New drug therapies for metabolic dysfunction-associated steatohepatitis

Jul 7, 2025Liver research (Beijing, China)

New drug treatments for fatty liver disease linked to metabolism problems

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Abstract

The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) has reached 30% globally.

MASLD ranges from simple fat accumulation in the liver to more severe forms like metabolic dysfunction-associated steatohepatitis (MASH), which can lead to fibrosis, cirrhosis, and liver cancer.
Common symptoms of MASLD include high levels of fats in the blood, elevated blood sugar, insulin resistance, and obesity.
Current treatment options for MASH with fibrosis are limited, and existing bile acid and FXR-based drugs have shown moderate effectiveness and unwanted side effects.
Recently, resmetirom has been approved specifically for MASH fibrosis, while glucagon-like peptide-1 receptor agonists are under investigation.
No bile acid or FXR-based drugs have received approval from the US Food and Drug Administration for treating MASH fibrosis.

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The prevalence of metabolic dysfunction-associated steatotic liver disease (MASLD) has rapidly increased world-wide to 30%, with increasing of type 2 diabetes (T2D) and obesity in last two decades. The spectrum of MASLD covers from simple hepatic steatosis to the progressive metabolic dysfunction-associated steatohepatitis (MASH) with or without fibrosis, cirrhosis and hepatocellular carcinoma. The MASLD symptoms include dyslipidemia, hyperglycemia, insulin resistance and obesity, the liver manifestations of metabolic syndrome. Treatment option for MASH fibrosis is limited. Since the discovery of bile acids as the endogenous ligands of farnesoid X receptor (FXR) in early 1990, bile acid and FXR based-drug therapies have been developed and tested in clinical trials for cholestatic liver diseases and MASH fibrosis. However, many of these drugs have unwanted side-effects and moderate efficacy in improving fibrosis. The US Food and Drug Administration has not approved any of bile acid- and FXR-based drugs for MASH fibrosis. Drug therapies alternative to bile acid derivatives for MASH have been in clinical trials. Recently, resmetirom, a liver-specific- and thyroid hormone receptor beta-selective agonist has been approved for MASH fibrosis. Glucagon-like peptide-1 receptor agonists also are in clinical trials for MASH. This review covers recent development of novel drug therapies for MASH fibrosis, T2D and obesity.

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New drug therapies for metabolic dysfunction-associated steatohepatitis

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