Table 2. New agents in phase III RCTs for the treatment of NASH and NASH fibrosis.
| Medication | Mechanism | Effective dose (mg/day) | Phase II efficacy data | Phase III RCT | Planned interim analysis duration (weeks) | |
|---|---|---|---|---|---|---|
| Resolution of NASH | Decrease in fibrosis stage | |||||
| Obeticholic acid | FXR agonist | 10–25 | No | Yes | REGENERATE (NCT02548351) | 72 |
| Elafibranor | PPARα/δ agonist | 120 | Yes | No | RESOLVE-IT (NCT02704403) | 72 |
| Cenicriviroc | CCR2/CCR5 antagonist | 150 | No | Yes | AURORA (NCT03028740) | 52 |
| Selonsertib | ASK1 inhibitor | 6 and 18 | No | Yes | STELLAR 3 (NCT03053050), STELLAR-4 (NCT03053063) | 48 |
NASH, nonalcoholic steatohepatitis; RCT, randomized clinical trial; FXR, farnesoid X receptors; PPAR, peroxisome proliferator-activated receptor; CCR, C-C chemokine receptor.