Design
Phase 3, randomized, double-blind, placebo-controlled
Population
99 adolescents aged 10 to <18 years
Primary duration
Week 30 efficacy assessment; glycaemic benefit sustained through 52 weeks
Background therapy
Metformin and/or basal insulin; tirzepatide versus placebo
Central efficacy finding
−2.28%
Estimated treatment difference in HbA1c versus placebo at week 30
−2.87 to −1.69
95% CI
p<0.0001
Superiority test
HbA1c change at week 30
Treatment effect with 95% CI
BMI reduction at week 30
Key findings
Study population
99
Participants aged 10 to <18 years with inadequately controlled type 2 diabetes on metformin and/or basal insulin
Glycaemic efficacy
−2.23 pp vs +0.05 pp
HbA1c change at week 30 with tirzepatide versus placebo; ETD −2.28%, 95% CI −2.87 to −1.69; p<0.0001
Safety profile
0 deaths
Most common adverse events were gastrointestinal, mild to moderate, and decreased over time
Numbers to know
−2.23 pp
HbA1c with tirzepatide at week 30
+0.05 pp
HbA1c with placebo at week 30
95% CI −2.87 to −1.69
Treatment-difference precision
p<0.0001
Statistical significance for HbA1c effect
−7.4%
BMI change with tirzepatide 5 mg
−11.2%
BMI change with tirzepatide 10 mg
−0.4%
BMI change with placebo
52 weeks
Sustained glycaemic benefit reported through follow-up
Tirzepatide showed strong glycaemic and weight-related benefits in adolescents with type 2 diabetes, with a safety profile consistent with adult studies. It could become an important future treatment option, while longer-term monitoring, real-world evidence, and careful tolerability assessment remain important.