A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

What Was Tested

This registered phase 1 trial tested Survodutide.

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 20 to 40 kg/m2.

People with or without kidney problems can take part in the study.

The purpose of this study is to find out how much of a medicine called BI 456906 gets into the blood of people with and without kidney problems.

It had four arms (groups): Group 1: Participants with normal renal function (experimental), Group 2: Participants with mild renal impairment (experimental), Group 3: Participants with moderate renal impairment (experimental) and Group 4: Participants with severe renal impairment (experimental).

The registry classes the interventions as combination product.

Who Took Part

42 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

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

Examples of who could join: Male or female participants with age 18 to 80 years, inclusive at the screening visit. Body mass index (BMI) of 20.0-40.0 kg/m\^2 (inclusive). Male participants are not required to use contraception. Further criteria apply.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: any evidence of a concomitant disease assessed as clinically relevant by the investigator; history of relevant orthostatic hypotension, fainting spells, or blackouts; relevant chronic or acute infections further criteria apply.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

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

Everyone knew when Survodutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-05-15 with completion listed for 2025-09-16.

It ran at 2 sites in Germany (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) (time frame: up to Day 29). Maximum measured concentration of BI 456906 in plasma (Cmax) (time frame: up to Day 29).

It also tracked 2 secondary outcomes, for example Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) and Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Survodutide in 42 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.