INDIANAPOLIS (dpa-AFX) - Eli Lilly and Co. (LLY) announced detailed results from SURPASS-PEDS, the first Phase 3 trial evaluating the safety and efficacy of Mounjaro (tirzepatide)-a GIP/GLP-1 dual receptor agonist-in children and adolescents (ages 10 to under 18) with type 2 diabetes inadequately controlled by metformin, basal insulin, or both. At 30 weeks, Mounjaro met its primary and all key secondary endpoints, demonstrating sustained improvements in glycemic control and continued body mass index (BMI) reduction through the trial's 52-week extension. The safety and tolerability profile was generally consistent with findings from previous adult studies.
According to the company, the trial met the primary endpoint of superior A1C reduction with Mounjaro (pooled doses) compared to placebo at 30 weeks, lowering A1C by an average of 2.2% from an average baseline of 8.05% using the efficacy estimand.
In a key secondary endpoint, 86.1% of participants randomized to the 10 mg dose of Mounjaro achieved a target A1C of ?6.5%. In addition, Mounjaro showed clinically meaningful improvements in BMI, a measure that assesses weight changes in children and adolescents, accounting for their growth over time. The 10 mg dose of Mounjaro reduced BMI by 11.2% on average at 30 weeks. Improvements in A1C and BMI reductions continued through 52 weeks in the trial's long-term extension.
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