Table 1.

Emerging drugs for non-alcoholic steatohepatitis in phase III trials

Mechanism of action	Drug	Primary endpoint(s)	Clinical trial	Expected completion date
PPAR α/δ agonist	Elafibranor	• Resolution of NASH without worsening of fibrosis	RESOLVE-IT NCT02704403	December 2021
		• Composite endpoint: all-cause mortality, cirrhosis and liver-related clinical outcomes
ASK1 inhibitor	Selonsertib	• ≥1 stage improvement in fibrosis	STELLAR 4	January 2020
		• Event-free survival at 240 weeks	NCT03053063
FXR agonist	Obeticholic acid	• Composite endpoint: all-cause mortality, MELD score ≥15, liver transplant, histological progression to cirrhosis, hepatic decompensation (HCC, ascites, variceal bleed, hepatic encephalopathy, SPB)	REGENERATE NCT02548351	October 2021
		• Fibrosis improvement composite endpoint: improvement in ≥1 stage of fibrosis; NASH resolution with no worsening of fibrosis
CCR2/5 antagonist	Cenicriviroc	• Improvement in ≥1 stage of fibrosis and no worsening of NASH	AURORA NCT03028740	July 2019
		• Clinical outcomes composite endpoint: histological progression to cirrhosis, liver-related clinical outcomes, all-cause mortality

ASK = apoptosis signal-regulating kinase; CCR = cysteine-cysteine motif chemokine receptor; FXR = farnesoid X receptor; MELD = model for end stage liver disease; NASH = non-alcoholic steatohepatitis; PPAR = peroxisome proliferator-activator receptors