First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes

What Was Tested

The trial (phase 1) is built around Semaglutide.

This will be investigated in healthy participants, participants with high bodyweight and participants with type 2 diabetes (T2D).

NNC0480-0389 has not been given to humans before.

It had four arms (groups): NNC0480-0389 and semaglutide (experimental), NNC0480-0389 and placebo (semaglutide) (experimental), Placebo (NNC0480-0389) with semaglutide (active comparator) and Placebo (NNC0480-0389) with placebo (semaglutide) (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

152 actual participants took part.

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Male aged 18-45 years (both inclusive) at the time of signing informed consent. Body mass index between 20.0 kg/m\^2 and 29.9 kg/m\^2 (both inclusive). Body mass index between 20.0 kg/m\^2 and 39.9 kg/m\^2 (both inclusive). Female of non-childbearing potential or male aged 18-55 years (both inclusive) at the time of signing informed consent. Body mass index between 25.0 kg/m\^2 and 39.9 kg/m\^2 (both inclusive). Overweight or obesity should be due to excess adipose tissue, as judged by the investigator.

The full record lists 12 inclusion and 11 exclusion criteria; among the exclusions: any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; use of any prohibited medications as listed in the protocol within 14 days of screening.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

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 2020-02-17 with completion listed for 2022-03-16.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment emergent adverse events (TEAE) in Part 1. Number of treatment emergent adverse events (TEAE) in Part 2.

It also tracked 8 secondary outcomes, for example Area under the NNC0480-0389 plasma concentration-time curve from time.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 152 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.