Table 1.
Recently Completed and Ongoing Randomized Controlled Trials for NASH.
| Agents | Mechanisms | Primary Endpoint(s) | Phase Completed | Patients (n) | Duration | Status | NCT |
|---|---|---|---|---|---|---|---|
| GS-0976 | ACC inhibitor | Overall safety | II | 125 | Up to12 weeks plus 30 days | Completed | NCT02856555 |
| Obeticholic acid | FXR agonist | Improvement in liver histology in non-cirrhotic NASH | III | 2500 | 18 months | Recruiting | NCT02548351 |
| Obeticholic acid | FXR agonist | Improvement in fibrosis | III | 540 | 12 months | Recruiting | NCT03439254 |
| GS-9674 | FXR agonist | Overall safety | II | 125 | Up to 24 weeks plus 30 days | Completed | NCT02854605 |
| LMB763 | FXR agonist | Adverse event profile and safety; change in transaminase levels | II | 100 | 12 weeks | Recruiting | NCT02913105 |
| LJN452 | FXR agonist | Adverse event profile; change in transaminase levels and fat in the liver | II | 250 | 12 weeks | Recruiting | NCT02855164 |
| NGM-282 | FGF19 analog | Change in hepatic fat | II | 75 | 24 weeks | Recruiting | NCT02443116 |
| BMS-986036 | FGF 21 analog | Improvement in fibrosis | II | 160 | 24 weeks | Recruiting | NCT03486899 |
| BMS-986036 | FGF 21 analog | Improvement in fibrosis | II | 100 | 48 weeks | Recruiting | NCT03486912 |
| Elafibranor | PPARα/δ agonist | Resolution of NASH without worsening fibrosis | III | 2000 | 72 weeks | Recruiting | NCT02704403 |
| MGL-3196 | THRβ agonist | Change in hepatic fat | II | 117 | 12 weeks | Active, not recruiting | NCT02912260 |
| Aramchol | SCD-1 inhibitor | Change in the hepatic fat | II | 240 | 52 weeks | Completed | NCT02279524 |
| Liraglutide | GLP-1 receptor agonist | Improvement in NASH | III | 36 | 12 months | Recruiting | NCT02654665 |
| Cenicriviroc | CCR2/5 antagonist | Improvement in liver histology | III | 2000 | 12 months | Recruiting | NCT03028740 |
| JKB-121 | TLR4 antagonist | Change in hepatic fat and improvement in ALT | II | 60 | 24 weeks | Completed | NCT02442687 |
| GS-4997 + Simtuzumab | ASK1 inhibitor, LOXL2 inhibitor | Adverse event profile | II | 70 | Up to 28 weeks | Completed | NCT02466516 |
| Selonsertib | ASK1 inhibitor | Improvement in fibrosis without worsening NASH | III | 800 | 48 weeks | Active, not recruiting | NCT03053050 |
| GR-MD-02 | Galectin-3 inhibitor | Improvement in fibrosis | II | 30 | 16 weeks | Completed | NCT02421094 |
| Emricasan | Caspase inhibitor | Improvement in fibrosis without worsening steatohepatitis | II | 330 | 72 weeks | Active, not recruiting | NCT02686762 |
| GS-9450 | Caspase inhibitor | Safety and tolerability | II | 110 | 8 weeks | Completed | NCT00740610 |
ACC, acetyl-CoA carboxylase; FXR, farnesoid X receptor; FGF19, fibroblast growth factor 19; FGF21, fibroblast growth factor 21; PPARα/δ, peroxisome proliferator-activated receptor α/δ; THRβ, thyroid hormone receptor β; LDL-C, low-density lipoprotein cholesterol; SCD1, stearyl coenzyme a desaturase 1; GLP-1, glucagon-like peptide 1; CCR2/5, C-C motif chemokine receptor 2/5; TLR4, toll-like receptor 4; ALT, alanine transaminase; ASK1, apoptosis signal-regulating kinase 1; LOXL 2, lysyl oxidase-like protein 2.