SURPASS-PEDS: Tirzepatide improved HbA1c, BMI in youth

Theme

Phase 3 adolescent type 2 diabetes trial

Tirzepatide markedly improved blood sugar control and reduced BMI in adolescents with type 2 diabetes over 30 weeks

Source
Source: Hannon et al., The Lancet (2025), reporting SURPASS-PEDS, a randomised, double-blind, placebo-controlled phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes. The trial is registered with ClinicalTrials.gov (NCT05260021).

In youth with type 2 diabetes inadequately controlled on metformin and/or basal insulin, once-weekly tirzepatide delivered large HbA1c reductions versus placebo, with dose-related BMI decreases.

Hero fact
−2.23 pp
HbA1c change with pooled tirzepatide at week 30
+0.05 pp with placebo
Design
Randomized, double-blind, placebo-controlled
Population
Age 10 to <18 years; T2D inadequately controlled
Arms
Tirzepatide 5 mg, 10 mg, or placebo
Duration
30 weeks
Sites
39 sites across 8 countries

Primary glycaemic signal

HbA1c change from baseline to week 30; lower values indicate greater improvement.

ETD −2.28 pp
pooled tirzepatide vs placebo

Why it matters

Youth-onset type 2 diabetes has limited treatment options and is often harder to control than adult-onset disease. A therapy that improves both glycaemic control and BMI addresses two central clinical challenges in this population.

HbA1c
−2.23 pp
with pooled tirzepatide versus +0.05 pp with placebo at 30 weeks
Estimated treatment difference: −2.28 pp
BMI
−7.4%
tirzepatide 5 mg
−11.2%
tirzepatide 10 mg
−0.4%
with placebo at 30 weeks
Safety
0
deaths reported
Most common adverse events were gastrointestinal, generally mild to moderate, and decreased over time.

Endpoint results at week 30

Endpoint Tirzepatide 5 mg Tirzepatide 10 mg Pooled tirzepatide Placebo Contrast
HbA1c change Dose-specific value not stated in supplied brief Dose-specific value not stated in supplied brief −2.23 pp +0.05 pp ETD −2.28 pp
BMI change −7.4% −11.2% Pooled value not stated in supplied brief −0.4% Dose-related BMI reduction versus placebo

BMI reduction: dose pattern

Percent change in BMI at week 30 showed larger reductions with the 10 mg dose than the 5 mg dose, while placebo changed minimally.

Tirzepatide 10 mg−11.2%
Tirzepatide 5 mg−7.4%
Placebo−0.4%
Clinical context

BMI reduction is clinically relevant in adolescent type 2 diabetes because excess adiposity contributes to insulin resistance and long-term cardiometabolic risk.

30
weeks of treatment
39
trial sites
8
countries
−2.28 pp
HbA1c treatment difference
−11.2%
BMI change with 10 mg
0
deaths reported

Safety and practical context

Adverse events

The most common adverse events were gastrointestinal and were generally mild to moderate.

Tolerability pattern

Gastrointestinal adverse events decreased over time, consistent with the need for early counselling and monitoring.

Discontinuations

Discontinuation rates were not provided in the supplied summary; clinicians should review the full trial report and prescribing information.

Funding disclosure

The study was funded by Eli Lilly and Company.

Takeaway

Tirzepatide appears to offer a meaningful new treatment option for adolescents with type 2 diabetes who remain inadequately controlled on metformin and/or basal insulin, with substantial improvements in glycaemic control and BMI. Interpret the strong efficacy signal alongside safety monitoring, trial-size context, and industry funding disclosure.

AbbreviationsQuick
Abbreviations: BMI = body mass index; CI = confidence interval; GLP-1 = glucagon-like peptide-1; HbA1c = glycated haemoglobin; SD = standard deviation; SURPASS-PEDS = trial name.
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)
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