Lilly’s Mounjaro® (tirzepatide) Demonstrates Superior Glycemic And Weight Control In First Phase 3 Pediatric Type 2 Diabetes Trial

Eli Lilly and Company today announced detailed results from SURPASS-PEDS, the first Phase 3 trial to evaluate the safety and efficacy of Mounjaro® (tirzepatide) in children and adolescents (ages 10 to <18) with type 2 diabetes inadequately controlled with metformin, basal insulin, or both.

"Type 2 diabetes in children and teens is increasing at an alarming rate, yet treatment options are limited, and this patient population remains underserved. The SURPASS-PEDS results show Mounjaro delivered statistically significant improvements in A1C, BMI and other critical cardiometabolic risk factors, while maintaining a safety profile generally consistent with adult studies. By undertaking this research, we can better support children and adolescents living with this condition," said Kenneth Custer, Ph.D., executive vice president and president of Lilly Cardiometabolic Health. 

At 30 weeks, Mounjaro achieved its primary endpoint of superior A1C reduction compared to placebo, lowering A1C by an average of 2.2% from a baseline of 8.05%. In addition, 86.1% of participants randomized to the 10 mg dose of Mounjaro reached the target A1C of ≤6.5%. The therapy also demonstrated clinically meaningful improvements in body mass index (BMI), with the 10 mg dose reducing BMI by 11.2% on average at 30 weeks. Both A1C and BMI improvements were sustained through 52 weeks in the trial’s extension phase.

"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. 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,," said Tamara Hannon, M.D., director of the Clinical Diabetes Program, Indiana University School of Medicine and lead trial investigator. 

The safety profile of Mounjaro in SURPASS-PEDS was consistent with prior findings from the SURPASS program and the incretin class. The most common adverse events were mild-to-moderate gastrointestinal symptoms, including diarrhea (25% vs. 6% placebo), nausea (20% vs. 9%), and vomiting (14% vs. 3%), occurring primarily during dose escalation. No severe hypoglycemia was reported. Discontinuation rates due to adverse events were low (≤6% across dose groups).

Lilly has submitted the SURPASS-PEDS data to global regulatory agencies to support an expanded indication for Mounjaro in pediatric patients with type 2 diabetes.