Clinical-stage biotechnology company MetaVia Inc (Nasdaq:MTVA) announced on Thursday that all enrolled active patients in Part 3 of its Phase 1 clinical trial evaluating DA-1726 for the treatment of obesity have successfully completed dose titration and are now receiving their highest target doses in both study cohorts.

DA-1726 is a novel oxyntomodulin (OXM) analogue 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. In Part 3A, patients titrated from 16 mg to 48 mg, while in Part 3B, patients titrated from 16 mg to 32 mg and subsequently to 64 mg.

The Phase 1 Part 3 trial has a planned enrolment of approximately 40 obese, otherwise healthy adult subjects, across two parts, with approximately 20 subjects per part, randomised 4:1 (16 active; 4 placebo). Part 3A is designed to evaluate 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 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, glycaemic, lipid, and body composition measures, including weight, waist circumference, and body mass index (BMI), and other cardiometabolic measures.

According to MetaVia, in preclinical mice models DA-1726 resulted in improved weight loss compared to semaglutide (Wegovy), a leading GLP-1 receptor agonist.