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Eli Lilly’s diabetes drug Mounjaro (tirzepatide) is moving closer to approval for children and teens after strong results from a new clinical trial. The phase 3 SURPASS-PEDS study tested the drug in 99 patients ages 10 to 17 who struggled to control their blood sugar with common treatments like metformin and insulin.
After 30 weeks, kids taking Mounjaro saw major improvements compared to those on a placebo. Their average A1C levels—a key blood sugar measure—dropped by 2.2%, while the placebo group only dropped by 0.05%. Almost 80% of Mounjaro patients reached an A1C of 6.5% or less, the threshold for diagnosing type 2 diabetes, compared with only 28% of those on placebo.
Mounjaro also helped with weight management. Patients on the 5 mg dose reduced their body mass index (BMI) by 7.4%, while those on 10 mg reduced BMI by 11.2%. In contrast, the placebo group saw almost no change. These improvements lasted through a 52-week extension study.
Dr. Tamara Hannon, lead investigator of the trial, explained that young people with type 2 diabetes often have a more aggressive form of the disease, and current first-line treatments often don’t work well enough. She said the results are “a promising opportunity to shift the long-term health trajectory” for these patients.
The safety profile of Mounjaro was consistent with similar diabetes drugs, though two patients on the 5 mg dose stopped treatment.
If approved, Mounjaro would join other GLP-1 treatments already cleared for children, including Victoza, Trulicity, and Bydureon, as well as Novo Nordisk’s Saxenda and Wegovy for obesity. With type 2 diabetes rising quickly among youth, Mounjaro could provide an important new option.
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