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A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

Plain-language guide to NCT06041217: phase 3 randomized trial of Semaglutide, 242 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06041217
Phase
phase 3
Status
completed
Start
2023-09-15
Completion (planned or actual)
2025-04-02
Participants
242 (actual)
Design
randomized, quadruple-blind, treatment
Conditions studied
Overweight; Obesity
Results posted
yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Semaglutide.

This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo).

The study will last for about 1 year.

Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.

Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 242 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

The full record lists 6 inclusion and 5 exclusion criteria; among the exclusions: A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records; treatment with any medication for the indication of obesity within the past 90 days before screening; personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

How the Study Was Run

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

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

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

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

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

It started in 2023-09-15 with completion listed for 2025-04-02.

It ran at 21 sites in China (16) and Taiwan (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Body Weight (%) (time frame: Baseline (week 0), end of treatment (week 44)).

It also tracked 22 secondary outcomes, for example Change in Waist Circumference, Change in Body Weight (kg), Change in Body Mass Index, Change in Waist-height Ratio (WtHR), Change in Systolic Blood Pressure and Change in Diastolic Blood Pressure.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 242 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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.