Safety and Tolerability of NN9068 in Healthy Male Volunteers

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe.

The aim of this clinical trial is to investigate the safety, tolerability, level of drug exposure and effect of NN9068.

The trial participants will be randomised to 4 different treatments in trial, receiving trial products in a pre-defined order.

It had four arms (groups): A (experimental), B (experimental), C (active comparator) and D (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male subjects, who are considered to be generally healthy, based on an assessment of medical history, physical examination, and clinical laboratory data, as judged by the Investigator. Body mass index (BMI) between 18.0 and 27.0 kg/m2 (both inclusive). Body weight between 60 kg and 90 kg (both inclusive).

The full record lists 3 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

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

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

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 2009-09 with completion listed for 2009-12.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number and severity of adverse events, number and severity of local tolerability issues at the injection site, number and severity of hypoglycaemic episodes (time frame: assessed 0-96 hours after trial product administration).

What This Means in Plain Language

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