Lilly's Mounjaro Shows Promise in Pediatric Type 2 Diabetes Trial

Eli Lilly's dual-action GLP-1/GIP treatment Mounjaro (tirzepatide) has demonstrated effectiveness in controlling blood sugar levels in children aged 10-17 with type 2 diabetes, according to results from a recent phase 3 trial. This development marks a significant step towards expanding treatment options for a rapidly growing patient population.

SURPASS-PEDS Trial Results

The SURPASS-PEDS study, which enrolled 99 children with type 2 diabetes inadequately controlled by metformin, insulin, or a combination of both, met its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro showed substantial improvements over placebo in both A1C levels and body mass index (BMI).

Key findings from the trial include:

• Mounjaro-treated patients experienced an average A1C reduction of 2.2% compared to 0.05% for those on placebo, from a mean baseline of 8.05%.
• 79% of patients on Mounjaro reduced their A1C to 6.5% or less, versus 28% of those on placebo.
• Patients on 5 mg and 10 mg doses of Mounjaro saw BMI reductions of 7.4% and 11.2%, respectively, compared to 0.4% for those on placebo, from a mean baseline BMI of 35.3.

Dr. Tamara Hannon, lead trial investigator and director of the Clinical Diabetes Program at the Indiana University School of Medicine, emphasized the significance of these results, stating, "These results offer a promising opportunity to help shift the long-term health trajectory for young people living with this complex condition."

Expanding Treatment Options for Pediatric Diabetes

The positive trial results for Mounjaro come at a critical time, as type 2 diabetes in children and adolescents continues to rise at an alarming rate. Over the past six years, three GLP-1 drugs have been approved for children aged 10 and older with type 2 diabetes, including Novo Nordisk's Victoza, Eli Lilly's Trulicity, and AstraZeneca's Bydureon.

Kenneth Custer, Ph.D., president of Lilly Cardiometabolic Health, highlighted the importance of addressing this growing health concern: "Type 2 diabetes in children and teens is increasing at an alarming rate, yet treatment options are limited, and this patient population remains underserved."

Eli Lilly has submitted the SURPASS-PEDS trial results to regulators in a bid to gain an expanded indication for Mounjaro. If approved, this dual-action GLP-1/GIP treatment could provide a valuable new option for managing type 2 diabetes in young patients who often face a more aggressive disease course and may not respond adequately to first-line treatments.