Table 1.
Medications Undergoing Phase III Clinical Trials for the Treatment of NAFLD
| Phase II Efficacy Data | ||||||
|---|---|---|---|---|---|---|
| Medication | Mechanism | Resolution of NASH | Decrease in Fibrosis Stage | Phase III RCT | Effective Dosage | Planned Interim Analysis Duration |
| Elafibranor | PPARα/δ agonist | Yes | No | RESOLVE‐IT | 120 mg/day | 72 weeks |
| OCA | FXR agonist | No | Yes | REGENERATE | 10‐25 mg/day | 72 weeks |
| CVC | CCR2/CCR5 antagonist | No | Yes | AURORA | 150 mg/day | 52weeks |
| SEL | ASK1 inhibitor | No | Yesa | STELLAR 3 and 4 | 6 and 18 mg/day | 48 weeks |
a
Numerically higher rates of fibrosis improvement that did not reach statistical significance. This was a proof‐of‐concept study that was not powered to detect histological changes in fibrosis stage.