NOW APPROVED for pediatric patients 10 years of age and older with type 2 diabetes as an adjunct to diet and exercise to improve glycemic control
In pediatric patients 10 years of age and older with T2D1,2
Superior A1C reduction with Mounjaro vs placebo as an add-on to metformin and/or basal insulin at 30 weeks1
ap<0.001 for superiority vs placebo, adjusted for multiplicity.1
Treatment regimen estimand; mITT population.1,2
A1C=glycated hemoglobin; mITT=modified intent-to-treat; T2D=type 2 diabetes
In pediatric patients 10 years of age and older with T2D1,2
Superior BMI reduction with Mounjaro vs placebo as an add-on to metformin and/or basal insulin at 30 weeks1
Mounjaro is not indicated for weight loss.
In SURPASS-PEDS, percent change in BMI was a secondary endpoint. The primary endpoint of SURPASS-PEDS was change in A1C from baseline at 30 weeks.1,2
ap<0.001 for superiority vs placebo, adjusted for multiplicity.1
Treatment regimen estimand; mITT population.1,2
BMI=body mass index; mITT=modified intent-to-treat
Exploring Mounjaro Clinical Data for Pediatric Patients Aged 10 Years and Older With Type 2 Diabetes ||| fw-400
In pediatric patients 10 years of age and older with T2D1,2
Significantly more pediatric patients on Mounjaro achieved the ISPAD-recommended A1C target of ≤6.5%* vs placebo as an add-on to metformin and/or basal insulin at 30 weeks1,3
The primary endpoint of SURPASS-PEDS was change in A1C from baseline to 30 weeks with pooled Mounjaro (5 mg and 10 mg).1,2
*ISPAD recommends an A1C target of ≤6.5% when safely achievable for children and adolescents with diabetes who have access to advanced diabetes technologies like CGM and automated insulin delivery.3
ap<0.001 for superiority vs placebo, adjusted for multiplicity.1
Response in (%) is calculated by combining proportion of participants achieving target in imputed datasets using Rubin's rule.1
Treatment regimen estimand; mITT population.1,2
ISPAD=International Society for Pediatric and Adolescent Diabetes; CGM=continuous glucose monitoring
In pediatric patients 10 years of age and older with T2D1,2
Change in A1C and BMI from baseline to 52 weeks2
Mounjaro is not indicated for weight loss.
In SURPASS-PEDS, the primary endpoint was change in A1C from baseline at 30 weeks and percent change in BMI was a secondary endpoint.1,2. ||| mb-4
Analyses based on efficacy estimand data (on-treatment efficacy without the influence of rescue therapy) and may not represent a real-world setting.
In pediatric patients 10 years of age and older with T2D1,2
Common adverse events in a trial of Mounjaro vs placebo as an add-on to metformin and/or basal insulin2
Select Important Safety Information
https://main--ewi-mounjaro-aem-us--elilillyco.aem.page/fragments/sisi/acute-kidney-injury
In pediatric patients 10 years of age and older with T2D1,2
Incidence of hypoglycemia in a trial of Mounjaro vs placebo as an add-on to metformin and/or basal insulin1,2
Select Important Safety Information
https://main--ewi-mounjaro-aem-us--elilillyco.aem.page/fragments/sisi/hypoglycemia
https://main--ewi-mounjaro-aem-us--elilillyco.aem.page/fragments/hcp/peds-dark-page/peds-request-cta
SURPASS-PEDS Study Design ||| mb-0
- SURPASS-PEDS was a phase 3, double-blind, placebo-controlled trial that randomized (1:1:1) 99 pediatric patients 10 years of age and older with type 2 diabetes mellitus who had inadequate glycemic control on ≥1000 mg/day of metformin (69%), or basal insulin (8%), or both (23%) to receive SC Mounjaro 5 mg, Mounjaro 10 mg, or placebo once weekly as add-on therapy.1,2
- The primary objective was to demonstrate superiority of pooled Mounjaro (5 mg and 10 mg) to placebo in mean change from baseline in A1C at 30 weeks.2
- Key secondary objectives were assessed at 30 weeks for superiority of Mounjaro 5 mg and 10 mg individually vs. placebo: change from baseline in A1C, percentage of participants with A1C ≤6.5%, percent change in BMI.2
- Study participants were 10 to <18 years of age, had body weight ≥50 kg, BMI >85th percentile of the age- and sex-matched population, and had an A1C >6.5% to ≤11% at screening. Patients had a mean age of 14.7 years. The mean A1C was 8.0%, mean duration of T2D was 2.4 years, mean weight was 96.6 kg, and the mean baseline BMI was 35.4 kg/m2.1,2
- All patients in the Mounjaro treatment groups started on a dose of 2.5 mg once weekly, and the dose was escalated by 2.5 mg every 4 weeks until the target dose was reached. The 30-week double-blind period was followed by a 22-week open-label extension in which all participants received Mounjaro + metformin and/or basal insulin. In the open-label extension, participants in the placebo arm initiated Mounjaro 2.5 mg for 4 weeks and then continued on Mounjaro 5 mg for the remainder of the study (up to week 52).2
References
- Mounjaro. Prescribing Information. Lilly USA, LLC.
- Hannon TS, Chao LC, Barrientos-Pérez M, et al. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025;406(10511)(Incl suppl mat):1484-1496. doi:10.1016/S0140-6736(25)01774-X
- Shah AS, Zeitler PS, Wong J, et al. ISPAD clinical practice consensus guidelines 2022: type 2 diabetes in children and adolescents. Pediatr Diabetes. 2022;23(7):872-902. doi:10.1111/pedi.13409"