- DA-1241 Demonstrated Direct Hepatic Action in Addition to Its Glucose Lowering Effect
- Patients Treated with DA-1241 100mg Achieved Statistically Significant Reduction in ALT Levels at Weeks 4 and 8, and a Near Statistically Significant Reduction at Week 16
- DA-1241 100mg Demonstrated Statistically Significant Improvements in CAP Score at Week 16
- DA-1241 100mg Showed Statistically Significant Reductions in HbA1C at Week 16
- DA-1241 was Very Well Tolerated
- Awaiting Data on Other Exploratory Endpoints Including MRI-PDFF
- Additional Findings to be Submitted for Upcoming Scientific Conferences
CAMBRIDGE, Mass., Dec. 18, 2024 /PRNewswire/ -- MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced positive top-line 16-week results from the two-part Phase 2a clinical trial in patients with presumed metabolic dysfunction-associated steatohepatitis (MASH). Part 1 of this Phase 2a trial is exploring DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist compared to placebo, while Part 2 is investigating the efficacy of DA-1241 in combination with sitagliptin, a DPP-4 inhibitor. In this trial, DA-1241 (100mg) demonstrated a statistically significant reduction in alanine transaminase (ALT) levels at weeks 4 and 8, with a near statistically significant reduction at week 16. Statistically significant results were also achieved in multiple secondary endpoints including reductions in controlled attenuation parameter (CAP) and hemoglobin A1C (HbA1c) (see tables below). DA-1241 demonstrated similar trends in other liver enzymes including aminotransferase (AST) and gamma-glutamyl transferase (GGT).
Primary Efficacy Endpoint
LS Mean ALT Changes from Baseline (U/L)
Placebo (N=23) | DA-1241 100mg + Sitagliptin 100mg (N=34) | P value vs.PBO | DA-1241 50mg (N=12) | P value vs. PBO | DA-1241 100mg (N=22) | P value vs.PBO | |
Baseline Mean | 68.4 | 63.2 | 65.8 | 57.2 | |||
Week 4 LS Mean (95% CI) | -1.51 (-8.23, 5.21) | -8.38 (-13.89, -2.87)* | 0.1195 | -9.63 (-18.90, -0.35)* | 0.1622 | -13.44 (-20.32, -6.57)* | 0.0159† |
Week 8 LS Mean (95% CI) | 0.13 (-7.83, 8.09) | -10.27 (-16.80, -3.73)* | 0.0479† | -11.05 (-22.04, -0.05)* | 0.1050 | -12.25 (-20.40, -4.10)* | 0.0342† |
Week 16 LS Mean (95% CI) | -4.70 (-14.05, 4.65) | -8.24 (-15.91, -0.57)* | 0.5624 | -16.81 (-29.72, -3.89)* | 0.1345 | -18.09 (-27.67, -8.52)* | 0.0506 |
* Confidence interval excludes 0, suggesting a statistically meaningful difference.† p < 0.05 vs. placebo |
Notable Secondary Endpoints
Proportion of Subjects with Normalized ALT