A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide

What Was Tested

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

The study will look at how two different versions of semaglutide reach and stay in the blood after injection.

The study aims to show similar levels of semaglutide in the blood when using the different versions.

Participants will get both versions of semaglutide.

It had two arms (groups): one (experimental) and one (experimental).

Semaglutide administered with the PDS290 pen-injector.

Semaglutide administered with the PDS290 pen-injector.

The registry classes the interventions as drug.

Who Took Part

28 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 between 20.0 and 27.0 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 2 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.

How the Study Was Run

The set-up was randomized, crossover and quadruple-blind.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Semaglutide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-01-29 with completion listed for 2020-06-01.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the semaglutide plasma concentration curve from 0 to tz (time frame: 0-840 hours). Maximum semaglutide plasma concentration (time frame: 0-840 hours).

It also tracked 5 secondary outcomes, for example Area under the semaglutide plasma concentration curve, Time to Cmax for semaglutide, Terminal elimination half-life, Total apparent clearance of semaglutide and Apparent volume of distribution of semaglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 28 people.

Its size is small, so on its own it can only give an early look.

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.