MetaVia Extends DA-1726 Phase 1 Clinical Trial to 8 Weeks and Announces Fifth Dose in First Patient.

MetaVia has extended its Phase 1 clinical trial of DA-1726 for obesity treatment to 8 weeks from 4 weeks. The extension aims to assess early efficacy and patient safety with longer-term exposure to DA-1726 and further explore the non-titrated maximum tolerated dose. Top-line data is expected in Q4 2025.

MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, has extended its Phase 1 clinical trial of DA-1726 for the treatment of obesity to 8 weeks from 4 weeks. The extension is designed to assess early efficacy and patient safety with longer-term exposure to DA-1726 and further explore the non-titrated maximum tolerated dose. Top-line data is expected in the fourth quarter of 2025.

The 48 mg, multiple ascending dose (MAD) cohort of the Phase 1 clinical trial has been extended to 8 weeks, with a fifth weekly dose administered to the first patient. This extension aims to evaluate longer-term early efficacy and patient exposure to DA-1726, while also exploring the non-titrated maximum tolerated dose. The original trial design and previous results have informed this extension, which is expected to provide more robust data.

DA-1726 is a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity. The extension is designed to explore safety and other primary, secondary, and exploratory endpoints over a longer treatment duration, including body weight, waist circumference, and body mass index (BMI). The Phase 1 trial is a randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726 in obese, otherwise healthy subjects.

The primary endpoint of the Phase 1 trial is to assess the safety and tolerability of DA-1726 by monitoring adverse events (AEs), serious adverse events (SAEs), treatment emergent adverse events (TEAEs), and AEs leading to treatment discontinuation. Secondary endpoints include the PK of DA-1726, assessed via serum concentrations over time and metabolite profiling at the highest doses of DA-1726. Exploratory endpoints include the effect of DA-1726 on metabolic parameters, cardiac parameters, fasting lipid levels, body weight, waist circumference, and BMI, among others.

Previously reported data from the 32 mg dose of DA-1726 demonstrated strong weight loss effects (mean: 4.3%, max: 6.3% by Day 26), early satiety in 83% of patients, and waist reductions of up to 3.9 inches by Day 33. These findings, along with favorable glycemic and cardiovascular safety and a mild, transient GI profile, suggest that DA-1726 may offer a superior tolerability profile compared to existing GLP-1 therapies.

MetaVia believes that DA-1726's 3:1 balanced activation of GLP-1 and glucagon receptors may offer a differentiated safety profile that addresses the well-documented tolerability issues seen with current GLP-1 agonists, where discontinuation rates reach 20–30% within the first month and up to 70% within a year. The company looks forward to reporting top-line data from the extended 48 mg cohort later this year, which may further validate DA-1726's longer-term safety, early efficacy, and differentiated tolerability profile compared to current GLP-1 therapies.

References:
1. [1] https://www.marketscreener.com/news/metavia-extends-48-mg-mad-portion-of-its-phase-1-clinical-trial-of-da-1726-for-the-treatment-of-obesity-to-8-weeks-and-announces-fifth-weekly-dose-in-first-patient-302522928.html