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Nonalcoholic fatty liver disease (NAFLD), including its severe form known as steatohepatitis or NASH, are increasingly common in patients with type 2 diabetes mellitus (T2DM) and can progress to cirrhosis. However, there is limited information on their comorbid medical conditions in “real world” practice. Thus, the disease characteristics of patients with NASH or NASH-cirrhosis (cirrhosis), with or without T2DM, was evaluated in TARGET-NASH, an ongoing longitudinal observational study of patients with NAFLD, who are managed according to local standards at 60 community and academic hepatology and endocrinology practices in the United States. Among 3085 patients enrolled with NASH or cirrhosis, 1645 had NASH (47% T2DM) and 1440 had cirrhosis (72% T2DM). Patients with T2DM were older (median 61 vs. 56 years) and had a higher median BMI (34.0 vs. 32.0 kg/m2, p In conclusion, patients with type 2 diabetes and NASH or cirrhosis had more advanced liver disease compared to those without type 2 diabetes. Patients with type 2 diabetes had more than twice the risk of cirrhosis compared to those without type 2 diabetes. These results support a strong link of type 2 diabetes and metabolic risk factors with advanced NASH. Disclosure K. Cusi: Consultant; Self; Allergan plc., AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., Gilead Sciences, Inc., Merck & Co., Inc. Research Support; Self; Cirius Therapeutics, Echosens, Eli Lilly and Company, Inventiva Pharma, Janssen Pharmaceuticals, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Poxel SA, Zydus Pharmaceuticals, Inc. M. Roden: Advisory Panel; Self; Servier. Board Member; Self; Poxel SA. Consultant; Self; Eli Lilly and Company, Gilead Sciences, Inc., ProSciento, TARGET PharmaSolutions. Research Support; Self; Boehringer Ingelheim International GmbH, Novartis Pharma K.K., Sanofi US. Speaker’s Bureau; Self; Novo Nordisk A/S. A.S. Barritt: Consultant; Self; GENFIT, Intercept Pharmaceuticals, Inc., TARGET PharmaSolutions. R.J. Firpi: None. V. Clark: Research Support; Self; GENFIT, Intercept Pharmaceuticals, Inc., Novo Nordisk Inc. S. Klein: Advisory Panel; Self; Danone Nutricia, Merck & Co., Inc. Research Support; Self; Johnson & Johnson, Pfizer Inc. Stock/Shareholder; Self; Aspire Bariatrics. A. Lok: None. P. Newsome: Research Support; Self; Novo Nordisk A/S. K. Corbin: None. M.B. Vos: Advisory Panel; Self; TARGET PharmaSolutions. Consultant; Self; Boehringer Ingelheim (Canada) Ltd., Immuron, Intercept Pharmaceuticals, Inc., Mallinckrodt Pharmaceuticals, Novo Nordisk A/S. Research Support; Self; Bristol Myers Squibb. R. Reddy: Advisory Panel; Self; Ambys, Epigenomics AG, Mallinckrodt Pharmaceuticals, Merck & Co., Inc. Research Support; Self; Conatus Pharmaceuticals, Exact Sciences, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Mallinckrodt Pharmaceuticals, Merck & Co., Inc. C. Schoen: None. A.R. Mospan: Employee; Self; TARGET PharmaSolutions. J.L. Taunk: None. K. Wyne: Advisory Panel; Self; Novo Nordisk Inc. Research Support; Self; Sanofi. B. Neuschwander-Tetri: Advisory Panel; Self; 89Bio, Allysta, ARTham, Blade, Bristol-Myers Squibb, Gelesis, GENFIT, Histoindex, Madrigal Pharmaceuticals, Inc., Medpace, Merck & Co., Inc., Sagimet, Siemens Corporation. Consultant; Self; Arrowhead Pharmaceuticals, Inc., Axcella, DURECT Corporation, Enanta Pharmaceuticals, Inc., Fortress, Indalo, Innovo, Lipocine, Mundipharma International, pH-Pharma, TARGET PharmaSolutions. A. Sanyal: Consultant; Self; Intercept Pharmaceuticals, Inc., Lilly Diabetes, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Pfizer Inc. Stock/Shareholder; Self; DURECT Corporation, GENFIT, HemoShear, Sanyal Bio, Tiziana Life Sciences plc. Funding TARGET-NASH

