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Tirzepatide in youth-onset type 2 diabetes

Tirzepatide markedly improved blood sugar and BMI in youth with type 2 diabetes over 30 weeks

Source
Source: Hannon et al., a Lancet 2025 phase 3 randomized, double-blind, placebo-controlled trial of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS). The study compared tirzepatide with placebo for glycaemic control and BMI outcomes over 30 weeks with extension data to 52 weeks.

A phase 3 trial tested whether tirzepatide could improve glycaemic control in children and adolescents with inadequately controlled type 2 diabetes.

Hero fact
−2.23 pp
HbA1c change with tirzepatide at week 30
+0.05 pp
HbA1c change with placebo

Why it matters

Youth-onset type 2 diabetes is difficult to treat, with fewer approved options and often weaker glycaemic response than in adults. This trial evaluates a promising incretin-based option for adolescents whose diabetes remains inadequately controlled on metformin and/or basal insulin.

Trial at a glance

Design
Randomised, double-blind, placebo-controlled phase 3 trial
Population
Children and adolescents aged 10 to <18 years with inadequately controlled type 2 diabetes
Comparator
Tirzepatide 5 mg or 10 mg versus placebo
Randomised
99
participants across 3 groups
Mean age
14.7
years
Baseline HbA1c
8.04%
mean at randomisation

Central efficacy finding: HbA1c moved in opposite directions

At week 30, tirzepatide produced a large HbA1c reduction while placebo showed a slight increase.

−2.23
percentage points
+0.05
percentage points

BMI change by dose

Safety shown alongside benefit

GI AEs
Most common adverse events; generally mild to moderate
Discontinuations
Interpret tolerability and discontinuation data in context of small sample size
0
deaths reported

Safety interpretation should account for the 30-week duration, 99-participant trial size, and industry funding.

Key findings at week 30

Glycaemic efficacy
−2.28 pp
Estimated treatment difference in HbA1c versus placebo
p<0.0001
BMI response
−7.4%
tirzepatide 5 mg
−11.2%
tirzepatide 10 mg
−0.4%
placebo
Trial context
99
randomised
30
weeks
Mean age 14.7 years; mean baseline HbA1c 8.04%.

Numbers to know

−2.23
pp HbA1c change with tirzepatide
+0.05
pp HbA1c change with placebo
−2.28 pp
estimated treatment difference
p<0.0001
statistical superiority reported
−11.2%
BMI change with tirzepatide 10 mg
0
deaths reported

Takeaway

Tirzepatide is a promising therapeutic option for adolescents with type 2 diabetes inadequately controlled on metformin and/or basal insulin, but longer-term real-world safety, durability, access, and paediatric-use considerations remain important.

AbbreviationsQuick
Abbreviations: BMI, body-mass index; CI, confidence interval; GLP-1, glucagon-like peptide-1; HbA1c, glycated haemoglobin; SURPASS-PEDS, tirzepatide pediatric type 2 diabetes trial.
Bibliography2
  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)
  2. Erratum. Lancet. 2025 Oct 4;406(10511):1472. (DOI: 10.1016/S0140-6736(25)01961-0)