The SURPASS-PEDS trial has found that tirzepatide significantly improved glycaemic control and reduced body mass index (BMI) in children and adolescents with type 2 diabetes (T2D) compared with placebo.¹ Youth-onset T2D presents unique challenges, as current treatments often show lower efficacy than in adults, and the disease course can be more aggressive.²

Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist administered as a once-weekly subcutaneous injection.

The phase 3, randomised, double-blind, placebo-controlled SURPASS-PEDS trial was conducted at 39 sites across eight countries. The study enrolled 99 participants aged 10 to <18 years with T2D inadequately controlled with metformin and/or basal insulin. Participants were randomly assigned (1:1:1) to receive tirzepatide 5 mg, tirzepatide 10 mg, or placebo for a 30-week double-blind period, followed by a 22-week open-label extension where all participants received tirzepatide. The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 30.

At 30 weeks, tirzepatide demonstrated superiority over placebo in reducing HbA1c. The mean HbA1c reduction in the pooled tirzepatide group was 2.23%, compared with an increase of 0.05% in the placebo group, resulting in an estimated treatment difference of -2.28% (95% CI -2.87 to -1.69; p<0.0001). This glycaemic efficacy was sustained for up to 52 weeks. Furthermore, tirzepatide led to significant reductions in BMI at 30 weeks, with decreases of 7.4% and 11.2% in the 5 mg and 10 mg groups, respectively, versus a 0.4% reduction in the placebo group. The safety profile was consistent with that observed in adults; the most common adverse events were gastrointestinal in nature, mild to moderate in severity, and decreased over time. Two patients (6%) in the 5 mg group discontinued the study drug due to an adverse event. No deaths were reported.

The investigators concluded that, ‘Tirzepatide demonstrated significant improvements in glycaemic control and BMI compared with placebo. These effects were sustained over 1 year.’¹ These findings suggest that tirzepatide could be a valuable new therapeutic option for managing T2D in this younger population, which is at high risk for early complications.

This study was funded by Eli Lilly and Company.

References

1. Hannon TS, Chao LC, Barrientos-Pérez M, et al. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025. https://doi.org/10.1016/S0140-6736(25)01774-X

2. Bjornstad P, Drews KL, Caprio S, et al. Long-term complications in youth-onset type 2 diabetes. N Engl J Med. 2021;385:416-426. https://doi.org/10.1056/NEJMoa2100165

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