Investigate Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-0530 Alone and in Combination With Liraglutide in Overweight to Obese But Otherwise Healthy Male Subjects

What Was Tested

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

This trial is conducted in the United States of America (USA).

It had two arms (groups): Part 1 (experimental) and Part 2 (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 163 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, age between (both inclusive) 18 and 55 years at the time of signing inform consent. Overweight or obese but otherwise healthy male subjects; BMI of between or equal to 27.0 and 35.0 kg/m\^2.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: thyroid stimulating hormone values outside 0.4-6.0 miu/l; A history of additional risk factors for Torsades de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome); the use of concomitant medications that prolong the qt/qtc interval.

How the Study Was Run

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

The participants were allocated by chance, so the Liraglutide 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 Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2014-09-04 with completion listed for 2016-07-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of treatment emergent adverse events recorded.

It also tracked 4 secondary outcomes, for example Area under the NNC9204-0530 serum concentration-time curve, Maximum concentration of NNC9204-0530 in serum, The time to maximum concentration of NNC9204-0530 in serum and The terminal half-life of NNC9204-0530.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 163 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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