Evaluating Tirzepatide Compared to Placebo in Children With T2DM

Clinical Trial

Offered by: Nemours Children's
Location: Delaware Valley

Trial Name

Evaluating Tirzepatide Compared to Placebo in Children With T2DM

What is the trial about?

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.

Who can participate?

You can take part in this study if:

• You are 10 to 17 years old.
• You have type 2 diabetes.
• You are being treated with a diet and exercise program for type 2 diabetes.
• You are also taking metformin and/or long-acting insulin and your doses have been the same for at least the past 90 days prior to Visit 1 and until Visit 3.
• You have a high hemoglobin A1c (HbA1c) greater than 6.5% and no higher than 11% at screening visit.
• Your weight is at least 110 pounds (50 kg).
• You and your parent or legal guardian are able to fully participate in the activities of the study.

What is involved?

The overall study duration is approximately 60 weeks over 4 required study periods.

Part 1: This is not counted as study weeks of participation, but to decide if you can join the study. Your study doctor will talk to you, and some tests will be run to find out if you can take part in this study. This may take about 4 weeks. 

This part includes 2 visits. Procedures include talk about your medical history and vaccine history, have your vital signs measured, have an eye checkup, receive counselling on lifestyle management instruction, receive study e-diary and training on how to use it, and record entries in your e-diary.

Part 2: This part of the study will last about 30 weeks (7 months). Neither you nor the study doctor will know what study drug you are taking. Whether you receive a shot of tirzepatide or of placebo will be determined by chance. The chance that you will get tirzepatide is 2 in 3. Placebo is a shot that contains no active study drug.

This part includes 11 visits. Procedures include have a physical examination, have your vital signs measured, have an ECG, have a blood draw, provide a urine sample, record entries in your e-diary, complete questionnaires about your diabetes, receive counselling on lifestyle management instruction and receive first dose and training on self-administration of study drug.

Part 3: This part of the study will last for about 22 weeks (5 ½ months). During this period, everyone will take tirzepatide. You will know which dose of tirzepatide you are getting during this period.

This part includes 6 visits. Procedures include have a physical examination, have your vital signs measured, have an eye checkup, have an ECG, have a blood draw, provide a urine sample, record entries in your e-diary, complete questionnaires about your diabetes and receive counselling on lifestyle management instruction.

Part 4: This period will last 1 month after your study drug is stopped. There is 1 visit to the study site at the end of the period.

This part includes 1 visit. Procedures include have a physical examination, have your vital signs measured, have a blood draw, provide a urine sample and record entries in your e-diary.