Trial results for a Phase 3 study (NCT05260021) investigating tirzepatide in pediatric and adolescent participants with Type 2 Diabetes Mellitus were posted on ClinicalTrials.gov on 2025-09-26. The study showed that pooled doses of tirzepatide (5 mg and 10 mg) resulted in a least squares mean change from baseline in HbA1c of -2.03 percentage of HbA1c, compared to -0.23 percentage of HbA1c for placebo.
Background
The study aimed to evaluate tirzepatide in pediatric and adolescent participants with Type 2 Diabetes Mellitus inadequately controlled with metformin or basal insulin or both.
Trial design
The study (NCT05260021) was a Phase 3, completed trial that enrolled 99 participants. It investigated tirzepatide in pediatric and adolescent participants diagnosed with Type 2 Diabetes Mellitus. Participants were taking metformin, basal insulin, or both, and had inadequately controlled diabetes. The interventions included tirzepatide dose 1, tirzepatide dose 2, and placebo.
Key results
The trial results demonstrated significant improvements in glycemic control and BMI standard deviation scores with tirzepatide compared to placebo.
For the outcome "Change From Baseline in Hemoglobin A1c (HbA1c)":
- Pooled doses of tirzepatide (5 mg and 10 mg) showed a least squares mean change of -2.03 percentage of HbA1c (Standard Error: 0.165).
- The placebo group showed a least squares mean change of -0.23 percentage of HbA1c (Standard Error: 0.229).
- Individually, 5 mg tirzepatide resulted in a change of -1.90 percentage of HbA1c (Standard Error: 0.236), and 10 mg tirzepatide resulted in a change of -2.16 percentage of HbA1c (Standard Error: 0.232).
Analysis of the least squares mean difference (Final Values) between pooled tirzepatide doses and placebo for HbA1c change was -1.8 (95.0% CI: -2.35 to -1.25) with a p-value of 0.001.
Regarding the "Percentage of Participants Who Achieve ≤6.5% of HbA1c":
- 73.6 percentage of participants in the pooled tirzepatide group achieved this target.
- This compared to 28.2 percentage of participants in the placebo group.
- Specifically, 66.4 percentage of participants on 5 mg tirzepatide and 80.6 percentage of participants on 10 mg tirzepatide achieved this target.
The Risk Difference (RD) for achieving ≤6.5% HbA1c for pooled tirzepatide doses versus placebo was 45.8 (95.0% CI: 27.5 to 64.1) with a p-value of 0.001.
For "Change From Baseline in Body Mass Index (BMI) Standard Deviation Score":
- Pooled doses of tirzepatide showed a least squares mean change of -0.60 Z-score (Standard Error: 0.050).
- Individual doses showed -0.45 Z-score (Standard Error: 0.072) for 5 mg tirzepatide and -0.76 Z-score (Standard Error: 0.072) for 10 mg tirzepatide.
What this means
The results from this Phase 3 trial indicate that tirzepatide significantly improved glycemic control, as evidenced by the substantial reduction in HbA1c and the higher proportion of pediatric and adolescent participants achieving an HbA1c of ≤6.5%, compared to placebo. The observed reduction in BMI standard deviation scores also suggests a beneficial effect on weight management in this population. These findings provide important data for clinicians considering treatment options for Type 2 Diabetes Mellitus in younger patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05260021, titled "A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both," were posted on 2025-09-26 on clinicaltrials.gov.