Research Study Comparing New Tablets of Semaglutide in New Doses, in Healthy People

What Was Tested

This registered phase 1 trial tested Semaglutide.

In this study a known investigational medicinal product called semaglutide will be tested in four different tablet versions.

In addition to semaglutide, the different tablet versions C, D, E and F contain different helping agents in different amounts.

All tablet versions have a helping agent called SNAC.

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

290 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 21.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive). Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (as declared by participant); presence or history (as declared by participant) of pancreatitis (acute or chronic).

How the Study Was Run

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

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

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

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

It started in 2020-09-29 with completion listed for 2022-02-25.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 9 secondary outcomes, for example Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS), Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS), Maximum semaglutide plasma concentration at steady state (Cmax,sema,SS), Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS), Time to maximum semaglutide plasma contraction at steady state (tmax,sema,SS) and Number of treatment-emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 290 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.