The Phase 1 Part 3 trial will enroll a total of 40 obese, otherwise healthy adult subjects, divided into two cohorts. Each cohort will consist of 20 subjects, randomized in a 4:1 ratio (16 active; 4 placebo). The trial aims to evaluate two different titration regimens: Part 3A will assess a one-step titration regimen with 16 mg for 4 weeks followed by 48 mg for 12 weeks, while Part 3B will evaluate a two-step titration regimen with 16 mg for 4 weeks, 32 mg for 4 weeks, and 64 mg for 8 weeks. The study will focus on safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DA-1726.
Primary endpoints will include monitoring adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs), and AEs leading to treatment discontinuation. Secondary and exploratory endpoints will include PK profiling and evaluation of metabolic, glycemic, lipid, and body composition measures, such as weight, waist circumference, and body mass index (BMI).
Hyung Heon Kim, President and CEO of MetaVia, expressed optimism regarding the IRB approval, stating, "This marks a key milestone in the advancement of DA-1726 and builds on the program's increasingly compelling clinical profile across efficacy, safety, and tolerability. In earlier cohorts, the 48 mg dose produced approximately 9% weight loss, meaningful reductions in waist circumference, improved blood sugar control, and early signals of direct liver benefit, all with a favorable safety profile."
The company plans to initiate initial dosing in April 2026, with data expected in the fourth quarter of 2026. This trial is expected to further de-risk the program and support the advancement of DA-1726 into later-stage development, reinforcing its potential as a differentiated, next-generation GLP-1-based therapy that could offer meaningful advantages over existing options.
