A Research Study Comparing Active Drug in the Blood in Healthy Participants Following Dosing of the Current and a New Formulation (D) Semaglutide Tablets

What Was Tested

In this phase 1 trial, researchers set out to test Semaglutide.

In this study two different tablets for oral use of a known investigational medicinal product, called semaglutide, will be tested.

One is the current formulation and the other one is a new formulation of semaglutide.

Both will be administered as a tablet and are for the treatment of diabetes.

It had six arms (groups): Sequence 1 (experimental), Sequence 2 (experimental), Sequence 3 (experimental), Sequence 4 (experimental) and Sequence 5 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 274 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: Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive).

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: use of tobacco and nicotine products, defined as any of the below:; smoking more than 5 cigarettes or the equivalent per day; not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s).

How the Study Was Run

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

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

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

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

It started in 2019-09-30 with completion listed for 2020-12-16.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Cmax,sema,SS; maximum semaglutide plasma concentration at steady state, tmax,sema,SS; time to maximum semaglutide plasma contraction at steady state and t½,sema,SS; terminal half-life of semaglutide at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 274 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.