Cambridge, MA — MetaVia Inc. said all active patients in Part 3 of its Phase 1 clinical trial evaluating DA-1726 for obesity have completed dose titration and are now receiving the highest target doses in both study cohorts.
DA-1726 is a novel oxyntomodulin analog that targets both GLP-1 and glucagon receptors. The company is developing the once-weekly subcutaneous treatment for obesity and metabolic dysfunction-associated steatohepatitis, or MASH.
Part 3 of the Phase 1 program includes two 16-week titration cohorts designed to evaluate one-step and two-step dose-escalation strategies to reach higher target doses while further assessing tolerability. In Part 3A, patients titrated from 16 mg to 48 mg. In Part 3B, patients titrated from 16 mg to 32 mg and then to 64 mg.
“The successful completion of dose titration across both Part 3 cohorts represents an important milestone for the DA-1726 development program,” said Hyung Heon Kim, President and Chief Executive Officer of MetaVia. “Reaching our highest planned dose levels in all active patients reinforces the favorable tolerability profile of DA-1726. We believe our efficient titration strategy could represent a meaningful competitive advantage over currently marketed obesity therapies.”
Kim said previously reported Phase 1 multiple ascending dose data showed 9.1 percent mean weight loss at the 48 mg dose after eight weeks of treatment, along with reductions in waist circumference, improved glycemic measures and early signs of liver benefit.
“The robust data from our previously reported Phase 1 MAD study, including 9.1% mean weight loss achieved at the 48 mg dose in just 8 weeks of treatment, meaningful reductions in waist circumference, improved glycemic measures, and early signs of direct liver benefit, continue to demonstrate the differentiated potential of our dual GLP-1/glucagon mechanism. With all patients now on their target doses, we remain focused on completing treatment and reporting topline data in the fourth quarter of 2026,” Kim said.
The Phase 1 Part 3 trial is expected to enroll about 40 obese, otherwise healthy adults across two parts, with about 20 subjects per part randomized 4:1 between active treatment and placebo.
Part 3A is evaluating a one-step titration regimen of 16 mg for four weeks followed by 48 mg for 12 weeks. Part 3B is evaluating a two-step regimen of 16 mg for four weeks, 32 mg for four weeks and 64 mg for eight weeks.
The study is assessing safety, tolerability, pharmacokinetics and pharmacodynamics. Primary endpoints include adverse events, serious adverse events, treatment-emergent adverse events and adverse events leading to treatment discontinuation. Secondary and exploratory endpoints include metabolic, glycemic, lipid and body composition measures, including weight, waist circumference and body mass index.
MetaVia said topline data remain on track for the fourth quarter of 2026.
