Trial · Interventional
CompletedPhase 1Registry dataA Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 42 participants (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Design
- Not randomized · Open label (no masking)
- Countries
1 country
Germany
- Start
- 15 May 2024
- Primary completion
- 16 Sept 2025
- Completion
- 16 Sept 2025
- First posted
- 8 Apr 2024
- Last update posted
- 13 Mar 2026
- Conditions
- Healthy · Renal Impairment
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
NCT0635241115 May 2024 to 16 Sept 2025
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- BI 456906Combination product
Arms4
Experimental
Group 1: Participants with normal renal function
Experimental
Group 2: Participants with mild renal impairment
Experimental
Group 3: Participants with moderate renal impairment
Experimental
Group 4: Participants with severe renal impairment
Primary outcomes2
Outcomes the sponsor listed as primary.
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
Secondary outcomes(2)
Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame · up to Day 29
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
Time frame · up to 36 days
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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