MetaVia Inc. Secures IRB Approval for Higher-Dose Phase 1 Studies of DA-1726, Advancing GLP-1-Based Obesity Program

Key Highlights

• Institutional Review Board (IRB) Approval: MetaVia Inc. (Nasdaq: MTVA) has received IRB approval for Part 3 of its Phase 1 clinical trial for DA-1726, a novel dual agonist targeting both GLP-1 and glucagon receptors.
• Upcoming Dose-Escalation Study: The approved trial will evaluate higher target doses—up to 64 mg—of DA-1726 using one-step and two-step titration strategies in obese, otherwise healthy adults.
• Potential Best-in-Class Asset: DA-1726 has demonstrated approximately 9% weight loss, improved glycemic control, and early signs of liver benefit in earlier cohorts, with an encouraging safety profile.
• Data Readout Timeline: Initial dosing is expected in April 2026, with topline data anticipated in Q4 2026.

Detailed Report

MetaVia Inc., a clinical-stage biotechnology company specializing in cardiometabolic diseases, announced a significant advancement in its lead obesity program. The company has secured IRB approval from Clinical Pharmacology of Miami, enabling it to initiate Part 3 of its Phase 1 clinical trial for DA-1726—a dual oxyntomodulin (OXM) analog designed to activate both GLP-1 (GLP1R) and glucagon (GCGR) receptors.

Study Design and Objectives

The upcoming study will enroll 40 obese but otherwise healthy adult participants, split into two cohorts of 20. Each cohort will be randomized in a 4:1 ratio (16 on active drug, 4 on placebo). The key difference between the cohorts is the titration approach:

• Part 3A (One-step titration): 16 mg for four weeks, escalating directly to 48 mg for twelve weeks.
• Part 3B (Two-step titration): 16 mg for four weeks, then 32 mg for four weeks, and finally 64 mg for eight weeks.

The primary endpoints are focused on safety and tolerability, including the incidence of adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and discontinuations due to AEs. Secondary and exploratory endpoints include pharmacokinetic (PK) profiling, metabolic and glycemic measures, lipid profiles, and comprehensive body composition metrics such as weight, waist circumference, and BMI.

Clinical and Investor Significance

This development is potentially price-sensitive for several reasons:

• Faster Titration and Higher Doses: If successful, DA-1726 could achieve full therapeutic dosing more rapidly than currently marketed GLP-1 therapies, many of which require slower, prolonged titration. This represents a potential competitive advantage in the obesity market.
• Early Efficacy Signals: Previous study cohorts showed that the 48 mg dose of DA-1726 produced about 9% weight loss over 16 weeks, reductions in waist circumference, improved blood sugar control, and early signs of liver health benefits—all with a favorable safety profile. These results, if confirmed and improved at higher doses, could support DA-1726 as a differentiated, next-generation obesity and metabolic disease therapy.
• Upcoming Catalysts: Data from the new higher-dose cohorts are expected in Q4 2026. A positive readout could de-risk the program further, potentially driving significant investor interest and affecting MetaVia’s share price.
• Pipeline Synergy: MetaVia is also advancing vanoglipel (DA-1241), a GPR119 agonist for Metabolic Dysfunction-Associated Steatohepatitis (MASH), showing broad activity across hepatic inflammation, lipid metabolism, and glucose control. This positions the company as a multi-asset player in high-value metabolic indications.

Mechanistic and Competitive Insights

DA-1726 is a once-weekly subcutaneous injectable, acting as a dual GLP-1/glucagon receptor agonist. In preclinical models, it produced superior weight loss compared to semaglutide (Wegovy®) and matched tirzepatide (Zepbound®) and survodutide in weight reduction, but with the added benefits of greater food intake and preservation of lean body mass. The drug also improved lipid profiles compared to survodutide. In prior Phase 1 studies, the 32 mg dose demonstrated best-in-class potential across weight, glucose, and waist circumference reduction.

Risks and Forward-Looking Statements

Investors should note that MetaVia has a history of net losses and will require additional capital to fund operations. The outcome of the DA-1726 program depends on successful trial execution, regulatory approvals, and the ability to differentiate from competitors. Other risks include reliance on third parties for manufacturing and trials, as well as external economic and regulatory conditions. All forward-looking statements are subject to risks described in MetaVia’s SEC filings.

Contact Information

MetaVia Inc.: Marshall H. Woodworth, Chief Financial Officer, +1-857-299-1033, [email protected]
Investor Relations: Michael Miller, Rx Communications Group, +1-917-633-6086, [email protected]

Disclaimer: This article contains forward-looking statements based on currently available information and management’s expectations. Actual results may differ due to various risks and uncertainties. Investors should consult the company’s most recent filings with the Securities and Exchange Commission and not rely solely on this article for investment decisions.

View MetaVia Inc. Historical chart here