Efficacy and safety of imeglimin hydrochloride for metabolic dysfunction-associated steatotic liver disease with type 2 diabetes: Single-center, single-arm phase 2 (IMELD study).

In 30 seconds

This single-center, single-arm phase 2 interventional study assessed 24 weeks of imeglimin in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and type 2 diabetes. Among 25 patients in the final analysis, median alanine aminotransferase (ALT) fell from 56.00 (47.00-75.00) U/L at baseline to 34.00 (29.00-51.00) U/L at 24 weeks (P < .001). Aspartate aminotransferase and hemoglobin A1c also decreased significantly, while hepatic fat measures and most other assessed liver, metabolic, and body-composition parameters did not change significantly. Adverse events were grade 1, with no treatment discontinuations due to adverse events.

Key findings

• Median ALT decreased from 56.00 (47.00-75.00) U/L at baseline to 34.00 (29.00-51.00) U/L at 24 weeks (P < .001).
• AST and hemoglobin A1c decreased significantly; the fibrosis-4 index was significantly lower at 12 weeks.
• Hepatic fat parameters, most fibrosis-related measures, insulin-resistance and β-cell-function measures, and body composition showed no significant changes.
• All adverse events were grade 1, and no patients stopped treatment because of adverse events.

Why it matters

MASLD commonly coexists with type 2 diabetes, making potential effects of glucose-lowering treatment on liver measures clinically relevant. This study found improvements in serum aminotransferases during imeglimin treatment, but did not show significant changes in hepatic fat or most other liver-related measures. The findings therefore offer an early signal rather than evidence of established liver benefit.

What to keep in mind

The study was single-center and single-arm, with 25 patients in the final analysis and 24 weeks of follow-up; without a comparator, treatment effects cannot be separated from other influences.