TABLE 2.
Clinical trials with use of combination therapies in patients with NAFLD and NASH
| Drugs | Target | Indication | Clinical trial name | Primary outcome(s) | Current status |
|---|---|---|---|---|---|
| Saroglitazar+vitamin E | PPAR-γ Antioxidant | NAFLD | NCT04193982 | Change in NAFL fibrosis score | Phase 3: Recruiting |
| PF-06865571+PF-05221304 | DGAT2 ACC | NAFLD | NCT04399538 | Change in liver fat content | Phase 2: Recruiting |
| MET-409 +empaglifozin | FXR SGLT2 | NASH | NCT04702490 | Safety and tolerability of MET-409 | Phase 2: Active not yet recruiting |
| Tropifexor+licoglifozin | FXR SGLT2 | ELIVATE NASH F2-F3 | NCT04065841 | Improvement in fibrosis without worsening of NASH NASH resolution without fibrosis worsening |
Phase 2: Recruiting |
| Semaglutide+cilofexor +firscostat | GLP-1 FXR+ACC | NASH cirrhosis | NCT04971785 | Improvement in fibrosis without worsening of NASH NASH resolution without fibrosis worsening |
Phase 2: Recruiting |
| Tropifexor +cenicriviroc | FXR Chemokine receptor 2/5 | NASH F2-F3 | TANDEM NCT03517540 | Safety of combination | Phase 2: Completed and results awaited |
| Cilofexor+firscostat +selonsertib | FXR ACC+ASK-1 | NASH F3-F4 | ATLAS NCT03449446 | Adverse effects and safety of combination | Phase 2: Completed and results awaited |
Abbreviations: ACC, acetyl-CoA carboxylase; ASK-1, apoptosis signal-regulating kinase 1; DGAT2, diacylglycerol acyltransferase-2; FXR, farnesoid X receptor; GLP-1, glucagon-like peptide 1; PPAR, peroxisome proliferator-activated receptor; SGLT2, sodium-glucose co-transporter type 2.