MetaVia Wins IRB Approval for Phase 1 Part 3 Dosing of DA-1726 to 64 mg
MetaVia received IRB approval to initiate Phase 1 Part 3 studies of obesity candidate DA-1726, a GLP-1/glucagon dual agonist, enrolling 40 obese adults in one-step titration to 48 mg and two-step to 64 mg. Earlier cohorts showed ~9% weight loss and improved glycemic control; data expected Q4 2026.
1. IRB Approval and Trial Initiation
The Institutional Review Board at Clinical Pharmacology of Miami has approved MetaVia’s Phase 1 Part 3 clinical trial for DA-1726, enabling the company to advance its lead GLP-1/glucagon dual agonist into higher-dose studies. This milestone follows completion of initial dose-escalation cohorts and clears the way for expanded safety and tolerability evaluation.
2. Part 3 Dosing Regimens and Enrollment
Part 3 will enroll 40 obese, otherwise healthy adults randomized 4:1 (16 active; 4 placebo) in two 16-week cohorts. Cohort A uses a one-step titration of 16 mg for 4 weeks then 48 mg for 12 weeks, while Cohort B tests a two-step regimen of 16 mg for 4 weeks, 32 mg for 4 weeks and 64 mg for 8 weeks, assessing safety, tolerability, PK and PD.
3. Prior Cohort Efficacy and Safety
In earlier Phase 1 cohorts, the 48 mg dose of DA-1726 achieved approximately 9% mean weight loss alongside meaningful waist circumference reductions and improved blood sugar control, with early signals of direct liver benefit. The favorable safety profile and tolerability observed to date support exploration of higher target doses.
4. Timeline and Development Outlook
MetaVia plans to begin Part 3 dosing in April, with top-line data anticipated in the fourth quarter of 2026. Positive results could de-risk the DA-1726 program and pave the way for later-stage development, positioning the candidate as a next-generation therapy with faster dose optimization versus current market leaders.