Table 1.

Summary of pharmacotherapeutic candidates in phase III trials for NASH treatment.

Medication	Mechanism of action	Trial status	Name of phase III RCT	Enrollment participants & duration	Inclusion criteria
Obeticholic acid (Intercept)	FXR agonist	Interim completed	REGENERATE (NCT02548351)	2480 participants, 18 months	NASH with fibrosis
			REVERSE (NCT03439254)	919 participants, 12 months	NASH with compensated cirrhosis
Resmetirom (Madrigal)	THRβ agonist	On-going	MAESTRO-NASH (NCT03900429)	2000 participants, 52 weeks	Non-cirrhotic NASH with fibrosis (F2–F3)
			MAESTRO-NAFLD1 (NCT04197479)	700 participants, 52 weeks	NAFLD/NASH
Lanifibranor (Inventiva)	Pan-PPAR agonist	On-going	NATiV3 (NCT04849728)	2000 participants, 72 weeks	Non-cirrhotic NASH with fibrosis (F2–F3)
Aramchol (Galmed)	SCD1 inhibitor	On-going	ARMOR (NCT04104321)	2000 participants, 72 weeks	Non-cirrhotic NASH with fibrosis (F2–F3)
Semaglutide (Novo Nordisk)	GLP1 agonist	On-going	NCT04822181	1200 participants, 72 weeks	Non-cirrhotic NASH with fibrosis (F2–F3)
Belapectin (Galectin)	Galectin 3 inhibitor	On-going	NAVIGATE (NCT04365868)	1010 participants, 78 weeks	NASH cirrhosis and portal hypertension without esophageal varices
Dapagliflozin (Nanfang Hospital Southern Medicine University)	Sodium-glucose cotransporter 2 (SGLT2) inhibitor	On-going	DEAN (NCT03723252)	100 participants, 12 months	NASH with stable glycemic control (HbA1c < 9.5%)
Oltipraz (PharmaKing)	AMPK activators	On-going	NCT04142749	144 participants 24 weeks	NAFLD except for liver cirrhosis
Cenicriviroc (Allergan)	CCR2/5 antagonists	Terminated	AURORA (NCT03028740)	1779 participants, 12 months	NASH with fibrosis
Elafibranor (GENFIT)	PPARα/σ agonist	Terminated	RESOLVE-IT (NCT02704403)	2157 participants, 72 weeks	NASH with fibrosis
Selonsertib (Gilead)	ASK1 inhibitor	Terminated	STELLAR-3 (NCT03053050)	808 participants, 48 weeks	NASH with bridging (F3) fibrosis
			STELLAR-4 (NCT03053063)	883 participants, 48 weeks	NASH with compensated cirrhosis

AMPK AMP-activated protein kinase, HbA1c Glycated hemoglobin A1c, CCR C-C chemokine receptor, ASK1 apoptosis signal-regulating kinase 1.