Mount Sinai NASH/NAFLD Program/Center of Excellence

Mission: To provide exemplary clinical care to all patients with NASH/NAFLD through standardization of clinical protocols and innovative clinical/translational studies and to elucidate molecular, cellular, immunological pathogenic pathways and predictors of disease progression (genetic/biomarkers/phenotyping algorithms).

Goals/Objectives:

  • Develop, validate, and implement robust screening protocols to identify patients with fatty liver and fibrosis in primary care, specialty clinics (Endocrinology, Cardiology, Obstetrics/ /Gynecology, Obesity Medicine, ID (HIV)), and special populations (toxicant-associated NASH).
  • Conduct translational studies testing novel candidate NASH therapies in animal models, cell culture and precision cut liver slices.
  • Develop standard care and referral pathways with linkage to investigator supported or initiated clinical/translational research studies.
  • Establish a longitudinal NASH registry with linkage to biobanked samples (liver tissue, serum, plasma, urine, stool), radiographic, genetic, and clinical information.
  • Provide an easily accessible web-based list of clinical trials for both provider and patient self-referrals throughout the Mount Sinai Health System.
  • Advance mechanistic and translational research by leveraging the patient-based and animal models core and laboratory-based investigations.

Clinical Trials Core: Meena Bansal (Lead), Andrea Branch, Douglas Dieterich, Amreen Dinani, Josep M. Llovet  

Biobank/Biomarker Core: Augusto Villanueva (Lead), Meena Bansal, James Crismale, Josep M. Llovet  

Genomics Core: Noura Abul Husn (Lead), Stephanie Rutledge

Molecular/Models Core: Scott Friedman, (Lead), Bishaung Cai, Jaime Chu

Imaging Core: Bachir Taouli (Lead), Sara Lewis

Pathology Core: Isabel Fiel (Lead)

Care Standardization Core: Amreen Dinani (Lead), Tatyana Kushner , Douglas Dieterich, Meena Bansal, Andrea Branch, Jaime Chu, Anna Mageras

Quality Improvement Core: Ritu Agarwal (Lead)

Statistical Core: TBD

Development Core: Meena Bansal, Douglas Dieterich, Scott Friedman, Andrea Branch

Patient Risk Stratification Core: Andrea Branch (Lead), Meena Bansal, Girish Nadkarni

Epidemiology Core: Tae Hoon Lee (Lead)

Industry Partnerships Core: Scott Friedman (Lead), Meena Bansal, Augusto Villaneuva

Core: Jaime Chu (Lead), John Bucuvalas

Ritu Agarwal (Quality Improvement Core)
Dr. Agarwal is an accomplished clinician-educator with special expertise in quality care and improvement.   She is the quality officer for the Division of Liver Diseases and a widely respected hepatologist, educator and mentor.

Meena Bansal (Care Standardization Core, Clinical Trials Core)
Dr. Bansal is a NIH funded investigator with a long-standing interest in studying molecular mechanisms of liver fibrosis. She has served as the Principal Investigator for numerous clinical trials for NASH, has developed a screening protocol and database for HIV patients with NAFLD/NASH, and serves on a number of industry advisory boards focused on novel NASH therapeutics. As Vice-President in Population Health, she is interested in care standardization and risk stratification for the detection and treatment of NAFLD/NASH across Mount Sinai’s Clinically Integrated Network.

Andrea Branch (Care Standardization Core, Clinical Trials Core)
Dr. Branch is the director of basic and translational research in the Institute of Liver Medicine. She and her colleagues, including Drs. Claudia Henschke and Li Li, developed high-quality phenotyping algorithms for primary and secondary NASH, liver cancer, and viral hepatitis; and computer algorithms for automatically diagnosing liver steatosis in chest CT scans. Her team is currently analyzing macrophage subpopulations in liver and adipose tissue of patients undergoing bariatric surgery, in collaboration with Dr. Daniel Herron.

John Bucuvalas
Population-based studies suggest nearly 1 in 4 Hispanics have NAFLD.  The literature suggests that about 20% of these children develop advanced fibrosis. It’s hard to say how many kids will develop hepatocellular carcinoma or require liver transplantation as they become adults but it’s not trivial. We seek to identify actionable genetic and environmental factors to mitigate risk before the kids become adults

Bishaung Cai (Molecular/Models Core)
We are interested in elucidating the mechanisms of dysregulated biosynthesis of PUFA-derived specialized pro-resolving mediators in macrophage and its consequences to NASH, hoping to identify unique resolving pathways that hold promise for future therapies to NASH.

