A Research Study to Look at Similarity Between Semaglutide Versions in Different Injection Tools

What Was Tested

This registered phase 1 trial tested Semaglutide.

This study will compare four different semaglutide versions and different injection tools.

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

The researchers also want to look at how well the injection tools work.

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

The registry classes the interventions as device and drug.

Who Took Part

Enrollment: 68 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 29.9 kg/m\^2 (both inclusive).

The full record lists 3 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; female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly affective contraceptive methods.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

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

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

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

It started in 2018-07-23 with completion listed for 2019-01-17.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example tmax,sema,SD, time to Cmax,sema,SD of semaglutide, t½,sema,SD, terminal elimination half-life of semaglutide, Cl/F,sema,SD, total apparent clearance of semaglutide and Vz/F,sema,SD, apparent volume of distribution of semaglutide.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 68 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.