Table 1-.
List of completed and on-going clinical trials investigating the use of FXR agonists and FGF19 analogs for the treatment of NASH.
| Mechanism | Compound | Phase | Study Title | Start Date | End Date | NCT ID# |
|---|---|---|---|---|---|---|
| FXR agonist | OCA | 3 | Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE) | 9/2015 | 10/2022 | |
| 3 | Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (REVERSE) | 8/2017 | 7/2021 | |||
| 2 | The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial (FLINT) | 3/2011 | 9/2014 | |||
| 1 | Obeticholic Acid in Morbidly Obese Patients and Healthy Volunteers (OCAPUSH) | 8/2015 | 10/2019 | |||
| 1 | Hepatic Impairment Trial of Obeticholic Acid | 6/2013 | 10/2013 | |||
| 1 | Effect of Food on Pharmacokinetics of Obeticholic Acid (OCA) | 8/2013 | 11/2013 | |||
| 1 | Single Dose and Multiple Dose Trial to Assess Pharmacokinetics of Obeticholic Acid (OCA) | 10/2013 | 11/2013 | |||
| Tropifexor (LJN452) | 2 | Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis (TANDEM) | 8/2018 | 6/2020 | ||
| 2 | Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH) (FLIGHT-FXR) | 8/2016 | 9/2019 | |||
| EDP305 | 2 | A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis | 4/2018 | 4/2019 | ||
| 1 | Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers | 7/2017 | 9/2017 | |||
| 1 | A Study of EDP-305 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers | 6/2017 | 9/2017 | |||
| 1 | Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers | 5/2017 | 6/2017 | |||
| 1 | A Study of EDP 305 in Healthy Subjects and Subjects With Presumptive NAFLD | 9/2016 | 6/2017 | |||
| GS-9674 | 2 | Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (ATLAS) | 3/2018 | 4/2020 | ||
| 2 | Safety, Tolerability, and Efficacy of Selonsertib, GS-0976, and GS-9674 in Adults With Nonalcoholic Steatohepatitis (NASH) | 7/2016 | 7/2019 | |||
| 2 | Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) | 10/2016 | 1/2018 | |||
| 1 | Pharmacokinetics and Pharmacodynamics of GS-9674 in Adults With Normal and Impaired Hepatic Function | 7/2016 | 12/2018 | |||
| 1 | Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674, and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics | 1/2016 | 7/2016 | |||
| Nidufexor (LMB763) | 2 | Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH | 10/2016 | 3/2019 | ||
| Turofexorate (FXR450) | 1 | Study Evaluating the Safety of FXR-450 in Healthy Subjects | 10/2007 | 2/2008 | ||
| EYP001 | 1 | Study Evaluating Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects | 8/2016 | 3/2017 | ||
| FGF19 analog | NGM282 | 2 | Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH) | 5/2015 | 9/2019 | |
| 1/2 | Study of NGM282 in Subjects With Functional Constipation and Healthy Individuals | 12/2015 | 1/2017 | |||
| 1 | SAD and MAD Study of NGM282 in Healthy Adult Participants | 1/2013 | 7/2013 | |||
| FGFR1-βKL activating antibody | NGM313 | 1 | Study of NGM313 in Obese Participants | 9/2017 | 12/2018 | |
| 1 | Study of NGM313 in Healthy Adult Participants | 2/2016 | 4/2017 |