Table 2.
Current status of emerging drugs from phase 3 clinical trials of nonalcoholic steatohepatitis
| Drug | Target | Population | Study name | Status |
|---|---|---|---|---|
| Obeticholic acid | Farnesoid X receptor agonist | NASH with F2-F3 fibrosis | REGENERATE | Ongoing |
| Lanifibranor | Pan-PPAR agonist | NASH with F2-F3 fibrosis | NATiV3 | Ongoing |
| Resmetirom | Thyroid hormone receptor-beta agonist | NASH with F1-F3 fibrosis | MAESTRO-NASH | Ongoing |
| Semaglutide | Glucagon-like peptide-1 (GLP-1) agonist | NASH with F2-F3 fibrosis | ESSENCE | Ongoing |
| Cotadutide | dual GLP-1 and glucagon receptor agonist | NASH with F2-F3 fibrosis | PROXYMO-ADV | Ongoing |
| Obeticholic acid | Farnesoid X receptor agonist | NASH with compensated LC | REVERSE | Halted |
| Elafibranor | PPAR-alpha and -delta agonist | NASH with F1-F3 fibrosis | RESOLVE-IT | Halted |
| Selonsertib | Apoptosis signal-regulating kinase inhibitor | NASH with F3 fibrosis | STELLAR-3 | Halted |
| Selonsertib | Apoptosis signal-regulating kinase inhibitor | NASH with compensated LC | STELLAR-4 | Halted |
| Cenicriviroc | Inhibitor of CC chemokine receptors 2 and 5 | NASH with F2-F3 fibrosis | AURORA | Halted |
| Aramchol | Fatty acid bile acid conjugate | NASH with F1-F3 fibrosis | ARMOR | Suspended* |
PPAR, peroxisome proliferator-activated receptor; NASH, nonalcoholic steatohepatitis; LC, liver cirrhosis.
*
Starting the double-blind part of phase 3 trial is delayed due to the formulation of Aramchol Meglumine.