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Youth type 2 diabetes | Phase 3 clinical trial

Tirzepatide sharply improved blood sugar and BMI in adolescents with type 2 diabetes

Source
Source: Hannon et al.'s 2025 Lancet publication reporting the SURPASS-PEDS phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes.

In 99 participants aged 10 to <18 years with inadequately controlled type 2 diabetes, tirzepatide produced a large HbA1c reduction at 30 weeks versus placebo, with concurrent BMI decreases.

Phase 3 randomised, double-blind, placebo-controlled
99 participants, age 10 to <18 years
39 sites in 8 countries
Tirzepatide 5 mg or 10 mg vs placebo
30-week primary treatment period

Youth-onset type 2 diabetes is harder to control

Available therapies often deliver weaker glycaemic control in adolescents than in adults. A treatment that improves both HbA1c and BMI addresses two clinically important drivers of long-term cardiometabolic risk.

−2.23 pp HbA1c change with pooled tirzepatide at week 30
+0.05 pp HbA1c change with placebo at week 30
ETD −2.28 pp Estimated treatment difference vs placebo

HbA1c moved decisively in opposite directions

Mean change from baseline to week 30. Negative values indicate improvement.

−2.28 pp Treatment separation

Dose-related BMI reductions at week 30

Percent change in BMI from baseline. Negative values indicate lower BMI.

99 Adolescents randomised
10–<18 Years of age
−11.2% BMI change with tirzepatide 10 mg
−0.4% BMI change with placebo

Glycaemic control

−2.23% Pooled tirzepatide HbA1c change at 30 weeks
Placebo: +0.05%; estimated treatment difference: −2.28 percentage points.

BMI

−7.4% / −11.2% BMI change with tirzepatide 5 mg / 10 mg
Placebo BMI change at 30 weeks: −0.4%.

Safety

0 Deaths reported
Gastrointestinal adverse events were most common, mostly mild to moderate, and decreased over time.

Adverse-event pattern matched adult experience

GI events most common Mostly mild to moderate Decreased over time No deaths
2 Discontinuations in the tirzepatide 5 mg group
0 Deaths reported

Strong efficacy signal, but monitor paediatric evidence over time

Balance the result: the trial was relatively small, industry-funded, and longer-term paediatric safety plus real-world durability remain important to monitor, including after the 52-week extension period.

Tirzepatide appears to be a strong emerging treatment option for adolescents with inadequately controlled type 2 diabetes, improving both HbA1c 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. Epub 2025 Sep 17. (DOI: 10.1016/S0140-6736(25)01774-X)