Theme

SURPASS-PEDS · Phase 3 pediatric type 2 diabetes

Tirzepatide significantly improved blood sugar control and reduced BMI in youth with type 2 diabetes

Source
Source: Lancet phase 3 trial publication on tirzepatide in children and adolescents with type 2 diabetes, titled “Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS).” The trial is registered as ClinicalTrials.gov NCT05260021.

In adolescents with inadequately controlled type 2 diabetes, tirzepatide produced large HbA1c reductions versus placebo and meaningful BMI decreases at 30 weeks.

Hero finding
−2.23 pp
HbA1c change with tirzepatide at 30 weeks
+0.05 pp
HbA1c change with placebo

Study at a glance

Design
Phase 3, randomized, double-blind, placebo-controlled
Population
Ages 10 to <18 years with type 2 diabetes
Comparator
Tirzepatide 5 mg or 10 mg vs placebo
99 randomized
39 sites · 8 countries
30-week primary readout; 52-week follow-up
Primary glycaemic outcome

HbA1c change at week 30

Estimated treatment difference
−2.28 pp
vs placebo; p<0.0001

BMI reductions at week 30

Randomized cohort
99
participants aged 10 to <18 years
Trial footprint
39
sites
8
countries
Study arms
5 mg · 10 mg
tirzepatide doses compared with placebo

Key findings

HbA1c treatment difference
−2.28 pp
Estimated difference versus placebo at week 30
Statistical significance
p<0.0001
For HbA1c treatment difference at week 30
BMI · tirzepatide 5 mg
−7.4%
Change at week 30
BMI · tirzepatide 10 mg
−11.2%
Change at week 30
BMI · placebo
−0.4%
Change at week 30
Durability
52 weeks
Benefits were sustained through follow-up

Safety signal

GI adverse events

Gastrointestinal side effects were the most common safety issue reported with tirzepatide.

Interpretation guardrails

Relatively small pediatric trial: 99 randomized participants.
Industry-funded study; independent confirmation and real-world evidence will be important.
Long-term monitoring remains important, particularly for tolerability and durability in adolescents.

Takeaway

Tirzepatide shows strong promise as an effective option for adolescents with inadequately controlled type 2 diabetes, improving both glycaemic control and BMI.

AbbreviationsQuick
Abbreviations: BMI=body-mass index; CI=confidence interval; GLP-1=glucagon-like peptide-1; HbA1c=glycated haemoglobin; SD=standard deviation.
Bibliography1
  1. Hannon TS, Chao LC, Barrientos-Pérez M, Pamidipati KC, Landó LF, Lee CJ, Patel H, Bergman BK. 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 Oct 4;406(10511):1484-1496. (DOI: 10.1016/S0140-6736(25)01774-X)