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Plain-language guide to NCT06977438: phase 4 randomized trial of Semaglutide, 1020 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06977438
Phase
phase 4
Status
not yet recruiting
Start
2026-10-15
Completion (planned or actual)
2031-01-31
Participants
1020 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Obesity, Childhood
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Semaglutide.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

In this way, medications can unburden adolescents living with obesity, their caregivers, healthcare providers, health systems, and payors from the need to engage in and provide intensive HBLT.

Who Took Part

Enrollment: 1020 planned participants were the target.

It was open to people of any sex aged from 12 years up to 18 years.

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

Examples of who could join: Aged 12 to \< 18 years at screening. BMI \>/= 95th percentile based on age and sex at screening. Provide release of information for established primary health provider. Own a device capable of connecting to the virtual platform sessions with video.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: diabetes (type 1 or 2) due to safety concerns about proper surveillance of glycemic control virtually; current or recent (\< 6 months prior to screening) use of fda-approved obesity medications; previous metabolic/bariatric surgery or metabolic/bariatric surgery planned during the study period.

How the Study Was Run

The set-up was randomized, single-group and triple-blind.

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

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

Everyone received the same intervention, so there was no separate comparison group inside the trial.

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

It started in 2026-10-15 with completion listed for 2031-01-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 1020 people.

With 1020 participants it is a large trial for this field.

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

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

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.