A Research Study Looking at the Comparability of 2 Different Forms of Oral Semaglutide in Healthy People

What Was Tested

This registered phase 1 trial tested Semaglutide.

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide.

The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.

The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.

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

Crossover arm.

Crossover arm.

Crossover arm.

The registry classes the interventions as drug.

Who Took Part

546 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 (BMI) between 21.0 and 32.0 kg/m\^2 (both inclusive).

The full record lists 2 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 within 48 hours prior to and during the inpatient periods.

How the Study Was Run

The set-up was 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.

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

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

It started in 2022-02-04 with completion listed for 2023-06-28.

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

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state.

It also tracked 2 secondary outcomes, for example tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 546 people.

With 546 participants it is a large trial for this field.

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.