Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05260021 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 99
- Enrollment target
NCT05260021: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT05260021 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 99 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05260021, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 99 participants
- Enrollment target
Study Summary
The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.
Primary Outcome
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)
Interventions
- DRUG Placebo
- DRUG Tirzepatide Dose 1
- DRUG Tirzepatide Dose 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 99 participants |
| Start Date | 2022-04-13 |
| Est. Completion | 2025-01-28 |
| Phase | Phase 3 |
What the finished NCT05260021 record still lists
NCT05260021 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 99 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05260021 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05260021 about?
NCT05260021 is a clinical study 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". The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic vi...
What is the current status of trial NCT05260021?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 99 participants. The study started on 2022-04-13. Estimated completion is 2025-01-28.
What interventions are being tested in trial NCT05260021?
The interventions under investigation include: Placebo (DRUG), Tirzepatide Dose 1 (DRUG), Tirzepatide Dose 2 (DRUG).
Who is sponsoring clinical trial NCT05260021?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05260021's enrollment target sits among peer trials
99 1713th of 2000 higher than 287 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03965234 · 99 participants · Phase 1
Pulmonary Suffusion in Controlling Minimal Residual Disease in Patients With Sarcoma or Colorectal Metastases
- NCT04022616 · 99 participants
Myeloid-Derived Suppressor Cell Function in Breast Cancer Patients
- NCT04042844 · 99 participants · Phase 2
A Single Dose of BRTX 100 for Patients With Chronic Lumbar Disc Disease (cLDD)
- NCT04143724 · 99 participants · Phase 2
Study of Safety & PK of Luspatercept (ACE-536) in Pediatric Participants With Beta (β)-Thalassemia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI