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The Effect of Weekly Semaglutide Treatment on Energy Expenditure
Plain-language guide to NCT06390501: not phased randomized trial of Semaglutide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06390501
- Phase
- not phased
- Status
- completed
- Start
- 2024-04-01
- Completion (planned or actual)
- 2025-08-15
- Participants
- 60 (actual)
- Design
- randomized, double-blind, basic_science
- Conditions studied
- Obesity; Drug
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Semaglutide.
After baseline testing, 52 patients will be randomly assigned to the semaglutide or matching placebo injection group.
In addition to taking medication or placebo, all participants will a calorie restricted diet provided by the researchers, providing 600 kcals per day below their estimated baseline requirements.
It had two arms (groups): Semaglutide (experimental) and Placebo (placebo comparator).
The registry classes the interventions as drug.
More on the Plan
Obesity is a complex chronic recurrent multifactorial disease characterized by abnormal or excessive body fat, which impairs physical health.
This effect has been proven to be produced by activating the glucagon like peptide-1 (GLP-1) receptors in the central nervous system, further indirectly regulating the activity of neurons involved in appetite regulation, food intake, and preference.
Whether the same effects occur in humans is unclear because no studies have yet been performed comparing semaglutide treated individuals with those on a standard calorie restricted diet (in effect pair feeding).
Who Took Part
The registry lists 60 actual participants took part.
It was open to women only aged from 18 years up to 60 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Age 18-60 years at time of enrollment. BMI ≥ 25 kg/m².
The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: weight change exceeding 5 kilograms (11 pounds) in the past 90 days; surgical treatment for past obesity, dieting, or undergoing weight loss treatment; irregular diet and lifestyle, unhealthy habits such as smoking, alcohol, and drugs.
How the Study Was Run
Design: randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.
The Semaglutide group and the comparison group ran side by side rather than switching.
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 and investigator.
It started in 2024-04-01 with completion listed for 2025-08-15.
It ran at 1 site in China.
Its stated primary purpose is basic science.
What Was Measured
The main thing measured (primary outcome): Changes of Total Energy Expenditure Assessed by Doubly Labeled Water Analysis (time frame: From baseline at week 0 to week 24). Changes of Energy Expenditure Assessed by Chamber (time frame: From baseline at week 0 to week 24). Changes of Resting Energy Expenditure (time frame: From baseline at week 0 to week 24).
It also tracked 54 secondary outcomes, for example Body Weight, Body Mass Index (BMI), Waist and Hip circumferences, Body shape, Fat mass and Far free mass.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Semaglutide in 60 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.
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.