Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial
An erratum to this article was published (Lancet, 4 Oct 2025 ↗)
Primary result · Change in HbA1cResult — go to the resultEstimated treatment difference −2.28 % 95% CI −2.87 to −1.69Authors' conclusion
Tirzepatide demonstrated significant improvements in glycaemic control and BMI compared with placebo. These effects were sustained over 1 year.
Study context
- Population
- Participants aged 10 to <18 years with youth-onset T2D inadequately controlled with metformin and/or basal insulin; mean age 14.7 years, mean baseline HbA1c 8.04%randomly assigned 1:1:1
- Participants
- 99 participants
- Comparison
- Tirzepatide 5 mg or 10 mg vs placebo
- Tirzepatide 5 mgn = 32
- Tirzepatide 10 mgn = 33
- Placebon = 34reference
- Primary endpoint
- Change in HbA1c from baseline
- Follow-up
- Week 30
Methodological detailsphase 3, double-blind, placebo-controlled, multicentre (39 sites), multinational (eight countries), 22-week open-label extension, Randomisation stratified by age group (≤14 or >14 years) and antihyperglycaemic medication, Efficacy and safety analysed in all participants receiving ≥1 dose
- Phase 3
- Double-blind
- Placebo-controlled
- Multicentre (39 sites)
- Multinational (eight countries)
- 22-week open-label extension
- Randomisation stratified by age group (≤14 or >14 years) and antihyperglycaemic medication
- Efficacy and safety analysed in all participants receiving ≥1 dose
Primary result
Change in HbA1c
Estimated treatment difference
−2.28 %
95% CI −2.87 to −1.69
P < 0.0001
Change by group
Tirzepatide (pooled)
2.23%
mean reduction
Placebo
0.05%
increase
Tirzepatide (pooled)vs Placebo
estimated treatment difference −2.28 % (95% CI −2.87 to −1.69); P < 0.0001
As reported in the abstract
Further findings
BMI reduction · 30 weeks
Glycaemic efficacy · up to 52 weeks
- Glycaemic efficacy was sustained up to 52 weeks with tirzepatide
BMI reduction · 30 weeks
- Significant reductions in BMI with tirzepatide
Safety
Adverse events
- Discontinued study drug due to an AE, tirzepatide 5 mg
- 2 (6%)
- Deaths
- 0
- Most common AEs with tirzepatide were gastrointestinal, all mild to moderate, decreasing over time
- Safety profile consistent with that reported in adults
Original publication
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. Published 17 September 2025. doi:10.
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