A Research Study Looking Into Blood Levels of Semaglutide and NNC0480-0389 When Given in the Same Injection or in Two Separate Injections in Healthy People

What Was Tested

The trial (phase 1) is built around Semaglutide.

In this study, participants will receive semaglutide and NNC0480-0389 together at the same time.

Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new potential medicine.

Giving the medicines at the same time will be investigated once by using two separate syringes and once by using only one syringe containing both medicines ("co-formulation").

It had two arms (groups): NNC0480-0389 + semaglutide(co-formulation)and placebo (experimental) and NNC0480-0389 + semaglutide (separate injections) (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 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 of non-childbearing potential (NCBP), aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index (BMI) between 20.0 and 29.9 kg/m\^2 (both inclusive).

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol; presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

How the Study Was Run

Design: randomized, crossover 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.

In the crossover set-up each of the participants took both Semaglutide and the comparison in turn, acting as their own control.

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 2021-09-06 with completion listed for 2022-01-05.

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 16 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.