Key Findings
In the interim analysis of Phase 1 Part 3B, DA-1726 achieved a 68% reduction in liver fat compared to the placebo group after 16 weeks of treatment. The DA-1726 group showed a 13.5% weight reduction compared to placebo, with an average weight loss of 12.19 kg (an 11.9% reduction from baseline). Using MRI-PDFF, 10 out of 12 participants (83%) in the treatment group reduced liver fat content by 30% or more from baseline. Notably, all five participants who had fatty liver at the start of the trial saw their MRI-PDFF levels drop below 5%, with average liver fat content decreasing from 8.3% to 3.0%.
Technical Details
DA-1726 is an oxyntomodulin analogue that acts simultaneously on GLP-1 and glucagon receptors. This dual action suppresses appetite, promotes insulin secretion, and increases basal metabolic rate in peripheral tissues to induce weight loss and blood glucose control. The Phase 1 Part 3B study was a randomized, placebo-controlled trial involving 15 participants in the DA-1726 group and 4 in the placebo group. Participants received weekly subcutaneous injections for 16 weeks, with doses escalating from 16mg to 32mg and finally to a target dose of 64mg.
- Glycemic Control: Average HbA1c in non-diabetic participants decreased from 5.79% to 5.33%, a 0.24 percentage point reduction compared to placebo.
- Body Composition: Compared to placebo, visceral fat decreased by 22%, while abdominal subcutaneous fat and total adipose tissue decreased by 19%. Lean body mass and thigh muscle volume decreased by 8% and 9%, respectively.
- Safety: Nine of 15 participants in the treatment group experienced gastrointestinal adverse events, mostly mild to moderate. One serious adverse event involving severe vomiting was reported, though the participant recovered.
Significance and Outlook
Based on these results, MetaVia plans to expand the development of DA-1726 to include metabolic dysfunction-associated steatotic liver disease (MetALD) and alcohol-related liver disease (ALD). MetaVia estimates there are approximately 10.7 million adult MetALD patients in the United States. The company intends to release full data for Phase 1 Part 3A and 3B in the first quarter of 2027, followed by a 48-week Phase 2 trial for up to 150 MetALD and ALD patients in the second half of 2027, utilizing a design that omits liver biopsies to reduce patient burden and costs.
Source: https://www.yakup.com/news/?mode=view&cat=12&cat2=121&cat3=0&nid=334867
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