Over the last six years, three GLP-1 drugs have been approved for children aged 10 and older with Type 2 diabetes. Now this rapidly growing patient population is a step closer to gaining access to Eli Lilly’s dual-action GLP-1/GIP treatment Mounjaro, as its effectiveness in controlling blood sugar has been demonstrated in a phase 3 trial of kids ages 10-17.
The Surpass-PEDS study—which enrolled 99 children with Type 2 diabetes who do not get adequate blood sugar control with metformin, insulin or a combination of both—achieved its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro provided improvements over placebo in the blood sugar measurement, A1C, and in patients' body mass index (BMI).
The study’s primary endpoint was accomplished, with Mounjaro-treated patients experiencing an average A1C reduction of 2.2% versus .05% for those on placebo from a mean baseline of 8.05%.
Lilly said that it has submitted the results to regulators in a bid to gain an expanded indication for the juggernaut diabetes medication.
“Youth living with type 2 diabetes often face a more aggressive disease course, and in many instances, first-line treatments like metformin and basal insulin fail to control their A1C adequately,” Tamara Hannon, M.D., the lead trial investigator and director of the Clinical Diabetes Program at the Indiana University School of Medicine, said in a release. “These results offer a promising opportunity to help shift the long-term health trajectory for young people living with this complex condition.”
As a secondary objective, 79% of patients on Mounjaro reduced their A1C to 6.5% or less, versus 28% of those on placebo. The 6.5% measure is a goal because those with an A1C at that level or higher are classified as having Type 2 diabetes.
As for BMI, patients on 5 mg and 10 mg doses of Mounjaro saw reductions of 7.4% and 11.2%, respectively, compared to 0.4% for those on placebo. The reductions were from a BMI mean baseline of 35.3.
Additionally, in the trial’s extension study, the reductions achieved in A1C and BMI were sustained through 52 weeks.
The overall safety profile of the treatment was generally consistent with the established incretin class, Lilly said. There were two patients—both on a 5 mg dose of Mounjaro—who discontinued treatment.
GLP-1 drugs previously approved for Type 2 diabetes patients age 10 and older include Novo Nordisk’s Victoza, Lilly’s Trulicity and AstraZeneca’s Bydureon. All were endorsed by the FDA between 2019 and 2022. Additionally, Novo’s GLP-1 treatments Saxenda and Wegovy received label expansions to treat obesity patients ages 12-17.
“Type 2 diabetes in children and teens is increasing at an alarming rate, yet treatment options are limited, and this patient population remains underserved,” Kenneth Custer, Ph.D., the president of Lilly Cardiometabolic Health, said in a statement.