Theme


Phase 3 pediatric type 2 diabetes trial

Tirzepatide in adolescents with type 2 diabetes: meaningful HbA1c and BMI gains over 30 weeks

Source
Source: Hannon et al., the SURPASS-PEDS randomized, double-blind, placebo-controlled phase 3 trial of tirzepatide in children and adolescents with type 2 diabetes, published in Lancet in 2025.

Tirzepatide substantially improved blood sugar and BMI in youth with type 2 diabetes, with glycaemic benefit sustained through 1 year.

Design
Phase 3, randomized, double-blind trial
Population
99 participants aged 10 to <18 years
Background therapy
Inadequately controlled on metformin and/or basal insulin
Follow-up
Primary assessment at week 30; durability through week 52
Comparator
Placebo-controlled comparison

Why it matters

Youth-onset type 2 diabetes has limited treatment options and is often harder to control than adult-onset disease. Therapies that improve both glycaemia and weight-related measures may address two linked clinical priorities in adolescents.

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

Central efficacy visual: HbA1c change at week 30

Estimated treatment difference
−2.28 pp Pooled tirzepatide vs placebo for HbA1c change from baseline at week 30

Key findings

Glycaemic control
Pooled tirzepatide −2.23 pp
Placebo +0.05 pp
Estimated treatment difference −2.28 pp HbA1c at week 30
BMI reduction
−7.4% Tirzepatide 5 mg
−11.2% Tirzepatide 10 mg
−0.4% Placebo

Safety and durability

Adverse-event pattern

Most adverse events were mild-to-moderate gastrointestinal events, and decreased over time.

Discontinuations 2 Participants discontinued tirzepatide 5 mg due to adverse events.
Mortality 0 Deaths reported during the trial.
Durability 52 weeks Glycaemic benefit was sustained through 1 year.

Numbers to know

99 Participants aged 10 to <18 years
30 weeks Primary efficacy comparison
−2.23 pp HbA1c change with pooled tirzepatide
+0.05 pp HbA1c change with placebo
−11.2% BMI change with tirzepatide 10 mg
52 weeks Sustained glycaemic benefit observed
Tirzepatide appears to be a promising additional treatment option for adolescents with inadequately controlled type 2 diabetes, offering meaningful HbA1c and BMI improvements; use should include careful monitoring for gastrointestinal tolerability and continued long-term pediatric safety evaluation.
AbbreviationsQuick
Abbreviations: BMI = body mass index; CI = confidence interval; GLP-1 = glucagon-like peptide-1; HbA1c = glycated haemoglobin; SD = standard deviation; SURPASS-PEDS = trial name.
Bibliography1
  1. Hannon TS, Chao LC, Barrientos-Pérez M, Pamidipati KC, Landó LF, Lee CJ, et al. 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)