A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity

What Was Tested

In this phase 1 trial, researchers set out to test Survodutide.

This study is open to adults with overweight or obesity who are otherwise healthy.

People can join the study if they have a body mass index of 27 to 39.9 kg/m2 and a body weight over 70 kg.

It had 1 arm (groups): All participants (experimental).

In Period 1: Bupropion, Caffeine, Midazolam are given as a reference treatment. In Period 2: Survodutide, Bupropion, Caffeine, Midazolam are given as a test treatment.

The registry classes the interventions as combination product and drug.

Who Took Part

34 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Age of 18 to 60 years (inclusive) at signing of informed consent. Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive) and body weight \> 70 kg. Further inclusion criteria apply.

The full record lists 5 inclusion and 10 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 and in particular:; 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 2024-10-01 with completion listed for 2025-12-16.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Area under the concentration-time curve of bupropion in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) (time frame: Up to week 32). Area under the concentration-time curve of the caffeine in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) (time frame: Up to week 32). Area under the concentration-time curve of midazolam in plasma over the time interval from 0 extrapolated to infinity (AUC 0-∞) (time frame: Up to week 32).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Survodutide in 34 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.