Emerging drugs for non-alcoholic steatohepatitis in phase III trials
| Mechanism of action | Drug | Primary endpoint(s) | Clinical trial | Expected completion date |
|---|---|---|---|---|
| PPAR α/δ agonist | Elafibranor | • Resolution of NASH without worsening of fibrosis | RESOLVE-IT NCT02704403 | December 2021 |
| • Composite endpoint: all-cause mortality, cirrhosis and liver-related clinical outcomes | ||||
| ASK1 inhibitor | Selonsertib | • ≥1 stage improvement in fibrosis | STELLAR 4 | January 2020 |
| • Event-free survival at 240 weeks | NCT03053063 | |||
| FXR agonist | Obeticholic acid | • Composite endpoint: all-cause mortality, MELD score ≥15, liver transplant, histological progression to cirrhosis, hepatic decompensation (HCC, ascites, variceal bleed, hepatic encephalopathy, SPB) | REGENERATE NCT02548351 | October 2021 |
| • Fibrosis improvement composite endpoint: improvement in ≥1 stage of fibrosis; NASH resolution with no worsening of fibrosis | ||||
| CCR2/5 antagonist | Cenicriviroc | • Improvement in ≥1 stage of fibrosis and no worsening of NASH | AURORA NCT03028740 | July 2019 |
| • Clinical outcomes composite endpoint: histological progression to cirrhosis, liver-related clinical outcomes, all-cause mortality |
ASK = apoptosis signal-regulating kinase; CCR = cysteine-cysteine motif chemokine receptor; FXR = farnesoid X receptor; MELD = model for end stage liver disease; NASH = non-alcoholic steatohepatitis; PPAR = peroxisome proliferator-activator receptors