Theme
Phase 3 pediatric type 2 diabetes trial
Tirzepatide in adolescents with type 2 diabetes
Source
Source: Hannon et al. report the SURPASS-PEDS phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes, published in The Lancet in 2025. The trial is registered with ClinicalTrials.gov as NCT05260021.
Can weekly tirzepatide improve blood sugar and BMI in youth-onset type 2 diabetes? Over 30 weeks, HbA1c fell substantially, BMI improved, and benefits were sustained to 1 year.
Why it matters
Youth-onset type 2 diabetes is difficult to control, with limited approved pharmacologic options for adolescents.
This trial tests whether tirzepatide can address both core clinical targets: glycaemic control and excess BMI.
Study at a glance
Design
Phase 3, double-blind, placebo-controlled
Population
Ages 10 to <18 years with type 2 diabetes
Randomized
99 participants across 3 groups
Treatment arms
Tirzepatide 5 mg, tirzepatide 10 mg, or placebo
Hero finding at week 30
−2.23 pp
HbA1c change with pooled tirzepatide
Placebo increased by +0.05 percentage points; estimated treatment difference −2.28 percentage points.
HbA1c change from baseline
Key efficacy outcomes
−2.23%
HbA1c reduction with pooled tirzepatide
Comparator: +0.05% with placebo at 30 weeks.
−2.28%
Estimated treatment difference vs placebo
HbA1c, pooled tirzepatide vs placebo.
52 wk
Benefits sustained through extension
Durability reported through the 52-week extension.
BMI impact at 30 weeks
10 mg
Largest BMI decrease
−11.2%
5 mg
Clinically meaningful BMI decrease
−7.4%
Placebo
Minimal BMI change
−0.4%
Safety profile
Gastrointestinal events
Most common adverse events; all mild to moderate.
2
Discontinued due to adverse events
Both participants were in the tirzepatide 5 mg group.
0
Deaths reported
Adverse events decreased over time.
Numbers to know
99
Adolescents randomized
10 to <18 yr
Pediatric age range
30 wk
Primary efficacy time point
Takeaway: Tirzepatide appears to be a promising therapeutic option for youth-onset type 2 diabetes, offering meaningful improvements in both HbA1c and BMI, with careful clinical monitoring for gastrointestinal tolerability and longer-term safety.
AbbreviationsQuick
Abbreviations: BMI, body-mass index; CI, confidence interval; DOI, digital object identifier; GLP-1, glucagon-like peptide-1; HbA1c, glycated haemoglobin; NCT, ClinicalTrials.gov identifier; PMID, PubMed identifier; SD, standard deviation; 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. Epub 2025 Sep 17. (DOI: 10.1016/S0140-6736(25)01774-X)
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