Eli Lilly's Mounjaro Shows Promising Results in Pediatric Type 2 Diabetes Trial

Promising Insights from SURPASS-PEDS Trial on Mounjaro in Youth with Type 2 Diabetes

In a groundbreaking study, Eli Lilly and Company’s Mounjaro (tirzepatide), a dual GIP/GLP-1 receptor agonist, has demonstrated significant success in managing type 2 diabetes among children and adolescents. The results from the Phase 3 SURPASS-PEDS trial, presented at the European Association for the Study of Diabetes Annual Meeting 2025 and published in The Lancet, reveal substantial reductions in A1C levels and notable improvements in body mass index (BMI) for participants aged 10 to under 18 years who were inadequately controlled by current treatments.

The SURPASS-PEDS trial enrolled 99 participants across multiple countries, including the United States, Brazil, India, and Italy, assessing the efficacy and safety of Mounjaro over 30 weeks. Participants who received Mounjaro achieved an average A1C reduction of 2.2%, significantly outpacing those in the placebo group who saw almost negligible changes. Remarkably, 86.1% of the participants with the 10 mg dose reached the desirable A1C target of ≤ 6.5%. Additionally, BMI assessments indicated a significant average reduction of 11.2%, further highlighting Mounjaro's effectiveness.

Dr. Tamara Hannon from Indiana University's Clinical Diabetes Program, who led the trial, emphasized the urgent need for effective treatments for youth facing type 2 diabetes, particularly as traditional options often fail to achieve adequate glycemic control. “The SURPASS-PEDS results represent a hopeful advancement in diabetes management for our younger patients, providing them with a tool that can significantly improve their health trajectories,” Dr. Hannon noted.

The findings were particularly notable given that youth represent a demographic increasingly affected by type 2 diabetes, often encountering more aggressive disease progression. Mounjaro’s results displayed both clinically meaningful improvements in blood sugar control and weight management, critical components in reducing long-term health complications associated with diabetes.

Moreover, the safety profile of Mounjaro in pediatric patients was largely consistent with what has been observed in adult cohorts. Commonly reported adverse effects included gastrointestinal issues such as diarrhea, nausea, and vomiting—most of which were mild to moderate and occurred primarily during the initial dose escalation. Notably, the overall treatment discontinuation due to adverse effects was lower than expected, with zero severe hypoglycemia episodes reported.

Eli Lilly is moving forward by submitting the SURPASS-PEDS results to regulatory authorities in hopes of broadening the indications of Mounjaro for use in the pediatric population.