Lilly’s Mounjaro Shows Strong Results in Youth Type 2 Diabetes, Paving Way for Expansion
A phase 3 clinical trial (SURPASS-PEDS) showed that Mounjaro (tirzepatide) significantly reduced hemoglobin A1C by an average of 2.2% at 30 weeks in children and adolescents (ages 10-17) with type 2 diabetes inadequately controlled with metformin or basal insulin1.
At the 10 mg dose, 86.1% of participants achieved the recommended A1C target (≤6.5%), and average BMI fell by 11.2% at 30 weeks; improvements in both A1C and BMI continued through 52 weeks1.
The trial included 99 youths from multiple countries and met all primary and key secondary endpoints, confirming both efficacy and a safety/tolerability profile consistent with adult studies1.
Mounjaro's safety profile involves risks such as possible thyroid C-cell tumors (black box warning), gastrointestinal side effects, pancreatitis, and contraindications in certain conditions (e.g., personal/family history of medullary thyroid carcinoma), according to FDA labeling2.
Results from the SURPASS-PEDS trial were presented at the European Association for the Study of Diabetes Annual Meeting 2025 and published in The Lancet, indicated significant promise for expanding treatment options for youths with type 2 diabetes, a growing but underserved group1.
Sources:
1. https://www.prnewswire.com/news-releases/lillys-mounjaro-tirzepatide-a-gipglp-1-dual-receptor-agonist-reduced-a1c-by-an-average-of-2-2-in-a-phase-3-trial-of-children-and-adolescents-with-type-2-diabetes-302559576.html
2. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/eli-lilly-and-company-716485-09092025