Comparing Semaglutide Administered Subcutaneously Once Daily to Semaglutide Administered Subcutaneously Once Weekly

What Was Tested

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

This trial is conducted in Europe.

The aim of this trial is to compare the steady-state exposure of semaglutide administered subcutaneously once daily to semaglutide administered subcutaneously once weekly in healthy subjects.

It had three arms (groups): semaglutide OD + placebo semaglutide OW (experimental), placebo semaglutide OW + placebo semaglutide OD (placebo comparator) and semaglutide OW + placebo semaglutide OD (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 113 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Male or female, aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol; history of pancreatitis (acute or chronic); screening calcitonin equal or above 50 ng/l.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2015-09 with completion listed for 2016-04.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the semaglutide concentration-time curves.

It also tracked 4 secondary outcomes, for example Maximum observed semaglutide plasma concentration and Number of treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 113 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.