A Research Study Looking at Similarity Between Once-weekly Semaglutide Versions for Different Injection Pens

What Was Tested

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

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

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

Participants will get 1 of the 2 versions of semaglutide.

It had two arms (groups): DV3396 (experimental) and PDS290 (experimental).

Semaglutide administered with the DV3396 pen-injector (semaglutide D, test formulation).

Semaglutide administered with the PDS290 pen-injector (semaglutide reference formulation).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 68 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent. Body mass index between 25.0 and 34.9 kg/m\^2 (both inclusive) and. Body weight between 65.0 and 130.0 kg (both inclusive).

The full record lists 4 inclusion and 9 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; abuse or intake of alcohol, defined as any of the below:; positive alcohol test at screening.

How the Study Was Run

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

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

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

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2019-11-25 with completion listed for 2020-05-25.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

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.