Trial Investigating the Effect of Semaglutide on Energy Intake, Appetite Sensations, Postprandial Glucose and Triglyceride Metabolism and Gastric Emptying in Obese Subjects Compared With Placebo

What Was Tested

This registered phase 1 trial tested Semaglutide.

This trial is conducted in Europe.

The aim of the trial is to investigate the effect of semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride metabolism and gastric emptying in obese subjects compared with placebo.

It had two arms (groups): Sema (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 actual participants took part.

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

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

Examples of who could join: Male or female, age above or equal to 18 years at the time of signing informed consent. A BMI (body mass index) between 30-45 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol; diagnosis of type 1 or 2 diabetes mellitus; anticipated change in lifestyle (e.g. eating, exercise or sleeping pattern) during the trial.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

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

Those kept unaware of assignments: participant and investigator.

It started in 2014-03-06 with completion listed for 2015-01-07.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Ad libitum energy intake during a lunch meal (following a standardised breakfast meal) (time frame: After 12 weeks of treatment).

It also tracked 5 secondary outcomes, for example Incremental area under the 0-300 minutes glucose profile (iAUC0-300min,Glucose) following intake of a standardised breakfast meal, Incremental area under the 0-480 minutes triglyceride profile (iAUC0-480min,TG) following intake of a standardised fat-rich meal and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 30 people.

Its size is small, so on its own it can only give an early look.

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.