TABLE 2.
Inflammation-targeted pharmacologic agents that have completed or are undergoing clinical trials for NASH.
| Mechanism of action | Agent name | Company(s) | Trial phase | Primary endpoint(s) | Primary completion | Clinical trial ID |
|---|---|---|---|---|---|---|
| CCR2/5 inhibitor | Cenicriviroc | Allergan | 3 | 1. Improvement in fibrosis without worsening steatohepatitis; 2. Long-term clinical outcomes | Oct 2021 | NCT03028740 |
| ASK1 inhibitor | Selonsertib | Gilead | 3 | 1. Improvement in fibrosis without worsening of NASH; 2. Event-free survival | Jun 2019 | NCT03053050 |
| 3 | 1. Improvement in fibrosis without worsening of NASH; 2. Event-free survival | May 2019 | NCT03053063 | |||
| Pan-caspase inhibitor | Emricasan | Novartis/Conatus pharmaceuticals | 2 | Improvement in fibrosis without worsening of steatohepatitis | Jan 2019 | NCT02686762 |
| 2 | Improvement in event-free survival based on a composite clinical endpoint | Aug 2019 | NCT03205345 | |||
| TLR-4 antagonist | JKB-121 | TaiwanJ | 2 | Change from baseline in hepatic fat | Sept 2017 | NCT02442687 |
| JKB-122 | TaiwanJ | 2 | 1. Reduction in NAS without worsening of fibrosis; 2. Improvement in fibrosis without worsening of NAS | Jun 2023 | NCT04255069 | |
| Mineralocorticoid receptor antagonist | MT-3995 | Mitsubishi tanabe pharma | 2 | Percent change from baseline in ALT | Mar 2018 | NCT02923154 |
| VAP-1 inhibitor | BI-1467335 | Boehringer ingelheim | 2 | Target enzyme activity relative to baseline in percent | Jun 2019 | NCT03166735 |
| TERN-201 | Terns pharmaceuticals | 1 | Safety and tolerability |
ALT, alanine aminotransferase; ASK1, apoptosis signal-regulating kinase 1; CCR2/5, C-C motif chemokine receptor 2/5; NAS, non-alcoholic fatty liver disease activity score; NASH, non-alcoholic steatohepatitis; TLR-4, toll-like receptor-4; VAP-1, vascular adhesion protein-1.