Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria -Part A:
A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Further inclusion criteria apply.
-Part B:
Further inclusion criteria apply.
Exclusion criteria -Part A:
Further exclusion criteria apply.
-Part B:
Further exclusion criteria apply.
Primary purpose
Allocation
Interventional model
Masking
82 participants in 7 patient groups
Loading...
Central trial contact
Boehringer Ingelheim
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal