MetaVia Presents Positive New Phase 2a Data on Vanoglipel (DA-1241) in Patients with Presumed MASH at the AASLD The Liver Meeting® 2025

Core Insights - MetaVia Inc. announced positive results from its Phase 2a clinical trial of vanoglipel (DA-1241), a GPR119 agonist, showing significant improvements in glucose control, liver health, and plasma lipid profiles in patients with metabolic dysfunction-associated steatohepatitis (MASH) [1][3][9] Clinical Trial Details - The Phase 2a trial was randomized and placebo-controlled, involving 109 subjects with presumed MASH, who received either placebo, vanoglipel 50 mg, vanoglipel 100 mg alone, or vanoglipel 100 mg with a DPP4 inhibitor for 16 weeks [2][4] - Vanoglipel demonstrated rapid and sustained improvements in glycemic control, with mean HbA1c reductions of -0.54% with monotherapy and -0.66% with combination therapy at Week 16 [3][4] Mechanism of Action - Vanoglipel acts as a GPR119 agonist, stimulating GLP-1 secretion, which enhances glucose metabolism and lipid profiles [2][9] - The treatment showed significant reductions in plasma ALT levels and improvements in liver steatosis and stiffness, indicating hepatoprotective effects [4][5] Biomarker Improvements - Treatment with vanoglipel resulted in decreased biomarkers associated with cell death, inflammation, and fibrosis, supporting its hepatoprotective mechanism [5] - Favorable changes in plasma lipidomic profiles were observed, including reductions in disease-associated glycerolipids and glycerophospholipids [5] Tolerability and Safety - Vanoglipel was well tolerated across all treatment groups, with no treatment-emergent adverse events leading to discontinuation, except for one in the placebo group [6] Company Overview - MetaVia Inc. is focused on developing therapies for cardiometabolic diseases, with vanoglipel being a key candidate for treating MASH and type 2 diabetes [10][12]