A Research Study of How the Medicine NNC0480-0389 Taken With Semaglutide Works in the Body of Healthy Japanese Men

What Was Tested

The trial (phase 1) is built around Semaglutide.

This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide.

NNC0480-0389 is a new medicine that has not been previously approved.

It had six arms (groups): one (experimental), one (placebo comparator), one (experimental), one (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

It was open to men only aged from 20 years up to 55 years.

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

Examples of who could join: Male aged 20-55 years (both inclusive) at the time of signing the informed consent. Both parents of Japanese descent. Body mass index between 20.0 kg/m\^2 and 24.9 kg/m\^2 (both inclusive).

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise subject'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

It was run as a randomized, parallel-group and quadruple-blind study.

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

The Semaglutide group and the comparison group ran side by side rather than switching.

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 2021-05-18 with completion listed for 2021-07-20.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment emergent adverse events (TEAEs).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 24 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.