Table 1

Trials of combination therapies currently ongoing for the treatment of non-alcoholic steatohepatitis (NASH)

Name/numberFirst drugSecond drugArmsPopulationDuration, weeksEndpointsSecondary endpoints
CONTROL
Phase 2
NCT02633956
Obeticholic acidAtorvastatinPlacebo, 5, 10, 25 mg Obeticholic acid with atorvastatin 10, 20 mgNASH F1–F3
F4 No decompensation
16LDL cholesterolSafety, tolerability, lipoproteins
TANDEM
Phase 2
NCT03517540
TropifexorCenicrivirocTropifexor dose 1
Cenicriviroc
Tropifexor dose 1+cvc
Tropifexor dose 2+cvc
NASH F2/348AEOne-stage improvement in fibrosis
Resolution of NASH
ELIVATE
Phase 2
NCT04065841
TropifexorLicoglifozinTropifexor
Licogliflozin
Tropifexor +licogliflozin
NASH F2/F348Resolution of NASH and no worsening of fibrosis
OR improvement in fibrosis by at least one stage without worsening of NASH
Improvement of fibrosis by two stages, reduction in body weight, change in liver fat content on MRI-PDFF, improvement of liver tests
Proof-of-concept study
NCT02781584
CilofexorFirsocostat
Selonsertib
Selonsertib
Firsocostat
Cilofexor
Cilo+Sel
Sel+Firso
Cilo+Firso
Firso cirrhotics
Cilo cirrhotics
Cilo+Sel + Firso
Firso+Feno 48
Firso +Feno145
NASH F2/3 some F412TEAEs
TESAEs
TELAs
ATLAS
Phase 2
NCT03449446
CilofexorFirsocostat
Selonsertib
Sel+Firso + placebo
Sel+Cilo + placebo
Sel+placebo + placebo
Firso +placebo + placebo
Cilo+placebo + placebo
3 placebos
Firso+Cilo + placebo
NASH F3/448AEs
TELA
One-stage improvement in fibrosis without worsening NASH
Phase 2
NCT03987074
CilofexorSemaglutide
Firsocostat
Semaglutide
Firso+Sema
Sema+Cilo 30
Sema+Cilo 100
Sema+Firso + Cilo
NASH F2/324TEAEs
TESAEs
TELA
Phase 2A
NCT03776175
PF-05221304, ACC inhibitorPF-06865571, DGAT2
Inhibitor
PF-05221304
PF-06865571
Placebo
PF-05221304 +
PF-06865571
NAFLD6Steatosis (MRI-PDFF)Safety, tolerability
  • ACC, acetyl-CoA carboxylase; AEs, adverse events; Cilo, cilofexor; CVC, cenicriviroc; DGAT2, diacylglycerol acyltransferase 2; Firso, firsocostat; LDL, low-density lipoprotein; MRI-PDFF, MRI proton density fat fraction; NAFLD, non-alcoholic steatohepatitis; Sel, selonsertib; Sema, semaglutide; TEAEs, treatment-emergent adverse events; TELAs, treatment-emergent laboratory abnormalities; TESAEs, treatment-emergent serious adverse events.