Jaime Chu (Care Standardization Core, Molecular/Models Core)
Jaime Chu, MD is the Associate Chief of the Division of Pediatric Hepatology and Medical Director of Pediatric Liver Transplantation.  The Division of Pediatric Hepatology is involved in 1) laboratory research in fibrosis in NAFLD, 2) identification of genetic risk factors in pediatric obesity and NAFLD, and 3) a comprehensive, family-centered, and multi-disciplinary approach in the clinical care of children and families with NAFLD. 

Douglas Dieterich  (Care Standardization Core, Clinical Trials Core)
Dr. Dieterich is the founder and President of Nash net an International group dedicated to the study of NASH. He is an investigator for several ongoing studies evaluating the safety and efficacy of various antiviral treatment regimens for chronic hepatitis B & C, NASH and PSC.

Amreen Dinani  (Care Standardization Core, Clinical Trials Core)
Dr. Dinani's clinical and research interest is creating pathways to identify, and risk stratify populations at high risk for NASH and developing multidisciplinary approach to disease management. In addition, she is interested in developing programs to support lifestyle intervention and collaboration with Apps to develop sustainable weight loss and lifestyle programs. 

Isabel Fiel (Pathology Core)
Maria Isabel Fiel, MD, is a liver pathologist with long-standing experience in the evaluation of NAFLD and metabolic liver diseases. She has been active in research pertaining to alcohol and nonalcohol-associated liver injury, HCC, and liver transplant pathology. She has been a central pathologist in many clinical trials, as well as in pre-clinical and animal studies of NASH therapeutics.

Scott Friedman (Molecular/Models Core)
Dr. Friedman is a widely recognized key opinion leader who studies the pathogenesis of hepatic fibrosis in NASH and its link to liver cancer, as well as NASH therapeutic targets and their translation into novel therapies and diagnostics.  In addition to NIH-supported basic research, his laboratory partners closely with biotech and pharmaceutical companies to test novel agents in unique culture systems and animal models of NASH fibrosis and liver cancer.

Noura Abul Husn (Genomics Core)
Dr. Noura Abul-Husn is the founding Chief of the Division of Genomic Medicine, Clinical Director of the Institute for Genomic Health, and Associate Professor of Medicine and Genetics at the Icahn School of Medicine at Mount Sinai. She has expertise in applying genome-first approaches to EHR-linked biobanks, which led to the discovery and characterization of a novel protein-truncating variant in HSD17B13 that protects from NASH and cirrhosis (Abul-Husn, NEJM 2018). Her current focus is to ameliorate genomic risk prediction for NASH and its progression in diverse populations.

Tatyana Kushner  (Care Standardization Core)
Tatyana Kushner, MD, MSCE is an Assistant Professor in the Division of Liver Diseases with a joint appointment in the Department of Obstetrics and Gynecology. She is particularly interested in the impact of NAFLD/ NASH on pregnancy and adverse pregnancy outcomes, as well as women's health. She is a co-investigator of multiple NAFLD clinical trials and a co-investigator in NASHNet, which focuses on defining the natural history of NAFLD and identifying patients with NAFLD in clinical practice.

Tae Hoon Lee
Tae Hoon Lee, MD is an Assistant Professor in the Division of Liver Diseases at the Icahn School of Medicine at Mount Sinai and a full-time staff physician at the James J. Peters VA Medical Center (Bronx). He is a member of VHA Hepatology Field Advisory Board subcommittee in area of NAFLD. He is interested in the epidemiology of  NAFLD and big data analysis using VA Informatics and Computing infrastructure (VINCI) to identify risk factors for NAFLD progression.


Sara Lewis (Imaging Core)
Dr. Sara Lewis is a diagnostic radiologist with expertise in abdominal imaging, who is actively involved in translational research involving the characterization of hepatobiliary diseases. Specifically, she is highly interested in and engaged in research involving the investigation of multiparametric MRI methods and other quantitative imaging biomarkers of liver cancer and diffuse liver disease, such as liver steatosis and NASH. 

Josep M. Llovet (Biobank/Biomarker Core, Clinical Trials Core)
Josep M Llovet, MD, PhD is Director of the Mount Sinai Liver Cancer Program and Professor of Medicine, at Icahn School of Medicine at Mount Sinai, Full Professor of Medicine – Hepatic Oncology at the University of Barcelona and Professor of Research ICREA-Hospital Clínic. He has devoted 25 years of his career to study liver cancer and is a key opinion leader due to his clinical (led clinical trials of sorafenib, regorafenib, ramucirumab and chemoembolization; AASLD, EASL and ESMO guidelines) and translational achievements (molecular and immune classification of hepatocellular carcinoma, and characterization of NASH-HCC). Founder, Secretary and President of the International Liver Cancer Association (ILCA). He has been acknowledged as a top 1% scientist by Clarivate from 2014-2020, producing more 300 papers with > 80,000 citations, five out of the top-10 most cited articles in HCC globally. He received funding from NIH, DoD and European Commission grants (FP7-2010-Health, H2020).  