Nonalcoholic Fatty Liver Disease (NAFLD), ranging from simple steatosis to its more severe form, steatohepatitis (NASH), is an increasingly common problem in patients with T2DM and is associated with progression to cirrhosis and extrahepatic complications (i.e., cardiovascular disease [CVD]). There is limited information on the clinical profile of T2DM patients with NASH in “real world” practice. Accordingly, we studied the clinical profile of participants (pts) with NASH, with or without T2DM (nonDM), enrolled in TARGET-NASH, a large longitudinal observational study of patients with NAFLD followed at 54 sites (39 academic/15 community) across the U.S. Data collected from medical records (including lab data, imaging, pathology, procedures, and outcomes) is sent to a central database utilizing novel data abstraction technology. Among 1743 pts studied to date in TARGET-NASH, 1261 had NASH diagnosed by biopsy or clinical criteria (699 T2DM and 562 nonDM). Pts with T2DM and NASH were older (median 61 vs. 56 years) and had a higher BMI than nonDM (34.0 vs. 32.0 kg/m2, both p Disclosure K. Cusi: Consultant; Self; Janssen Global Services, LLC., Eli Lilly and Company. Research Support; Self; Cirius Therapeutics. Other Relationship; Self; Nordic Bioscience. Research Support; Self; Novartis Pharmaceuticals Corporation, Novo Nordisk Inc.. Other Relationship; Self; Quest Diagnostics. Research Support; Self; Zydus Pharmaceuticals (USA) Inc.. Other Relationship; Self; OWL metabolomics, Echosens. Research Support; Self; Janssen Global Services, LLC.. Consultant; Self; Tobira Therapeutics, Pfizer Inc. A.S. Barritt: Consultant; Self; Targetpharma solutions. Consultant; Spouse/Partner; Targetpharma solutions, Takeda Pharmaceuticals U.S.A., Inc., AbbVie Inc.. V. Clark: None. R.J. Firpi: None. S. Klein: Stock/Shareholder; Self; Aspire Bariatrics. Consultant; Self; Pfizer Inc.. Research Support; Self; Merck & Co., Inc., Johnson & Johnson Services, Inc., REMD Biotherapeutics. A. Lok: None. R. Loomba: Research Support; Self; Adheron, Arora, BMS, Daiichi-Sankyo Inc., Galectin, Galmed, GE, Genfit, Gilead, Immuron, Intercept, Kinemed, Madrigal, Merck, NGM, Promedior, Prometheus, Siemens, Sirius, Tobira. Advisory Panel; Self; Arrowhead Research, Conatus, Galmed, Gilead, Intercept, NGM, Nimbus, Octeta, Tobira. Consultant; Self; Alnylam, Bird Rock Bio, BMS, Boehringer Ingleheim, Celgene, Conatus, DeuteRx, Eli Lily, Enanta, Fibrogen, Genkyotex, Gilead, GRI Bio, ISIS, Janssen Inc.Kirin, Madrigal, Metacrine, NGM, Nitto Denko, Pf, Sanofi,Scholar Rock, Shire, Tasly, Viking, Yuhan Pharmaceuticals, Zafgen. L. Malahias: None. B. Neuschwander-Tetri: None. C. Schoen: None. K. Reddy: Advisory Panel; Self; Gilead Sciences, Inc., Merck & Co., Inc., AbbVie Inc.. Other Relationship; Self; Novartis AG, Gilead Sciences, Inc., Merck & Co., Inc., AbbVie Inc., Mallinckrodt Pharmaceuticals, Conatus Pharmaceuticals Inc., Intercept Pharmaceuticals, Inc.. J.L. Taunk: None. K. Wyne: Research Support; Self; Sanofi. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Eli Lilly and Company. A.J. Sanyal: Stock/Shareholder; Self; Sanyal Bio, Genfit, Durect, Indalo, Exhalenz. Consultant; Self; Gilead, Boehringer Ingelheim, Intercept. Advisory Panel; Self; Galectin, NGM. Consultant; Self; Pfizer.