A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III

What Was Tested

The trial (phase 1) is built around Semaglutide.

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

The two tablets differ in the way these have been manufactured.

It had two arms (groups): Sequence 1: Semaglutide J then Semaglutide K (experimental) and Sequence 2: Semagultide K then Semaglutide J (experimental).

Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.

Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 121 actual participants took part.

It was open to men only 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 22.0 and 31.9 kilograms per meter square (kg/m\^2) (both inclusive) at screening.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to study intervention(s) or related products; any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

How the Study Was Run

Design: randomized, crossover 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.

Each person switched between Semaglutide and the comparison at some point, usually with a gap in between.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2023-09-28 with completion listed for 2024-02-22.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve.

It also tracked 3 secondary outcomes, for example Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration, Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration and t½,sema; the terminal half-life of semaglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 121 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.