A Research Study to Look at How Semaglutide Affects Gastric Emptying in People With Obesity

What Was Tested

The trial (phase 1) is built around Semaglutide.

This study will look at how the emptying of the participant's stomach after a meal is affected by semaglutide (a new medicine) compared to a "dummy" medicine.

In addition, the study will also look at the effect of semaglutide on the participant's appetite and energy intake.

Participants will either get semaglutide or "dummy" medicine - which treatment any participant gets is decided by chance.

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

Participants will receive placebo (semaglutide). The treatment period from first treatment (Day 1) to end of the treatment (Day 141) will be 20 weeks.

The registry classes the interventions as drug.

Who Took Part

72 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female, aged between 18 to 65 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 30.0 and 45.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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 2019-02-15 with completion listed for 2019-11-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: AUC0-5h,para: the area under the paracetamol concentration-time curve from 0 to 5 hours at steady state (time frame: 0 to 5 hours after standardised meal (day 142)).

It also tracked 9 secondary outcomes, for example AUC0-1h,para: the area under the paracetamol concentration-time curve from 0 to 1 hour at steady state, Cmax,para: the maximum observed paracetamol concentration from 0 to 5 hours, Tmax,para: the time of maximum observed paracetamol concentration from 0 to 5 hours, Energy intake during ad libitum lunch, Mean postprandial rating - Fullness (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal and Mean postprandial rating - Satiety (AUC30-300min/270 min) using VAS from 30 up to 300 minutes during standardised breakfast meal.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 72 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.