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

This is a registry record, not a result. A trial being listed, recruiting or completed says nothing by itself about whether the compound works or is safe.

Registry numberNCT06352411
StatusCompleted
PhasePhase 1
SponsorBoehringer Ingelheim
Enrollment42 participants
DesignInterventional, Non Randomized, Parallel, Masking: None
ConditionsHealthy; Renal Impairment
InterventionsBI 456906
StartMay 15, 2024
Primary completionSep 16, 2025
Study completionSep 16, 2025
Results postedNot yet
Registry last updatedMar 13, 2026

Compounds on this site that cite this trial

What the registry says the trial is about

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. BI 456906 is being developed to treat people with obesity and liver problems. People living with these conditions often also have kidney problems. Therefore, it is important to find out whether kidney problems influence the amount of BI 456906 that gets into the blood.

Study participants receive a single dose of BI 456906 as an injection under the skin. Participants are divided into 4 groups based on how well their kidneys work: 1 group without kidney problems, and 3 groups with mild, moderate, and severe kidney problems. Each participant without kidney problems is matched with participants from the other groups based on factors such as age, gender, race, and body mass index (BMI) to ensure accurate comparisons.

Participants are in the study for about 2 months. They stay for 5 days and 4 nights at the study site and visit their doctors about 7 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The participants also answer questions about their well-being. The doctors regularly check participants' health and take note of any unwanted effects.

Primary outcomes

These are what the trial was designed to measure first. They are registered in advance, which is what makes a later result checkable.

Outcome measureTime frame
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)up to Day 29
Maximum measured concentration of BI 456906 in plasma (Cmax)up to Day 29

2 secondary outcomes also registered. See the registry record for the full list.

Source: ClinicalTrials.gov (U.S. National Library of Medicine). Last checked against the registry on Oct 3, 2026. See the trial changes feed for what has changed recently.