Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

What Was Tested

In this phase 1 trial, researchers set out to test Tirzepatide and Semaglutide for fat loss, obesity & body recomposition.

The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old.

The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone.

The study also plans to learn more about whether a medication (semaglutide or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.

It had three arms (groups): Observational (no intervention), Active Medication + Standard Postoperative Care (experimental) and Standard Postoperative Care (active comparator).

Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 6 months postoperatively.

Participants can be enrolled between 6 to 24 months postoperatively and will receive usual interdisciplinary postoperative care.

The registry classes the interventions as behavioral and drug.

Who Took Part

40 planned participants were the target.

It was open to people of any sex aged from 12 years up to 24 years.

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

Examples of who could join: Signed and dated informed consent form. Willingness to comply with all study procedures and availability for the duration of the study. Male or female biological sex, age 12 through 24 years. In the preoperative pathway for vertical sleeve gastrectomy.

The full record lists 4 inclusion and 40 exclusion criteria; among the exclusions: planned roux-en-y gastric bypass; hypothalamic obesity; type 2 diabetes.

How the Study Was Run

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

The fat loss, obesity & body recomposition participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

In this single-blind Tirzepatide study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2024-10-11 with completion listed for 2027-09-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA) (time frame: Baseline, 6 months postoperatively). Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry (time frame: Baseline, 6 months postoperatively). Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram (time frame: Baseline, 6 months postoperatively).

It also tracked 21 secondary outcomes, for example Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA), Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry, Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram, Intervention Phase: Eligibility rate, Intervention Phase: Enrollment rate and Intervention Phase: Retention rate.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Tirzepatide and Semaglutide in 40 people with fat loss, obesity & body recomposition.

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

More context: the Tirzepatide compound page and the Semaglutide compound page, Fat loss, obesity & body recomposition research.