GLP-1 Analogue Effects on Food Cues, Stress, Motivation for Highly Palatable Foods, and Weight

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

To examine response to a glucagon-like peptide-1 analogue vs. placebo in patients with obesity and assess impact on craving, hunger, stress, and weight outcomes.

It had two arms (groups): GLP-1a (experimental) and Placebo (placebo comparator).

Placebo pen administered weekly over 12 weeks.

The registry classes the interventions as drug and other.

Who Took Part

96 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: BMI ranging from 30-49.9 kg/m2. English speaking and able to read English and complete study evaluations. Able to provide informed written and verbal consent.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: taking any other anti-obesity medication; history of pancreatitis, medullary thyroid cancer, or men syndrome, or (6) women who are pregnant or lactating, or peri/postmenopausal.

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.

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 2021-02-01 with completion listed for 2024-11-19.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Change in Craving Score. Change in Hunger Score (time frame: Average change in hunger VAS rating from week 0 and end of study week 12 (week 12 VAS - Week 0 VAS)). Change in Food Intake.

It also tracked 2 secondary outcomes, for example Change in Food Intake - Real-World and Change in Stress Score.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 96 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.