| Elafibranor (GFT-505) (34) |
PPAR-α/δ agonist |
NASH F1-3 |
3-RESOLVE-IT (NCT02704403) |
NASH resolution without worsening of fibrosis (on histology) |
Phase 3 data not available. Phase 2b data show improved metabolic features of NASH and favorable cardiometabolic profile |
| Resmetirom (MGL-3196) (35) |
Selective THRβ agonist |
NASH F1-3 |
2-MGL-3196 (NCT02912260) |
Change from baseline in fat fraction on MRI-PDFF |
Reduction in fat fraction in addition to improvement in lipid profile, liver biochemistries, and NASH histology |
| NASH F2-3 |
3-MAESTRO-NASH (NCT03900429) |
NASH resolution on histology |
No data available |
| VK2809 (36) |
Selective THRβ agonist |
NAFLD with ≥8% Fat fraction and high LDL |
2-VK2809 (NCT02927184) |
Change in LDL cholesterol |
Phase 3 data not available. Phase 2b data show histological improvement of fibrosis without worsening of NASH |
| Obeticholic Acid (OCA, INT-747) (37-40) |
FXR Agonist |
NASH F2-3 |
3-REGENERATE (NCT02548351) |
NASH resolution without worsening of fibrosis and fibrosis improvement without worsening of NASH (on histology) |
Histological improvement in fibrosis without worsening of NASH (Interim data of Phase 3) |
| NASH F4 |
2-REVERSE (NCT03439254) |
Fibrosis improvement without worsening of NASH (on histology) |
No data available |
| Tropifexor (TXR, LJN452) (41-43) |
FXR Agonist |
NASH F1-3 |
2-FLIGHT-FXR (NCT02855164) |
Change in transaminases and change in fat percentage on MRI |
Decrease in ALT, GGT, and liver fat content on MRI |
| Cilofexor (GS-9674) (44) |
FXR Agonist |
NASH F1-3 |
2-GS-9674 (NCT02854605) |
Overall safety (Adverse events and lab abnormalities) |
Reduction in liver biochemistry serum bile acids, and liver fat content on MRI |
| NGM282 (45) |
FGF 19 analogue |
NASH F2-3 |
2-NGM282 (NCT02443116) |
Improvements in liver fat content on MRI |
Improvements in liver fat content on MRI, serum markers of fibrosis and histological NASH |
| 2b-NGM282 (NCT03912532) |
Histological improvement of NASH |
No data available |
| BMS-986036 (46) |
Pegylated FGF 21 |
NASH F1-3 |
2-BMS-986036 (NCT02413372) |
Improvements in liver fat content on MRI |
Improvements in liver fat content on MRI, lipids and serum markers of fibrosis. |
| NASH F3 |
2b-FALCON 1 (NCT03486899) |
NASH resolution without worsening of fibrosis and fibrosis improvement without worsening of NASH (on histology) |
No data available |
| NASH F4 |
2b-FALCON 2 (NCT03486912) |
Fibrosis improvement without worsening of NASH (on histology) |
No data available |
| Aramchol (47) |
SCD1 inhibitor |
NASH F0-3 |
2-ARREST (NCT02279524) |
Change in liver on MR Spectroscopy (MRS) |
Reduced liver fat on MRS, improvements in histology, liver biochemistries, and glycemic control |
| Cenicriviroc (CVC) (48) |
C-C chemokine receptor 2/5 antagonist |
NASH F1-3 |
3-AURORA (NCT03028740) |
Histological improvement of NASH |
Phase 3 data not available. Phase 2b data show histological improvement of fibrosis without worsening of NASH |
| Selonsertib (SEL, GS-4997) (49-52) |
Apoptosis signal-regulating kinase 1 inhibitor |
NASH F3 |
3-STELLAR 3 (NCT03053050) |
Fibrosis improvement without worsening of NASH (on histology) |
No benefit in fibrosis improvement (Interim data of Phase 3 data) |
| NASH F4 |
3-STELLAR 4 (NCT03053063) |
Fibrosis improvement without worsening of NASH (on histology) |
No benefit in fibrosis improvement (Interim data of Phase 3 data) |
| Severe alcoholic hepatitis |
2-SEL + Prednisone (NCT02854631) |
Overall safety (Adverse events and lab abnormalities) |
No benefit in infection or mortality |
| Firsocostat (GS-0976)(53) |
Acetyl-coenzyme A carboxylase inhibition |
NASH F1-3 |
2-GS-0976 (NCT02856555) |
Overall safety (Adverse events) |
Improvements in liver fat content on MRI, liver biochemistries and serum markers of fibrosis |
| Liraglutide (54) |
GLP-1 analogue |
NASH F0-4 |
2-LEAN (NCT01237119?) |
Histological improvement of NASH |
NASH resolution on histology |
| Semaglutide |
GLP-1 analogue |
NASH F1-3 |
2-Semaglutide (NCT02970942) |
NASH resolution without worsening of fibrosis (on histology) |
No data available |
| NASH F4 |
2-Semaglutide (NCT03987451) |
Change in liver stiffness on MRE |
No data available |
| S-adenosyl-methionine (55) |
Methionine metabolite |
Alcohol related liver disease |
2-SAM (NCT00573313) |
Change in serum AST and liver histopathology |
No improvement in liver biochemistries or histology |
| Granulocyte-colony stimulating factor (G-CSF) (56) |
Bone marrow stimulant (cytokine) |
Severe alcoholic hepatitis |
2-G-CSF (NCT01820208). |
Survival at 1 and 3 months |
Survival benefit at 3 months, but not at 1 month |
| 3-G-CSF (NCT03703674) |
Survival at 3 months |
No data available |
