Eli Lilly posts late-stage trial win for Ozempic in children and adolescents with diabetes

[Lilly Biotechnology Center in San Diego, California, USA.]
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Eli Lilly (NYSE:LLY [https://seekingalpha.com/symbol/LLY]) has announced detailed results from a Phase 3 trial in which its GIP/GLP-1 dual receptor agonist, tirzepatide, marketed as Mounjaro, reached the primary endpoint in children and adolescents with type 2 diabetes.

Citing detailed data from the 99-patient global trial as presented at a European medical event and simultaneously published in the medical journal The Lancet, the Indiana-based drugmaker stated that Mounjaro met the primary and all key secondary endpoints in its SURPASS-PEDS study.

The popular injectable is already available in the U.S. for adults with type 2 diabetes, and marketed as Zepbound for obese adults or some overweight adults with at least one weight-related medical condition.

Based on a per-protocol analysis, the company noted that SURPASS-PEDS met the study’s main goal, as tirzepatide led to a 2.2% average decline in A1C, a key diabetes biomarker, outperforming the placebo, which caused an average A1C reduction of 0.05%.

Safety results were in line with the known tolerability profile of the gut hormone-based therapeutic class known as incretin drugs, Eli Lilly (NYSE:LLY [https://seekingalpha.com/symbol/LLY]) said, noting that, however, 3% of those in the on-drug arm discontinued the trial due to adverse events compared to none in the placebo arm.

The company added that it has filed SURPASS-PEDS data with multiple regulatory agencies worldwide to expand Mounjaro’s indication. [https://seekingalpha.com/pr/20236423-lillys-mounjaro-tirzepatide-a-gip-glpminus-1-dual-receptor-agonist-reduced-a1c-by-an-average]

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