Philadelphia University + Thomas Jefferson University

Research Projects

Research Projects

Nonalcoholic fatty liver disease and non-alcoholic steatohepatitis

  • A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis – The REGENERATE Study 

Up to 6 year trial includes NASH patients with F1-F3 fibrosis on liver biopsy within 6 months of screening (biopsy can be completed as part of screening process at no cost to patient). Main exclusion criteria include cirrhosis, uncontrolled DM (HBA1C >9.5), CHF, recent bariatric surgery (within 5 years), heavy EtOH use or other liver disease (not including HCV with SVR).


  • Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects with Nonalcoholic Steatohepatitis (NASH)

Up to 2 year trial in which all subjects will receive OCA and possible atorvastatin treatment. Includes NASH patients F1-F4 (even cirrhosis) with biopsy within 1 year prior to screening. Main exclusion criteria include inability to tolerate statin, uncontrolled DM (HBA1C >9.5), CHF, recent bariatric surgery (within 5 years), heavy EtOH use or other liver disease (not including HCV with SVR).


  • A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of GR-MD-02 for the Treatment of Liver Fibrosis and Resultant Portal Hypertension in Patients with NASH Cirrhosis- The NASH-CX Trial

52 week study for patients with NASH related cirrhosis and portal hypertension. Patient will need to come to Jefferson every 2 weeks for infusion. Trans jugular liver biopsy with pressure measurements and EGD completed during screening. Main exclusion criteria include decompensated cirrhosis with history of ascites, hepatic encephalopathy, variceal bleeding, previous banding or TIPS.


  • A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults with Non-alcoholic Steatohepatitis   (also a NAFLD substudy)

16 week daily injection including NASH patients with F1-F3 fibrosis on biopsy within 1 year of screening. Main exclusion criteria include cirrhosis,n recent bariatric surgery (within 5 years), heavy EtOH use or other liver disease. Patient must be willing to undergo MR elastography as this is the primary tool being used to determine effectiveness in this study.

*Substudy of NAFLD patients also going on with no liver biopsies needed.


  • Phase III Randomized, Double Blind, Placebo Controlled Trial  to Evaluate the Efficacy and Safety of Elafibranor (GFT-505) in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis

72 week trial includes NASH patients with F1-F3 fibrosis on liver biopsy within 6 months of screening (biopsy can be completed as part of screening process at no cost to patient). Main exclusion criteria include cirrhosis, uncontrolled DM (HBA1C >9), CHF, recent bariatric surgery (within 5 years), heavy EtOH use or other liver disease (not including HCV with SVR).