Non-alcoholic fatty liver disease: Immunological mechanisms and current treatments

Table 1 Current active and recruiting clinical trials assessing therapeutics for non-alcoholic fatty liver disease

Drug name	Condition	Target	Clinical trial Number	Phase	Status	Primary endpoint
GH509	NASH NAFLD		NCT05784779	Phase Ib/II	Recruiting	Change in liver fat content assessed by MRI-PDFF
LUM-201	NASH NAFLD	Lipid accumulation	NCT05364684	Phase II	Recruiting	Change in intrahepatic lipid content measured by proton magnetic resonance spectroscopy
Choline	NAFLD	Choline deficiency	NCT05200156	N/A	Recruiting	Change in Thiobarbituric acid reactive substances serum level
Dasatinib and quercetin	Fibrosis	Senescence	NCT05506488	Phase I	Recruiting	Improvement of fibrosis NAFLD score based on histology after 21 wk
GSK4532990	NAFLD fibrosis	17 β-HSD	NCT05583344	Phase II	Recruiting	Improvement of fibrosis measured by clinical research network scoring
Lisinopril	NASH HCC	ACE inhibitor	NCT04550481	Phase II	Recruiting	Changes in fibrosis marker PRO-C3
Rencofilstat	NASH Fibrosis NAFLD	Cyclophilin inhibitor	NCT05402371	Phase II	Recruiting	Improvement in fibrosis score CRN or NASH resolution
Lactobacillus reuteri GMNL-263 and GMNL-89 and lactobacillus rhamnosus GMNL-74	NAFLD	Gut microbiome	NCT05402449	N/A	Recruiting	Changes in serum ALT levels
Lubiprostone	NAFLD	Type 2 chloride channel activator	NCT05768334	Phase III	Recruiting	Changes in liver fat by measured by MRI-PDFF
Bacillus coagulans TCI711	NAFLD	Gut microbiome	NCT05635474	N/A	Recruiting	Changes measured by fibroscan
TVB-2640	NAFLD	FASN inhibitor	NCT04906421	Phase III	Active, not recruiting	Improvement in NAS and CRN scoring
ASC41	NASH NAFLD	THRβ agonist	NCT05462353	Phase II	Recruiting	Improvement in NAS score
Ketohexokinase inhibition	NAFLD	Ketohexokinase	NCT05463575	Phase II	Recruiting	Insulin-mediated suppression of endogenous glucose production
PF-06865571/ PF-05221304	NAFLD NASH with fibrosis	DGAT2 inhibitor/ACC inhibitor	NCT04321031	Phase II	Active, not recruiting	Resolution of NASH
ZED1227	NAFLD fibrosis	TG2 inhibitor	NCT05305599	Phase II	Recruiting	Relative change of serum PRO-C3 levels
MK-3655	NASH	FGF21 agonist	NCT04583423	Phase II	Active, not recruiting	Resolution of NASH
MXP22 (probiotic and antioxidant capsule)	NAFLD	Gut microbiome	NCT05808049	N/A	Recruiting	Changes in steatosis measure by fibroscan
TERN 501/TERN-101	NASH	THRβ agonist/ FXR agonist	NCT05415722	Phase II	Active, not recruiting	Relative change in liver fat content (MRI-PDFF)
MET642	NASH	FXR agonist	NCT04773964	Phase II	Active, not recruiting	Safety study to measure adverse events
VK2809	NASH	THRβ agonist	NCT04173065	Phase II	Recruiting	Relative change in liver fat content (MRI-PDFF)

MRI-PDFF: Magnetic resonance imaging-estimated proton density fat fraction; NASH: Non-alcoholic steatohepatitis; FXR: Farnesoid X receptor; NAFLD: Non-alcoholic fatty liver disease; THRβ: Thyroid hormone receptor-β; NAS: Non-alcoholic fatty liver disease activity score; HCC: Hepatocellular carcinoma; ALT: Alanine aminotransferase; FASN: Fatty acid synthase; HSD: High-salt diet; CRN: Clinical research network; N/A: Not applicable.