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).
- 1Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
- 2Department of Biostatistics, Wakayama Medical University, Wakayama, Japan.
Abstract
Imeglimin, a novel oral antidiabetic agent classified as a glimin, was developed for the treatment of type 2 diabetes (T2D). This single-center, single-arm interventional study evaluated the efficacy and safety of 24-week imeglimin treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and T2D. Patients with MASLD and T2D were treated with imeglimin 1000 mg twice daily for 24 weeks. The primary endpoint was reduction in alanine aminotransferase (ALT) levels from baseline. Secondary endpoints included changes in metabolic parameters (including hemoglobin A1c, homeostatic model assessment of β-cell function, and homeostatic model assessment of insulin resistance), liver-related parameters (including aspartate aminotransferase [AST], gamma-glutamyl transpeptidase, hepatic fat, and fibrosis markers), and body composition. Twenty-five patients were included in the final analysis. As a primary outcome, the median ALT level was significantly reduced, 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 level and hemoglobin A1c value were also significantly reduced. The fibrosis-4 index showed a significant reduction at 12 weeks. By contrast, no significant changes were observed for gamma-glutamyl transpeptidase, homeostatic model assessment of β-cell function, homeostatic model assessment of insulin resistance, hepatic fat content parameters, other fibrosis-related parameters (excluding fibrosis-4 index), and body composition. All adverse events were grade 1, and no patients discontinued treatment due to adverse events. Imeglimin treatment was associated with improvements in serum ALT and AST levels after 24 weeks in patients with MASLD and T2D. These findings provide preliminary evidence of the potential clinical utility of imeglimin in this population and warrant confirmation in larger randomized controlled studies.
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BibTeX
@article{yamada2026efficacy,
title = {{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).}},
author = {Hiroki Yamada and Yoshiyuki Ida and Shiori Kaji and Yoshitaka Nagai and Shuya Maeshima and Ryo Shimizu and Toshio Shimokawa and Masayuki Kitano},
journal = {Medicine},
year = {2026},
month = oct,
doi = {10.1097/md.0000000000051083},
url = {https://europepmc.org/article/MED/42888537},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - 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).
AU - Hiroki Yamada
AU - Yoshiyuki Ida
AU - Shiori Kaji
AU - Yoshitaka Nagai
AU - Shuya Maeshima
AU - Ryo Shimizu
AU - Toshio Shimokawa
AU - Masayuki Kitano
PY - 2026
DA - 2026/10/01
JO - Medicine
DO - 10.1097/md.0000000000051083
UR - https://europepmc.org/article/MED/42888537
AB - Imeglimin, a novel oral antidiabetic agent classified as a glimin, was developed for the treatment of type 2 diabetes (T2D). This single-center, single-arm interventional study evaluated the efficacy and safety of 24-week imeglimin treatment in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and T2D. Patients with MASLD and T2D were treated with imeglimin 1000 mg twice daily for 24 weeks. The primary endpoint was reduction in alanine aminotransferase (ALT) levels from baseline. Secondary endpoints included changes in metabolic parameters (including hemoglobin A1c, homeostatic model assessment of β-cell function, and homeostatic model assessment of insulin resistance), liver-related parameters (including aspartate aminotransferase [AST], gamma-glutamyl transpeptidase, hepatic fat, and fibrosis markers), and body composition. Twenty-five patients were included in the final analysis. As a primary outcome, the median ALT level was significantly reduced, 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 level and hemoglobin A1c value were also significantly reduced. The fibrosis-4 index showed a significant reduction at 12 weeks. By contrast, no significant changes were observed for gamma-glutamyl transpeptidase, homeostatic model assessment of β-cell function, homeostatic model assessment of insulin resistance, hepatic fat content parameters, other fibrosis-related parameters (excluding fibrosis-4 index), and body composition. All adverse events were grade 1, and no patients discontinued treatment due to adverse events. Imeglimin treatment was associated with improvements in serum ALT and AST levels after 24 weeks in patients with MASLD and T2D. These findings provide preliminary evidence of the potential clinical utility of imeglimin in this population and warrant confirmation in larger randomized controlled studies.
SN - 0304-5412
SN - 1536-5964
ER -