A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

What Was Tested

This registered phase 1 trial tested Tirzepatide.

The main purpose of this study is to evaluate the safety and tolerability of tirzepatide (LY3298176) in pediatric participants with obesity.

The blood tests will be performed to investigate how the body processes the study drug in these participants.

For each participant, the study will last about approximately 13 weeks excluding the screening period.

It had six arms (groups): Cohort 1: Placebo (BW >=50 kg) (placebo comparator), one (experimental), Cohort 2: Placebo (BW <50 kg) (placebo comparator), one (experimental) and Cohort 3: Placebo (BW 40 to 60 kg) (placebo comparator).

Participants in this cohort had a screening body weight (BW) of at least 50 kilograms (kg) received placebo administered subcutaneously (SC) once weekly (QW) during Weeks 1 to 8.

Participants in this cohort had a screening body weight less than 50 kg received placebo administered SC QW during Weeks 1 to 8.

The registry classes the interventions as drug.

Who Took Part

The registry lists 28 actual participants took part.

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: Male and female participants with body mass index (BMI) ≥ the 95th percentile for age and sex. Have failed to achieve adequate weight loss through lifestyle modification in the investigator's opinion. Female participants only: Determined as prepubertal Tanner Stage 1.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records; have obesity induced by other endocrinologic disorders (for example, cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity; have acute or chronic pancreatitis or a history of acute idiopathic pancreatitis; or have other gi disorders.

How the Study Was Run

The set-up was 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.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2023-02-07 with completion listed for 2025-01-16.

It ran at 3 sites in United States (3).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) (time frame: Baseline through Week 14).

It also tracked 2 secondary outcomes, for example PK: Maximum Concentration (Cmax) of Tirzepatide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide in 28 people.

Its size is small, so on its own it can only give an early look.

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.