Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

What Was Tested

The trial (phase 1) is built around Semaglutide.

This trial is conducted in Europe.

It had four arms (groups): Oral 1 (experimental), Oral 2 (experimental), Oral 3 (experimental) and S.c. (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 96 actual participants took part.

It was open to men only aged from 18 years up to 60 years.

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

Examples of who could join: Healthy male subjects, based on an assessment of medical history, physical examination and. BMI between 21 and 30 kg/m2 (21 inclusive).

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: the receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

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.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2011-01 with completion listed for 2011-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Frequency of adverse events (AEs).

It also tracked 5 secondary outcomes, for example Hypoglycaemic episodes, Laboratory safety variables (haematology, biochemistry, and urinalysis), Maximum plasma concentration of NN9924 and Terminal phase elimination half-life.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 96 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.