Table 1.
Drugs currently explored in phase 3 clinical trials
| Drug | Elafibranor | Cenicriviroc | Obeticholic acid | Aramchol | Resmetirom (MGL-3196) |
|---|---|---|---|---|---|
| MoA | PPARα/δ agonist | CCR2/CCR5 antagonist |
FXR agonist | SCD-1 modulator | Thyroid-β Agonist |
| Study name | RESOLVE-IT (NCT02704403; Genfit, Loos, France) | AURORA (NCT03028740; Allergan, Dublin, Ireland) | REGENERATE (NCT02548351; Intercept Pharmaceuticals, New York, NY, USA) | ARMOR Galmed Pharmaceuticals, Tel Aviv, Israel) | MAESTRO-NASH (NCT03900429; Madrigal Pharmaceuticals, West Conshohocken, PA, USA) |
| Study population,n | 2,000 | 2,000 | 2,480 | 2,000 | 2,000 |
| Phase 2 results | GOLDEN | CENTAUR | FLINT | ARREST | MGL-3196 |
| (n = 276) | (n = 289) | (n = 273) | (n = 247) | (n = 125) | |
| Follow-up, weeks | 52 | 54 | 72 | 52 | 12 |
| Improvement | |||||
| NAS | + (post hoc) | − | + | − | −1 |
| Fibrosis | (+) Responder (post hoc) | + (20 vs. 10% placebo) | + | + (29.5 vs. 17.5% placebo) | |
| Safety | Reversible increase in creatinine) | − | LDL cholesterol increase, pruritus in 50% | − | Mild diarrhea and GI side effects |
1
Histology in substudy only; here, effect on NASH and fibrosis.