Table 1.
Clinical trials evaluating the efficacy of various agents for nonalcoholic steatohepatitis
| Drug | Mechanism | Phase | Trial | Fibrosis stage | Size (n) | Current status |
|---|---|---|---|---|---|---|
| Obeticholic acid | FXR agonist | 3 | REGENERATE (NCT02548351) | NASH fibrosis (F1-3) | 2,480 | Active, not recruiting |
| FDA rejected the new drug application of OCA for pre-cirrhotic NASH | ||||||
| Resmetirom | Selective THR-β agonist | 3 | MAESTRO-NASH (NCT03900429) | NASH fibrosis (F2-3) | 2,000 | Ongoing |
| Semaglutide | GLP-1 RA | 3 | ESSENCE (NCT04822181) | NASH fibrosis (F2-3) | 1,200 | Ongoing |
| Dapagliflozin | SGLT2 inhibitor | 3 | DEAN (NCT03723252) | NASH | 100 | Ongoing |
| Aramchol | SCD1 inhibitor | 3 | ARMOR (NCT04104321) | NASH fibrosis (F2-3) | 2,000 | Part I (open-label) met its objective |
| Part II (double-blind) was suspended | ||||||
| Lanifibranor | Pan-PPAR agonist | 3 | NATiV3 (NCT04849728) | NASH fibrosis (F2-3) | 2,000 | Ongoing |
| Pegozafermin | FGF21 agonist | 2 | ENLIVEN (NCT04929483) | NASH fibrosis (F2-3) | 222 | Completed |
| Fibrosis significantly improved ≥1 stage without worsening of NASH |
FDA, US Food and Drug Administration; OCA, obeticholic acid; GIP, glucose-dependent insulinotropic polypeptide; GLP-1 RA, glucagone-like peptide-1 receptor agonists; FGF, fibroblast growth factor; FXR, farnesoid X receptor; NASH, nonalcoholic steatohepatitis; PPAR, peroxisome proliferator-activated receptor; SCD, stearoyl coenzyme A desaturase; SGLT, sodium-glucose cotransporter; THR, thyroid hormone receptor.