Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects

What Was Tested

The trial (phase 1) is built around Semaglutide.

This trial is conducted in Europe.

It had three arms (groups): Fed conditions (experimental), Fasting conditions (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

78 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Male or female subject aged 18-75 years (both inclusive) at the time of signing informed consent. Body mass index of 18.5-29.9 kg/m\^2 (both inclusive). A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: not able or not willing to refrain from smoking or use of nicotine substitute products when staying at the clinical unit.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

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

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

It started in 2014-06 with completion listed for 2014-10.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the semaglutide plasma concentration time curve.

It also tracked 4 secondary outcomes, for example Maximum observed semaglutide plasma concentration, Time to maximum observed semaglutide plasma concentration, Terminal half-life of semaglutide and Area under the SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) plasma concentration time curve.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 78 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.