A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

What Was Tested

This registered phase 3 trial tested Tirzepatide.

The study will last approximately 90 weeks and may include up to 25 visits.

Participants who have completed the primary 72-week GPHP study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants will receive tirzepatide subcutaneously (SC).

Participants will receive placebo.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 160 actual participants took part.

It was open to people of any sex aged from 12 years up to 17 years.

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

Examples of who could join: Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR. Nonalcoholic fatty liver disease. Obstructive sleep apnea. Documented preexisting condition of Type 2 Diabetes.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: have type 1 diabetes; are prepubertal (tanner stage 1); have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men) syndrome type 2.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

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 2023-10-16 with completion listed for 2026-06-02.

It ran at 33 sites in United States (10), Israel (7), Czechia (5), Canada (4), Italy (4) and Poland (3).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change from Baseline in Body Mass Index (BMI) (time frame: Baseline, Week 72).

It also tracked 11 secondary outcomes, for example Change from Baseline in Body Weight, Change from Baseline in Waist Circumference, Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score, Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts, Change from Baseline in Systolic Blood Pressure and Change from Baseline in Diastolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 160 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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