A Trial to Compare Blood Concentration Levels of Semaglutide Following Subcutaneous Injections of Semaglutide [amount hidden] by 2 Different Devices (the DV3372 Device and by the PDS290 Semaglutide Pen-injector)

What Was Tested

The trial (phase 1) is built around Semaglutide.

This study compares semaglutide in two different injection tools called "PDS290" and "DV3372".

The study aims to show similar levels of semaglutide in the blood when using either of the two injection tools.

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

It had two arms (groups): DV3372 device (experimental) and PDS290 semaglutide pen-injector (active comparator).

Participants will receive semaglutide on day 1, 8, 15, 22 and 29. The treatment period from first treatment (Day 1) to end of the treatment (Day 29) will be 4 weeks.

Participants will receive semaglutide on day 1, 8, 15, 22 and 29. The treatment period from first treatment (Day 1) to end of the treatment (Day 29) will be 4 weeks.

The registry classes the interventions as device and drug.

Who Took Part

The registry lists 54 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.

The full record lists 0 inclusion and 1 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

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

It started in 2018-08-08 with completion listed for 2019-01-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Number of site-initiated technical complaints with or without co-reported adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 54 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.