Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

What Was Tested

The trial (phase 1) is built around Survodutide.

It had two arms (groups): BI 456906 (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 20 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Age of 18 to 45 years (incl.). Body Mass Index (BMI) of 20.0 to 29.9 kg/m2 (incl.). Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and local legislation.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: any laboratory value outside the reference range that the investigator considers to be of clinical relevance; gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders; diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders.

How the Study Was Run

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

The participants were allocated by chance, so the Survodutide group and the comparison group should start out alike.

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

Only one side, usually the participants, was kept unaware of whether Survodutide was given.

Those kept unaware of assignments: participant.

It started in 2017-06-30 with completion listed for 2018-02-19.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): [N (%)] of subjects with drug-related adverse events (time frame: Up to 672 hours).

It also tracked 2 secondary outcomes, for example AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h) and Cmax (maximum measured concentration of the analyte in plasma).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 20 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.