A Research Study to Compare How Much Semaglutide is Found in the Blood With Different Tablets of Oral Semaglutide in Healthy Participants

What Was Tested

This registered phase 1 trial tested Semaglutide.

In this study, a known investigational medicine called 'semaglutide' will be tested in 2 different tablet versions.

In addition to semaglutide, the tablet versions contain different helping agents in different amounts.

Both tablet versions have a helping agent called SNAC.

It had four arms (groups): Sequence A: Semaglutide J-Semaglutide C-Semaglutide J (experimental), Sequence B: Semaglutide C-Semaglutide J-Semaglutide J (experimental), Sequence C: Semglutide J-Semaglutide J-Semaglutide C (experimental) and Sequence D: Semaglutide J-Semaglutide C-Semaglutide J (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 264 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

How the Study Was Run

It was run as a randomized, sequential and open-label study.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2023-03-16 with completion listed for 2024-02-23.

It ran at 3 sites in United States (2) and Canada (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Cmax,0-24h.semaglutide,SS; maximum observed plasma concentration of semaglutide at steady state and tmax,0-24h,semaglutide,SS; Time to maximum semaglutide plasma concentration at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 264 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.