Trial population
99
randomized children/adolescents
39 sites
across 8 countries
14.7 y
mean age
8.04%
mean baseline HbA1c
Theme
Tirzepatide
SURPASS-PEDS phase 3
Youth type 2 diabetes
Tirzepatide significantly improved blood sugar control and lowered BMI in youth with type 2 diabetes over 30 weeks.
Source
Source: Lancet 2025 publication reporting the SURPASS-PEDS randomized, double-blind, placebo-controlled phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes.
A pediatric “new treatment option signal” from a double-blind, placebo-controlled trial in adolescents with inadequate control on metformin and/or basal insulin.
Why it matters
Youth-onset type 2 diabetes is hard to treat and has fewer effective medication options than adult disease, making durable glycemic control and weight-related benefits clinically important.
Study at a glance
Design
Phase 3, double-blind, placebo-controlled
Population
Age 10 to <18 years; inadequate control on metformin and/or basal insulin
Comparator
Tirzepatide 5 mg or 10 mg vs placebo
Primary duration
30 weeks
Trial footprint
39 sites in 8 countries
Continued-treatment follow-up
Effects reported as sustained through 52 weeks
Hero finding at week 30
−2.28%
Estimated treatment difference in HbA1c vs placebo
−2.23 pp
Tirzepatide HbA1c change
+0.05 pp
Placebo HbA1c change
HbA1c change: active treatment separated sharply from placebo
Glycemic control
Superior to placebo
HbA1c reduction at 30 weeks
−2.23 pp
tirzepatide
+0.05 pp
placebo
Effects were reported as sustained through 52 weeks during continued treatment.
BMI reduction at 30 weeks
11.2%
BMI decrease with tirzepatide 10 mg
7.4%
BMI decrease with tirzepatide 5 mg
0.4%
BMI decrease with placebo
Safety profile
0
deaths reported
GI AEs
most common
Gastrointestinal adverse events were generally mild to moderate and decreased over time; the overall pattern was consistent with the adult safety experience.
Interpretation caveats
Modest sample size: randomized population was 99 participants.
Industry funding: interpretation should account for sponsor involvement.
Longer-term pediatric data needed: durability, growth/puberty context, and safety beyond trial follow-up remain important.
Numbers to know
−2.28%
HbA1c estimated treatment difference
99
randomized participants
14.7
years mean age
8.04%
mean baseline HbA1c
0
deaths reported
52 wk
reported sustained effect during treatment
Practical meaning
Tirzepatide showed strong short-term glycemic and BMI benefits in adolescents with type 2 diabetes, supporting a promising future pediatric treatment option signal — not yet a final practice-changing verdict.
AbbreviationsQuick
Abbreviations: BMI, body mass index; CI, confidence interval; GLP-1, glucagon-like peptide-1; HbA1c, glycated haemoglobin; SURPASS-PEDS, trial name.
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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