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SURPASS-PEDS phase 3 clinical infographic
Tirzepatide for adolescents with type 2 diabetes: glycaemic control and BMI over 30 weeks
Source
Source: Lancet phase 3 trial publication on tirzepatide in children and adolescents with type 2 diabetes, identified as SURPASS-PEDS. The study compared tirzepatide with placebo over a 30-week double-blind period followed by an open-label extension.
Tirzepatide markedly improved blood sugar control and reduced BMI in adolescents with type 2 diabetes over 30 weeks, with benefits sustained to 1 year.
Why this matters
Youth-onset type 2 diabetes is difficult to treat, and current options often deliver weaker glycaemic control than in adults. A treatment that improves both HbA1c and BMI could meaningfully change specialist paediatric diabetes care.
Trial snapshot: SURPASS-PEDS
Design
Randomised, double-blind, placebo-controlled phase 3 trial
Population
Participants aged 10 to <18 years with type 2 diabetes
Background therapy
Inadequately controlled on metformin and/or basal insulin
Arms
Tirzepatide 5 mg, tirzepatide 10 mg, or placebo
Primary endpoint
Week 30; benefits reported as sustained to 1 year
Hero fact
HbA1c at week 30
−2.23 pp
HbA1c change with tirzepatide
−2.28%
Estimated treatment difference
+0.05 pp
HbA1c change with placebo
Participants
99
participants randomised to tirzepatide 5 mg, tirzepatide 10 mg, or placebo
Mean age 14.7 y
Baseline HbA1c 8.04%
Glycaemic efficacy
−2.28%
estimated treatment difference in HbA1c at week 30
p<0.0001
BMI response
−11.2%
BMI change with tirzepatide 10 mg at week 30
5 mg: −7.4% | Placebo: −0.4%
Efficacy results: BMI reduction by treatment arm
Dose-level signal
−7.4%
BMI decrease with tirzepatide 5 mg
−11.2%
BMI decrease with tirzepatide 10 mg
−0.4%
BMI decrease with placebo
Numbers to know
−2.23 pp
HbA1c change with tirzepatide at week 30
+0.05 pp
HbA1c change with placebo at week 30
−2.28%
estimated treatment difference; p<0.0001
8.04%
mean baseline HbA1c among randomised participants
Safety profile
Common adverse events
Mostly gastrointestinal events
Pattern over time
Generally mild to moderate and decreasing over time
Mortality
No deaths reported
Tirzepatide appears to be a strong emerging treatment option for youth-onset type 2 diabetes, improving both glycaemic control and BMI; treatment decisions should be individualised with specialist paediatric diabetes care.
AbbreviationsQuick
Abbreviations: SURPASS-PEDS; HbA1c = glycated haemoglobin; GLP-1; BMI; CI; DOI; PMID.
Bibliography1
- 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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