Table 2.
Other Therapies in Phase 3 Clinical Trials for NASH (Clinicaltrials.gov)
| Trial | Phase | Drug | Mechanism | Primary Outcome | Expected Completion |
|---|---|---|---|---|---|
| REGENERATE | Phase 3 | Obeticholic acid | FXR agonist | -Improvement in fibrosis by ≥ 1 stage with no worsening NASH -NASH resolution with no worsening of fibrosis -All cause mortality and liver related events |
Oct 2022 |
| RESOLVE IT | Phase 3 | Elafibranor | PPAR α/δ agonist | -NASH resolution without worsening of fibrosis -All cause mortality, cirrhosis, liver related clinical outcomes |
Dec 2021 |
| MONARCh | Phase 3 | MSDC 0602K | Mitochondrial pyruvate carrier inhibitor | -Change in HbA1c -Histological resolution of NASH |
Dec 2021 |
| MAESTRO-NASH | Phase 3 | Resmetirom | Thyroid hormone receptor β agonist | -NASH resolution on histology -All cause mortality, cirrhosis, liver related clinical outcomes |
March 2024 |
| ARMOR | Phase 3 | Aramchol | SCD-1 modulator | Resolution of NASH or improvement in fibrosis by 1 stage and no worsening of NASH | Dec 2024 |
Abbreviations: FXR, farnesoid X receptor; NASH, non-alcoholic steatohepatitis; PPAR, peroxisome proliferator-activated receptor; SCD, stearoyl-CoA desaturase 1.