As the number of people with obesity and diabetes surges, the market for treatments for metabolic dysfunction–associated steatohepatitis (MASH) is growing rapidly. Only two treatments have been approved so far. Against this backdrop, Vanoglipel, a candidate being developed by Metavias, the U.S. subsidiary of Dong-A ST, is drawing industry attention.
MASH is a disease in which fat accumulates in the liver and causes inflammation and damage due to problems in metabolic processes, regardless of alcohol consumption. It can progress to cirrhosis, in which the liver hardens, or liver cancer.
Vanoglipel was originally developed as a diabetes treatment. It was then found to work by a new mechanism that boosts the activity of the key cells that secrete insulin in the pancreas and regulate blood sugar (pancreatic β cells), and stimulates glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP), which lower glucose in the gut. In subsequent animal studies, it showed effects of directly acting on the liver to reduce inflammation and fibrosis, prompting a shift in development toward a MASH treatment.
Metavias is currently developing Vanoglipel as a first-in-class oral drug. In Dec. 2024, it completed a phase 2a trial in presumed MASH patients. The study tested Vanoglipel as a monotherapy and in combination with sitagliptin, a diabetes treatment from Merck (MSD), and both showed positive results.
Blood tests showed a significant decrease in ALT, an indicator of liver damage, and noninvasive tests also showed improvements in liver fat and fibrosis. All key indicators improved, including fatty liver (CAP), liver fibrosis (FAST), and hepatic fat fraction (MRI-PDFF).
At the European Association for the Study of the Liver (EASL Congress 2025) held in the Netherlands in May, results were presented showing dose-dependent reductions in patients with ALT between 40 and 200. In the group that received 100 mg, the average level fell by 22.8. The FAST score decreased from 0.559 to 0.371, improving liver fibrosis, and MRI-PDFF showed a 19.9% reduction in liver fat content.
At the American Association for the Study of Liver Diseases (AASLD) annual meeting on the 7th, additional analyses were released. Among clinical participants, including half without diabetes, glycated hemoglobin (HbA1c), which reflects average blood sugar levels, decreased significantly at week 4 (-0.37%p), week 8 (-0.41%p), and week 16 (-0.54%p). The reductions occurred regardless of weight change, demonstrating a differentiated mechanism from existing MASH treatments.
A Metavias official said, "We confirmed through various data that Vanoglipel improves both liver and metabolic function and could become a new option for treating MASH," and added, "We will continue striving to demonstrate differentiation and competitiveness."