Lancet

EASD 2025: Tirzepatide delivers strong glycemic control in youth with T2DM

September 24, 2025

Tirzepatide demonstrated substantial glycemic and weight benefits in children and adolescents with T2DM, a population with few effective treatment options. These findings, presented at the European Association for the Study of Diabetes (EASD) annual meeting, support tirzepatide as a promising new therapeutic candidate pending regulatory review.

Study details: SURPASS-PEDS (NCT05260021) was a randomized, double-blind, placebo-controlled phase 3 trial evaluating once-weekly tirzepatide (5, 10, or 15 mg) vs. placebo in participants aged 10 to <18 years with T2DM. All were on stable background therapy with metformin and/or basal insulin. Primary endpoint was change in HbA1c at 30 weeks.

Results: Of 146 screened participants, 99 were randomized to tirzepatide 5 mg (n=32), tirzepatide 10 mg (n=33), or placebo (n=34). The cohort was 61% female, with a mean age of 14.7 years and mean baseline HbA1c of 8.04%. At 30 weeks, pooled tirzepatide groups achieved a mean HbA1c reduction of 2.23% vs. a 0.05% increase with placebo (estimated treatment difference −2.28%; 95% confidence interval [CI] −2.87 to −1.69; p<0.0001). BMI decreased by 7.4% (5 mg) and 11.2% (10 mg) vs. 0.4% with placebo. Glycemic and BMI benefits persisted through 52 weeks. GI adverse events were most common, generally mild to moderate, and declined over time; discontinuation due to adverse events was infrequent. No deaths occurred, and the safety profile mirrored adult data.

Source:

Hannon TS, et al. (2025, September 17). Lancet. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. https://pubmed.ncbi.nlm.nih.gov/40975112/