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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
BI 456906
Arizona Liver Health
Chandler, Arizona, United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, United States
Covenant Metabolic Specialists, LLC
Sarasota, Florida, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
Universitätsklinikum Bonn AöR
Bonn, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Ulm
Ulm, Germany
Semmelweis University
Budapest, Hungary
CRU Hungary Ltd.
Kistarcsa, Hungary
...and 3 more locations
Part A: 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 360 hours
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
Time frame: Up to 360 hours
Part B: Percentage of patients treated who experience treatment-emergent adverse event
Time frame: Up to Day 218
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Time frame: Up to Day 35
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