A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body

What Was Tested

This registered phase 1 trial tested Survodutide.

The main objective of this trial is to investigate relative bioavailability of BI 456906 reference formulation (Formulation A) vs.

BI 456906 test formulation (Formulation B2).

It had two arms (groups): BI 456906 formulation A then BI 456906 formulation B2 (experimental) and BI 456906 formulation B2 then BI 456906 formulation A (experimental).

BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment.

BI 456906 formulation A = Reference treatment BI 456906 formulation B2 = Test treatment.

The registry classes the interventions as combination product and drug.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Age of 18 to 55 years (inclusive). Body Mass Index (BMI) of 18.5 to 29.9 kg/m (inclusive). Signed and dated written informed consent in accordance with ICH-GCP (Harmonized Guideline for Good Clinical Practice) and local legislation prior to admission to the trial Further inclusion criteria apply.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: any finding in the medical examination (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 and, in particular:; bilirubin above 1.2x upper limit of normal (uln) (except for cases of gilbert's syndrome).

How the Study Was Run

Design: randomized, crossover and open-label.

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

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

Nothing was hidden in this open-label Survodutide study: the participants and staff both knew the treatment.

It started in 2025-07-28 with completion listed for 2025-10-07.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) (time frame: Up to 22 days). Cmax (maximum measured concentration of the analyte in plasma) (time frame: Up to 22 days).

It also tracked 1 secondary outcome, for example AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 16 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.