Girish Nadkarni
Girish is the Irene and Dr. Arthur Fishberg Professor of Medicine and the Inaugural Chair of the Division of Data Driven and Digital Medicine (D3M). He is utilizing his experience with data science and electronic phenotyping to create scalable and accurate phenotyping algorithms and predictive approaches for NASH

Stephanie Rutledge  (Genomics Core)
Stephanie Rutledge is a gastroenterology fellow with an interest in liver diseases, specifically in the effects of genomics on the risk of non-alcoholic fatty liver disease and alcohol-associated liver disease. She is also interested in how we can use the electronic medical record and natural language processing to identify NAFLD phenotypes.

Thomas Schiano
Dr. Schiano has an interest in diagnosing and treating mimickers of NASH, such as certain metabolic liver diseases, as well as specializing in the care of patients having cirrhosis, those requiring liver transplantation, and in managing NASH in the post-liver transplant setting.

Bachir Taouli (Imaging Core)
Bachir Taouli, MD, MHA is Professor of Radiology and Medicine in the Abdominal Imaging/Body MRI Section in the Department of Radiology, and the BioMedical Engineering and Imaging Institute (BMEII) at the Icahn School of Medicine at Mount Sinai in New York. Dr. Taouli is a clinician scientist with expertise in the application of advanced MRI methods applied to diffuse liver disease and liver cancer, and has been successfully NIH funded since 2010. He directs the Body MRI quantitative group at BMEII.

Augusto Villanueva  (Biobank/Biomarker Core)
Hepatologist with extensive experience in bioarmker development for early detection, prognosis and treatment prediction in patients with liver cancer using tissue and blood samples. Co-Chair of the ILCA white paper on biomarker development for liver cancer, who led the enrollment of +450 patients in a prospective protocol to study the role of liquid biopsy for biomarker development  in liver diseases.

NASH Clinical Trials

Updated 7/29/2021

A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to  cirrhosis and/or Hepatic Decompensation  (phase III)

Disease: NASH progression to Cirrhosis Population  ≥18 years of age
P.I : Dr Meena Bansal
CRC: Meredith Lewis  Office: 212.824.7931 meredith.lewis@mssm.edu

A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients with Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)  

Disease NAFLD  Population   ≥ 18 years
P.I : Dr Meena Bansal
CRC: Meredith Lewis  Office: 212.824.7931 meredith.lewis@mssm.edu

Evaluation of Efficacy, Safety and Tolerability of NGM282 (Aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to NASH (ALPINE 4)

Disease NASH  Population 18 to 80 years of age (inclusive)
P.I : Dr Meena Bansal
CRC: Clara Rodriguez-Rivas Mobile: 332.215.2856 clara.rodriguezrivas@mountsinai.org

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH) (phase II)

Disease: NASH Induced cirrhosis   Population between 18 and 75 years of age, inclusive
P.I : Dr Amreen Dinani
CRC: Clara Rodriguez-Rivas Mobile: 332.215.2856 clara.rodriguezrivas@mountsinai.org

A randomized, multicenter, double-blinded, parallel-group, trial comparing semaglutide s.c. 2.4 mg once weekly versus placebo s.c. once weekly in subjects with NASH and F2 or F3 (phase III)

Disease NASH   Population of age above or equal to 18 years
P.I : Dr Amreen Dinani
CRC: Clara Rodriguez-Rivas Mobile: 332.215.2856 clara.rodriguezrivas@mountsinai.org

Pfizer C2541013:
A Phase 2, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Dose-Ranging, Dose-Finding, Parallel
Group Study to Assess Efficacy and Safety of Pf-06865571 (dgat2i) Alone and When Coadministered with Pf-05221304 (acci) in Adult Participants With Biopsy-Confirmed Nonalcoholic Steatohepatitis and Fibrosis Stage 2 or 3
P.I : Dr Amreen Dinani
CRC: Ani Cotarlan, ani.cotarlan@mountsinai.org

Galectin GT-031 (NASH-RX):
A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis
P.I : Dr Ilan Weisberg
CRC: Ani Cotarlan, ani.cotarlan@mountsinai.org

To find our clinical trials please go here: http://icahn.mssm.edu/research/clinical-trials

Please click here to see our NASH-related publications.