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 number | NCT05296733 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Sponsor | Boehringer Ingelheim |
| Enrollment | 82 participants |
| Design | Interventional, Non Randomized, Parallel, Masking: None |
| Conditions | Healthy; Liver Diseases; Obesity |
| Interventions | BI 456906 |
| Start | Apr 27, 2022 |
| Primary completion | Dec 29, 2023 |
| Study completion | Dec 29, 2023 |
| Results posted | Not yet |
| Registry last updated | Aug 15, 2024 |
Compounds on this site that cite this trial
What the registry says the trial is about
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part.
This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906.
In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems.
In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems.
In both parts, doctors also 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 measure | Time frame |
|---|---|
| Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-u221e) | Up to 360 hours |
| Part A: Maximum measured concentration of BI 456906 in plasma (Cmax) | Up to 360 hours |
| Part B: Percentage of patients treated who experience treatment-emergent adverse event | Up to Day 218 |
1 secondary outcome 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.
