Emerging treatment options for metabolic dysfunction-associated steatotic liver disease and its related liver diseases

Table 1 Treatment of metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis in clinical trials

Clinical trials	Phase	Treatments	Effects	Ref.
NCT05006885	1	Pemvidutide (also known as ALT-801), a GLP-1/glucagon dual receptor agonist	Reduction in body weight Reduction in ALT levels Decrease in liver corrected T1	[65]
NCT05090111	1	ALG-055009, an oral THR-β agonist	Decrease in atherogenic lipids in a dose-dependent manner. Increase in sex hormone-binding globulin	[66]
NCT06491576	1/2	BGT-002, an ATP-citrate lyase inhibitor	Reduction in circulating GGT levels	[68]
NCT04202354	1/2	GSK4532990 (ARO-HSD), an RNA interference targeting HSD17β13 mRNA in hepatocytes	Reduction in hepatic HSD17β13 mRNA and protein expression, as well as alanine aminotransferase	[69]
NCT05989711	2	Pemvidutide	Improvement in MASH resolution, without worsening liver fibrosis	[70]
NCT04166773	2	Tirzepatide, a dual GLP-1 and GIP receptor agonist	Reduction in body weight, HbA1c, with improvement of liver fibrosis	[72]
NCT04771273	2	Survodutide, a dual agonist of glucagon receptor and GLP-1 receptor	Improvement in MASH resolution without worsening of fibrosis	[73]
NCT04881760	2	Retatrutide, a novel triple agonist of the GIP, GLP-1, and glucagon receptors	A reduction in liver fat compared to placebo in a dose-dependent manner	[74]
NCT03656744	2	Berberine ursodeoxycholate (HTD1801), an ionic salt of berberine and ursodeoxycholic acid	Improved glycemic control and reduced body weight, liver fat content, and serum ALT and GGT levels	[76]
NCT02413372 NCT04929483	2	Pegbelfermin (BMS-986036), a PEGylated human FGF21 analogue	Decrease in hepatic fat fraction Improvement in liver fibrosis	[77,78]
NCT04210245	2	Aldafermin, an engineered human hormone FGF19 analogue	Reduction in liver fibrosis	[79]
NCT03459079	2	Lanifibranor, a pan-peroxisome proliferator-activated receptor agonist	Improvement in liver inflammation and fibrosis. Decrease hepatic fat accumulation	[80]
NCT04906421	2	Denifanstat, an oral fatty acid synthase inhibitor	Improvement in MASLD activity score without worsening fibrosis. Improvement in MASH resolution	[81]
CTRI/2023/08/0559821	3	24-norursodeoxycholic acid	Reduction in ALT levels. Improvement in liver fibrosis and stiffness	[83]
NCT03723252	3	Dapagliflozin, a SGLT inhibitor	Improvement in fibrosis and MASH resolution	[85]
NCT05647915	4	Berberine plus lifestyle intervention	Decrease in LDL cholesterol, apolipoprotein B, and hs-CRP levels	[88]

¹Clinical Trials Registry-India.

ALT: Alanine aminotransferase; FGF: Fibroblast growth factor; GGT: Gamma-glutamyl transferase; GGT: Gamma-glutamyl transferase; GIP: Glucose-dependent insulinotropic polypeptide; GLP-1: Glucagon-like peptide-1; hs-CRP: High-sensitivity C-reactive protein; HSD17β13: Hydroxysteroid 17-beta dehydrogenase 13; LDL: Low-density lipoprotein; SGLT2: Sodium-glucose co-transporter 2; THR-β: Thyroid hormone receptor beta; MASLD: Metabolic dysfunction-associated steatotic liver disease; MASH: Metabolic dysfunction-associated steatohepatitis.