Status:
COMPLETED
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
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type2 Diabetes
Diabetes Mellitus
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
Brief 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. ...
Eligibility Criteria
Inclusion
- 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% at screening
- Have body weight ≥50 kilogram (kg) 110 pounds and BMI of \>85th percentile of the general age and gender-matched population for that country or region.
Exclusion
- Have Type 1 diabetes mellitus (T1DM), or positive GAD65 or IA2 antibodies
- After the T2DM diagnosis, have a history of diabetic ketoacidosis or hyperosmolar syndrome
- Have had ≥1 episode of severe hypoglycemia and/or ≥1 episode of hypoglycemic unawareness within the last 6 months.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).
- Had chronic or acute pancreatitis any time prior to study entry
- Female participants who are pregnant or breast feeding or intending to become pregnant.
- Using prescription or over the counter medications for weight loss within 90 days of the screening visit.
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2025
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT05260021
Start Date
April 13 2022
End Date
January 28 2025
Last Update
September 26 2025
Active Locations (51)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Center Of Excellence in Diabetes and Endocrinology
Sacramento, California, United States, 95821
3
Rady Children's Hospital
San Diego, California, United States, 92123
4
Touro University California
Vallejo, California, United States, 94592