Eli Lilly says Mounjaro met all primary, secondary endpoints in Phase 3 trial

Eli Lilly (LLY) announced detailed results from SURPASS-PEDS, the first Phase 3 trial to evaluate the safety and efficacy of Mounjaro, a GIP/GLP-1 dual receptor agonist, in children and adolescents with type 2 diabetes inadequately controlled with metformin, basal insulin or both. At 30 weeks, Mounjaro met the primary and all key secondary endpoints, achieving superior improvements in A1C and body mass index compared to placebo. Results from the trial were presented at the European Association for the Study of Diabetes Annual Meeting 2025 and simultaneously published in The Lancet. “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,” said Tamara Hannon, M.D., director of the Clinical Diabetes Program, Indiana University School of Medicine and lead trial investigator. “The SURPASS-PEDS results show that Mounjaro delivered significant and clinically meaningful improvements in blood sugar, BMI and fasting serum glucose in pediatric patients. These results offer a promising opportunity to help shift the long-term health trajectory for young people living with this complex condition.” The trial met the primary endpoint of superior A1C reduction with Mounjaro 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 less than or equal to6.5%. 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.