Table 2.
Pharmacologic agents for NASH currently undergoing phase 2 and 3 clinical trials.
| AGENT | MECHANISM | STUDY DESIGN | PATIENT POPULATION | NUMBER OF PATIENTS | DURATION |
|---|---|---|---|---|---|
| Elafibranor | PPAR α/δ agonist | Phase 3 Randomized, double blind |
NASH and fibrosis | 2224 | 72 weeks |
| Liraglutide | GLP-1 agonist | Phase 3 Safety/efficacy Non randomized, open label |
NASH and obesity | 36 | 12 months |
| Obeticholic acid | FXR agonist | Phase 3 Randomized, double blind |
NASH fibrosis | 2000 | 18 months and 8 years |
| Saroglitazar | PPAR α/γ agonist | Phase 3 Randomized, single blind |
NASH | 100 | 24 weeks |
| Aramchol | Fatty acid/bile acid conjugate | Phase 2b Randomized, double blind |
NASH | 240 | 52 weeks |
| Cenicriviroc | CCR2/CCR5 antagonist | Phase 2b Randomized, double blind |
NASH fibrosis | 289 | 52 and 104 weeks |
| Emricasan | Pan-caspase protease inhibitor | Phase 2b Randomized, double blind |
NASH fibrosis | 330 | 72 weeks |
| Simtuzumab | Anti-LOXL2 mAb | Phase 2b Randomized, double blind |
Advanced NASH fibrosis but not cirrhosis | 222 | 96 and 240 weeks |
| Amlexanox | IKKε/TBK1 inhibitor | Phase 2 Safety/efficacy, single-group, open-label |
Hepatic steatosis, T2DM and obesity | 15 | 12 weeks |
| BMS-986036 | FGF-21 analog | Phase 2 Randomized, double blind |
NASH | 105 | 142 days |
| GR-MD-02 | Galectin-3 inhibitor | Phase 2 Randomized, double blind |
NASH cirrhosis | 156 | 52 weeks |
| GS-4997 | ASK1 inhibitor | Phase 2 Safety/efficacy, single-group, open-label |
Hepatic steatosis and elevated liver stiffness | 10 | 12 weeks |
| IMM-124e | IgG-rich bovine colostrum | Phase 2 Randomized, double blind |
NASH | 120 | 24 weeks |
| NGM-282 | FGF-19 analog | Phase 2 Randomized, double blind |
NASH | 80 | 12 weeks |
| Solithromycin | Ketolide antibiotic | Phase 2 Safety/efficacy, single-group, open-label |
NASH | 15 | 13 weeks |
| Tesamorelin | GHRH analog | Phase 2 Randomized, double blind |
Hepatic steatosis and HIV | 60 | 12 months |
| Tipelukast | Anti-LO/LT | Phase 2 Safety/efficacy, single-group, open-label |
NAFLD and hypertriglyceridemia | 40 | 12 weeks |
| Volixibat | ASBT inhibitor | Phase 2 Randomized, double blind |
NASH | 266 | 48 weeks |
Abbreviations: ASBT, apical sodium-dependent bile acid transporter; ASK, apoptosis signal-regulating kinase; CCR2/CCR5, C-C chemokine receptor type 2 and type 5; FGF, fibroblast growth factor; FXR, farsenoid X receptor; GHRH, growth hormone releasing hormone; GLP, glucagon-like peptide; HIV, human immunodeficiency virus; IgG, immunoglobin G; IKKε/TBK1, I-kappaB-related kinase/TANK binding kinase; LO/LT, lipoxygenase/leukotriene; LOXL2, lysyl oxidase-like-2; mAb, monoclonal antibody; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; PPAR, peroxisome proliferator-activated receptor; T2DM, type 2 diabetes mellitus.