Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05260021 | 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 | PHASE3 | COMPLETED | 99 | — | — | Apr 13, 2022 | Jan 28, 2025 | Sep 26, 2025 | 51 | United States, Australia +7 |
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by ANCOVA model for endpoint measures: Variable = Baseline + Baseline Antihyperglycemic medication + Baseline Age group + Treatment (Type III sum of squares)
| Arm | Type | Description |
|---|---|---|
| Tirzepatide Dose 1 | EXPERIMENTAL | Double-Blind: Participants receive Tirzepatide by weekly subcutaneous (SC) injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level |
| Tirzepatide Dose 2 | EXPERIMENTAL | Double-Blind: Participants receive Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 2 is reached. Open-Label: Participants will continue to receive Tirzepatide at the last dose level |
| Placebo | PLACEBO_COMPARATOR | Double-Blind: Participants receive placebo during the 30-week double-blind period. Open-Label: Participants will switch to Tirzepatide by weekly SC injection starting with a low dose then increase to a higher dose every four weeks until maintenance dose level 1 is reached. |
| Name | Type | Description |
|---|---|---|
| Tirzepatide Dose 1 | DRUG | Administered SC |
| Tirzepatide Dose 2 | DRUG | Administered SC |
| Placebo | DRUG | Administered SC |
Inclusion Criteria: * Male or female, aged 10 to below 18 years at screening visit * Have type 2 diabetes, treated with diet and exercise and metformin and/or basal insulin. Metformin and/or basal insulin dose must be stable for at least 90 days prior to study screening. * Have HbA1c \>6.5% to ≤11%...