to serum ALT (r=0.73, P<0.01), AST (r=0.67, P<0.