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
Authors' conclusion
In young people with recent-onset, clinical type 1 diabetes, 2.5 mg/kg and 0.5 mg/kg ATG reduced loss of β-cell function, showing the potential of an affordable, repurposed agent, ATG, in a low and safe dose, as a disease-modifying agent in this population.
Study context
- Population
- People aged 5–25 years with clinical, stage 3 T1D diagnosed 3–9 weeks before treatment, random C-peptide ≥0.2 nmol/L and ≥1 diabetes-related autoantibody; 14 centres in eight countriesrandomly assigned
- Participants
- 117 people
- Comparison
- Antithymocyte globulin (ATG) vs placebo
- Placebon = 31reference
- 0.1 mg/kg ATGn = 6
- 0.5 mg/kg ATGn = 35
- 1.5 mg/kg ATGn = 12
- 2.5 mg/kg ATGn = 33
- Primary endpoint
- Stimulated C-peptide AUC during 2-h mixed-meal tolerance test, as ln(AUC C-peptide + 1)
- Follow-up
- 12 months
Methodological detailsphase 2, double-blind, placebo-controlled, multi-arm, adaptive dose-ranging, parallel-cohort, multicentre
- Phase 2
- Double-blind
- Placebo-controlled
- Multi-arm
- Adaptive dose-ranging
- Parallel-cohort
- Multicentre
Primary result
As reported in the abstract
Ln(AUC C-peptide + 1)
Each group vs placeboEstimate (95% CI)P value
2.5 mg/kg ATG
mean difference 0.124 nmol/L per min(0.043–0.205)
P = 0.00280.5 mg/kg ATG
mean baseline-adjusted difference 0.102 nmol/L per min(0.021–0.183)
P = 0.014Further findings
- No deaths related to adverse events
Safety
| Outcome | 2.5 mg/kg ATG | 0.5 mg/kg ATG | Placeboevents |
|---|---|---|---|
| Cytokine release syndrome | 33% | 24% | 0 |
| Serum sickness | 82% | 32% | 0 |
Original publication
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. Lancet. Published 18 September 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →