A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity

What Was Tested

The trial (phase 1) is built around Survodutide.

This study is open to adults between 18 and 55 years of age with overweight or obesity.

The purpose of this study is to find out whether a medicine called survodutide (BI 456906) has an effect on cardiac safety.

When a new medicine is developed, it is important to check whether it affects the heart.

It had three arms (groups): Arm A: R1 then R3 then T then R (experimental), Arm B: R1 then R2 then R1 then R3 (placebo comparator) and Arm C: R1 then R3 then R1 then R2 (placebo comparator).

Arm A: BI 456906-placebo (reference treatment 1 (R1)) then moxifloxacin-placebo (reference treatment 3 (R3)) then BI 456906 (Test Treatment (T)) then moxifloxacin-placebo (R3).

Arm B: BI 456906-placebo (R1) then moxifloxacin (Reference Treatment 2 (R2)) then BI 456906-placebo (R1) then moxifloxacin-placebo (R3).

Arm C: BI 456906-placebo (R1) then moxifloxacin-placebo (R3) then BI 456906-placebo (R1) then moxifloxacin (R2).

The registry classes the interventions as combination product and drug.

Who Took Part

110 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 27.0 to 39.9 kg/m2 (inclusive) and body weight \> 70 kg. Use of progestogen-only hormonal contraception that inhibits ovulation (oral, injectable or implantable). In case of oral contraception a barrier method should be used in addition. Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS). A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant.

The full record lists 12 inclusion and 14 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:; bilirubin above 1.2x uln (except for cases of gilbert's syndrome).

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Survodutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Survodutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-03-13 with completion listed for 2025-10-22.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Time-matched QTcI change from baseline (ΔQTcI) collected at the same time points as the BI 456906 plasma concentrations up to a maximum of 30 weeks after first drug administration of BI 456906 / BI 456906-placebo (time frame: up to 30 weeks).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Survodutide in 110 people.

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.