Lancet

EASD 2025: Low-dose antithymocyte globulin preserves beta-cell function in new-onset T1DM

September 23, 2025

Low-dose antithymocyte globulin (ATG) offers a promising immunomodulatory strategy to preserve beta cell function in youth with recent-onset T1DM, potentially reducing long-term insulin dependence. These findings were presented at the European Association for the Study of Diabetes (EASD) annual meeting.

Study details: MELD-ATG (NCT04509791) was a phase 2, double-blind, randomized, placebo-controlled, adaptive dose-ranging study conducted across 14 centers in eight European countries. It enrolled 117 participants aged 5 to 25 years within 3 to 9 weeks of stage 3 T1DM diagnosis. Participants were stratified by age and randomized to receive placebo or one of four ATG doses (0.1, 0.5, 1.5, or 2.5 mg/kg) via IV infusion over two days. Primary outcome was the area under the curve (AUC) of the stimulated C-peptide concentration during a 2-h mixed-meal tolerance test at 12 months

Results: At 12 months, the 2.5 mg/kg ATG group showed a significant improvement in beta cell function vs. placebo (mean difference 0.124 nmol/L/min; 95% confidence interval [CI] 0.043–0.205; p=0.0028). The 0.5 mg/kg dose also demonstrated efficacy (mean difference 0.102 nmol/L/min; 95% CI 0.021–0.183; p=0.014) with fewer adverse events. Cytokine release syndrome and serum sickness occurred in 33% and 82% of the 2.5 mg/kg group, respectively, compared with 24% and 32% in the 0.5 mg/kg group.

Source:

Mathieu C, et al; INNODIA. (2025, September 18). Lancet. Minimum effective low dose of antithymocyte globulin in people aged 5-25 years with recent-onset stage 3 type 1 diabetes (MELD-ATG): a phase 2, multicentre, double-blind, randomised, placebo-controlled, adaptive dose-ranging trial. https://pubmed.ncbi.nlm.nih.gov/40976248/