Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)

What Was Tested

This registered phase 3 trial tested Tirzepatide.

Participation in the study will last about 104 weeks.

Participants who have completed the primary 104-week PW02 study (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 SC.

The registry classes the interventions as drug.

Who Took Part

150 planned participants were the target.

It was open to people of any sex aged from 6 years up to 11 years.

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

Examples of who could join: Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive). A body weight of ≥ 40 kilograms (kg) (88 pounds), and. Been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart. Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \[CDC-NCHS, 2022\]).

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: have a history of; proliferative diabetic retinopathy; diabetic macular edema, or.

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.

The Tirzepatide group and the comparison group ran side by side rather than switching.

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 2026-09-25 with completion listed for 2029-12.

It ran at 82 sites in United States (41), Poland (8), Israel (6), Spain (6), Italy (5) and Mexico (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change from Baseline in Body Mass Index (BMI) (time frame: Baseline, Week 84).

It also tracked 13 secondary outcomes, for example Change from Baseline in Body Weight, Change from Baseline in Waist Circumference, Change from Baseline in Blood Pressure, Percent Change from Baseline in Total Cholesterol, Change from Baseline in Fasting Glucose and Percent Change from Baseline in Fasting Insulin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 150 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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