MetaVia, a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, has announced that the first patient has been dosed in part 3 of its phase 1 clinical trial evaluating DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors.
Part 3 of the phase 1 programme consists of two 16-week titration cohorts designed to evaluate one-step and two-step dose-escalation strategies to safely achieve higher target doses and further optimise tolerability.
‘Dosing the first patient in these higher-dose cohorts is an exciting milestone that moves us closer to unlocking the full potential of DA-1726,’ stated Hyung Heon Kim, President and Chief Executive Officer of MetaVia.
‘We have already seen compelling results, including approximately 9% weight loss at the 48 mg dose, along with meaningful reductions in waist circumference, improved glycemic control, and early signals of direct liver benefit, all with a favorable tolerability profile. We believe these results highlight the potential of our dual GLP-1/glucagon approach.
‘Importantly, part 3 is designed to reach higher therapeutic doses with improved tolerability, which could represent a meaningful advantage compared to currently marketed therapies that require longer, more gradual titration.
‘With data expected in the fourth quarter of 2026, we are focused on further demonstrating DA-1726’s potential to deliver differentiated efficacy and a more streamlined path to optimal dosing.’
The phase 1 part 3 trial is expected to enroll a total of 40 obese, otherwise healthy adult subjects, across two parts, with 20 subjects per part, randomised 4:1 (16 active; four placebo).
Part 3A is designed to evaluate a one-step titration regimen with 16 mg for four weeks followed by 48 mg for 12 weeks, while part 3B will evaluate a two-step titration regimen with 16 mg for four weeks, 32 mg for four weeks, and 64 mg for eight weeks.
The study will assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726. Primary endpoints include monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to treatment discontinuation.
Secondary and exploratory endpoints include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, including weight, waist circumference, and body mass index (BMI), and other cardiometabolic measures.
For more information on this clinical trial, please visit: www.clinicaltrials.gov NCT06252220.
