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

What Was Tested

This registered phase 3 trial tested Tirzepatide.

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.

It had three arms (groups): one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 99 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, aged 10 to below 18 years at screening visit. 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.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2022-04-13 with completion listed for 2024-07-30.

It ran at 51 sites in United States (13), Brazil (11), India (6), Israel (5), Mexico (5) and Australia (3).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (Age and Sex-matched), Change From Baseline in Fasting Serum Glucose (FSG), Percent Change From Baseline in BMI, Percent Change From Baseline for Serum Lipid Levels, Change From Baseline in Height Standard Deviation Score (SDS) and Change From Baseline in Weight SDS.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 99 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Tirzepatide compound page, all human trials.