First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.

What Was Tested

This registered phase 1 trial tested Glucagon.

The study is comparing the new medicine NNC9204-1513 with a standard therapy of glucagon (GlucaGen®).

This is the first time NNC9204-1513 is given to humans.

Participants will either receive NNC9204-1513 or GlucaGen® - which treatment you get is decided by chance (like flipping a coin).

It had two arms (groups): NNC9204-1513 (experimental) and Glucagon (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 36 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Male, aged 18 -55 years (both inclusive), at the time of signing informed consent. Body mass index (BMI) between 18.5 and 28.0 kg/sqm (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, evaluation of results, or compliance with the protocol.

How the Study Was Run

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

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

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

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

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

It started in 2018-02-05 with completion listed for 2018-05-24.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of treatment emergent adverse events (TEAEs).

It also tracked 26 secondary outcomes, for example Change from baseline in haematology, Change from baseline in biochemistry, Change from baseline in fibrinogen, Change from baseline in lipids, Change from baseline in glucose metabolism and Change from baseline in hormones.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glucagon in 36 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 Glucagon compound page, all human trials.