MetaVia Unveils Breakthrough Phase 2a Findings on Vanoglipel
Oral GPR119 Agonist Shows Significant Health Benefits for Patients
MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company specializing in treatments for cardiometabolic diseases, presented remarkable data from the Phase 2a clinical trial of vanoglipel (DA-1241) at a recent major liver health conference. Vanoglipel, a selective G protein-coupled receptor 119 (GPR119) agonist, has demonstrated impactful results in treating metabolic dysfunction-associated steatohepatitis (MASH). The trial's findings reveal vanoglipel's ability to not only improve liver inflammation and fibrosis but also support better glucose management and favorable changes in lipid profiles after 16 weeks of treatment.
This well-structured Phase 2a trial was randomized and placebo-controlled, assessing vanoglipel both alone and in conjunction with a dipeptidyl peptidase-4 inhibitor (DPP4i). The aim was to observe its potential in enhancing the body's response to GLP-1. A total of 109 participants with presumed MASH took part in the trial, receiving either a placebo, vanoglipel 50 mg, vanoglipel 100 mg by itself, or vanoglipel 100 mg alongside a DPP4 inhibitor. This rigorous approach ensured valid comparisons of the results.
Hyung Heon Kim, President and Chief Executive Officer of MetaVia, remarked, "These encouraging results highlight vanoglipel's ability to improve both metabolic and liver health factors in one oral treatment. The data illustrates reductions in HbA1c among type 2 diabetes and prediabetes patients, along with beneficial shifts in lipid profiles, signaling vanoglipel's potential in managing MASH effectively. After extensive treatment, consistent improvement in health markers was noted, emphasizing its dual action as a monotherapy and in combinations for MASH and related metabolic ailments.”
The trial showcased impressive improvements in glycemic control, highlighted by a significant reduction in HbA1c from as early as week four. At the conclusion of the 16-week treatment, patients receiving vanoglipel as monotherapy had a mean HbA1c reduction of –0.54%, while those in the combination group saw decreases of –0.66%. Even with a significant number of non-diabetic participants, these changes were statistically significant, underscoring vanoglipel’s distinct mechanism of action in enhancing glucose control that is not dependent on weight loss.
Moreover, vanoglipel brought about significant improvements in liver health markers, particularly in lowering plasma alanine transaminase (ALT) levels for subjects with elevated baseline ALT. The data suggested that vanoglipel largely drives hepatoprotective effects independently, further emphasizing its potential as a standalone treatment option. Non-invasive measures of liver health also reflected favorable changes, reinforcing vanoglipel's capability to address the metabolic dysfunction linked to MASH.
The positive effects of vanoglipel extended to reducing biomarkers associated with liver damage and inflammation. Notably, decreased established markers like CK18F/M30 were recorded alongside reductions in hs-CRP and TIMP1, further highlighting the drug's multifaceted benefits. Additionally, significant changes in lipid profiles were observed, indicating the possibility of beneficial metabolic remodeling.
Unsurprisingly, the treatment was generally well tolerated among participants, with minimal reports of adverse events that led to discontinuation, thus confirming the safety profile of this innovative therapy.
Presentation Highlights:
- Title: Vanoglipel (DA-1241) Demonstrates Hepatoprotective Effects Through Improving Inflammation and Metabolism: A 16-week Placebo-Controlled Trial
- Presenting Author: Rohit Loomba, M.D., MHSc, at UC San Diego
- Poster Number: 4012
- Session: Monday Poster Presenters Hall Hour
- Poster Date: November 10, 2025
- Poster Time: 1:00-2:00 PM ET
- Poster Location: Convention Center: Hall DE, Level 2
About Vanoglipel (DA-1241)
Vanoglipel (DA-1241) stands out as a promising GPR119 agonist aimed at providing therapeutic options for both MASH and type 2 diabetes. By stimulating GPR119 in the gut, the drug encourages the release of vital gut peptides that are crucial for glucose and lipid metabolism. Early studies reflect its positive impacts on liver health while simultaneously supporting glucose management. In trials, vanoglipel has shown benefits in reducing liver fat, inflammation, and fibrosis.
About MetaVia
MetaVia Inc. is committed to transforming treatments for cardiometabolic diseases. The company's focus extends to developing novel therapies like DA-1726 for obesity and vanoglipel for MASH. With cutting-edge research, MetaVia aims to innovate treatment strategies that enhance patient health outcomes effectively.
For further information, visit www.metaviatx.com.
Contacts:
MetaVia
Marshall H. Woodworth
Chief Financial Officer
+1-857-299-1033
Rx Communications Group
Michael Miller
+1-917-633-6086
Frequently Asked Questions
What is vanoglipel?
Vanoglipel (DA-1241) is a GPR119 agonist aimed at treating MASH and type 2 diabetes.
What did the Phase 2a trial show?
The trial demonstrated significant improvements in liver inflammation, fibrosis, and glucose control after treatment with vanoglipel.
How long was the treatment duration in the trial?
The treatment lasted for 16 weeks, during which participants were monitored for health improvements.
Was vanoglipel well tolerated by patients?
Yes, the treatment was well tolerated, with minimal adverse events reported.
What future developments can we expect from MetaVia?
MetaVia is focusing on further research and development of vanoglipel along with other innovative therapies for cardiometabolic diseases.
