A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity

What Was Tested

The trial (phase 1) is built around Survodutide.

The main objective of this trial is to establish the bioequivalence of survodutide in a pre-filled syringe (reference product \[formulation A\]) and in a vial (test product \[formulation B2\]) in male and female trial participants who are healthy or otherwise healthy with overweight/obesity, following subcutaneous administration.

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

Subcutaneous administration of formulation A (Reference) then formulation B2 (Test).

Subcutaneous administration of formulation B2 (Test) then formulation A (Reference).

The registry classes the interventions as combination product and drug.

Who Took Part

44 planned participants were the target.

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 22.0 to 39.9 kg/m\^2 (inclusive). 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. Further inclusion criteria apply.

The full record lists 5 inclusion and 5 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

It was run as a randomized, crossover and open-label study.

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

Each person switched between Survodutide and the comparison at some point, usually with a gap in between.

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

It started in 2026-09-02 with completion listed for 2026-12-08.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: Up to Day 22). Maximum measured concentration of the analyte in plasma (Cmax) (time frame: Up to Day 22). Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) (time frame: Up to Day 22).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 44 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Survodutide compound page, all human trials.