Young Adults With Early-onset Obesity Treated With Semaglutide

What Was Tested

In this phase 4 trial, researchers set out to test Semaglutide.

Currently available treatment options consist of structured lifestyle interventions.

It had five arms (groups): Non-responders: TCOC+ semaglutide (active comparator), Non-responders: TCOC+ placebo (placebo comparator), Insufficient responders: TCOC+ semaglutide (active comparator), Insufficient responders: TCOC+ placebo (placebo comparator) and Excellent Responders and Population-based reference group (no intervention).

The registry classes the interventions as behavioral and drug.

More on the Plan

Thus, adolescents with obesity require particular medical attention.

This indicates that GLP-1 RAs can overrule lifestyle modification-resistant obesity due to the appetite-inhibiting effect.

A new GLP1-1 RA (semaglutide) was approved by the European Medical Agency (EMA) for weight management in adults with obesity in January 2022.

Thus, semaglutide has a potentially larger treatment effect also in young adults with childhood onset obesity.

Who Took Part

The registry lists 246 actual participants took part.

It was open to people of any sex aged from 18 years up to 28 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 18-28 years. The period from the initial treatment with TCOC protocol until inclusion in the study must be within 15 years.

The full record lists 6 inclusion and 16 exclusion criteria; among the exclusions: angina pectoris, coronary heart disease, congestive heart failure (nyha iii-iv); severe hepatic impairment; inflammatory bowel disease.

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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 Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2022-05-30 with completion listed for 2026-04-01.

It ran at 2 sites in Denmark (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in BMI (weight in kg/height in m^2) (time frame: Change from baseline to end-of-treatment (68 weeks)).

It also tracked 9 secondary outcomes, for example Change in body composition (fat mass), Change in body composition (fat percentage), Change in body composition (fat free mass), Change in visceral fat and liver fat, Change in metabolic syndrome and Change in waist-to-height ratio.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 246 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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