A Study in Healthy Men to Test How BI 456906 is Processed in the Body

What Was Tested

This registered phase 1 trial tested Survodutide.

It had 1 arm (groups): BI 456906 (C-14) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 6 actual participants took part.

It was open to men only aged from 18 years up to 65 years.

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

Examples of who could join: Age of 18 to 65 years (inclusive). BMI of 23.0 to 34.9 kg/m2 (inclusive); body weight of at least 70 kg. Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: any finding in the medical examination (including bp, pr or ecg) deviating from normal and assessed as clinically relevant by the investigator; any laboratory value outside the reference range that the investigator considers to be of clinical relevance; any evidence of a concomitant disease assessed as clinically relevant by the investigator.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Survodutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-07-04 with completion listed for 2022-11-17.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 2 secondary outcomes, for example Maximum measured concentration of the analyte (Cmax) and Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable time point (AUC0-tz).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Survodutide in 6 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 Survodutide compound page, all human trials.