Table 1

Clinical trials of medications for non-alcoholic fatty liver disease (NAFLD)

MedicationMechanismCurrent statusHistological benefit shownStudied in cirrhoticsStudied in diabetics with NAFLD
Medications with a primary metabolic target
 PioglitazonePPARγ agonistPhase III concluded*Yes (secondary analyses only)NoNo
 ElafibranorPPARα/δ agonistPhase IIIYes (secondary analyses only)NoYes
 SaroglitazarPPARα/γ agonistPhase III*Pending†YesYes
 Obeticholic acidFXR agonistPhase III*YesNoYes
 LiraglutideGLP-1 receptor agonistPhase II concluded*YesYesYes
 AramcholSCD inhibitorPhase IIbPending†NoYes
 Volixibat (SHP-626)ASBT inhibitorPhase IIPending†NoYes
 BMS-986036FGF-21 analoguePhase IINot studied?Yes
 NGM-282FGF-19 analoguePhase IINot studied??
 TesamorelinGHRH analoguePhase II* (HIV patients)Pending†NoYes
 NDI-010976ACC inhibitorPhase I concludedNot studiedNoNo
 GS-9674FXR agonistPhase INot studiedNoNo
 Dur-928Sulfated oxysterolPhase INot studiedYesYes
 AZD4076miR-103/107 antagonistPhase INot studiedNoNo
 RosuvastatinHMG-CoA reductase inhibitorUncontrolled pilot concluded*YesNoNo
 INT-767FXR/TGR5 agonistPreclinical
 SevelamerBile acid sequestrantPreclinical*
Medications targeting oxidative stress and inflammation
 Vitamin EAntioxidantPhase III‡YesNoNo
 PentoxifyllinePDE inhibitorPhase II concludedYesNoYes
 CenicrivirocCCR2/CCR5 antagonistPhase IIbPending†NoYes
 EmricasanCaspase inhibitorsPhase IIbPending†NoYes
 GS-4997ASK1 inhibitorPhase IIPending†NoYes
 AmlexanoxIKKε/TBK1 inhibitorPhase II*Not studiedNoYes
 PXS-4728AVAP-1 inhibitorPhase I concludedNot studiedNoNo
Medications targeting the gut
 OrlistatIntestinal lipase inhibitorPhase II concluded*InconclusiveYesYes
 IMM-124eIgG-rich bovine colostrumPhase IINot studiedNoYes
 SolithromycinAntibioticPhase IIPending†NoYes
 Faecal microbial transplantModulation of gut microbiomePilotNot studiedNoYes
Antifibrotics
 SimtuzumabLOXL2 antibodyPhase IIPending§YesYes
 GR-MD-02Galectin-3 inhibitorPhase IIPending§YesYes
  • *Currently approved for non-NAFLD indication.

  • †Histological outcome is studied in an ongoing trial.

  • ‡Currently available over the counter.

  • §Histological and portal pressure outcomes are studied in an ongoing trial.

  • ACC, acetyl-CoA carboxylase; ASBT, apical sodium-dependent bile acid transporter; GLP, glucagon-like peptide; FGF, fibroblast growth factor; FXR, farnesoid X receptor; GHRH, growth hormone-releasing hormone; HMG-CoA, 3-hydroxy-3-methyl-glutaryl-coenzyme A; LOXL2, lysyl oxidase-like; PDE, phosphodiesterase; PPAR, peroxisome proliferator-activator receptor; SCD, stearoyl CoA desaturase; VAP, vascular adhesion protein.