A Research Study to Compare Two Forms of Semaglutide in Two Different Pen-injectors in People With Overweight or Obesity

What Was Tested

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

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

None of the two forms of semaglutide have been approved by the authorities to treat obesity.

Participants will get 1 of the 2 forms of semaglutide - which one is decided by chance.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 29 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 27.0 and 34.9 kg/m\^2 (both inclusive). Body weight between 70.0 and 130.0 kg (both inclusive).

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; inability or unwillingness to perform self-injection.

How the Study Was Run

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

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.

Being open-label, the Semaglutide study did not mask who received what.

It started in 2019-07-15 with completion listed for 2019-08-30.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: AUC0-168h,[amount hidden],SS: Area under the semaglutide concentration time curve following the last administration of semaglutide s.c. [amount hidden]. Cmax,[amount hidden],SS: Maximum observed semaglutide concentration following the last administration of semaglutide s.c. [amount hidden].

It also tracked 10 secondary outcomes, for example Change in body weight.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 29 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.