A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
Completed · Phase 1
Conditions studied: Healthy, Liver Diseases, Obesity
In brief
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.
Key facts
- Study ID
- NCT05296733
- Run by
- Boehringer Ingelheim
- People needed
- 82
- Starts
- 2022-04-27
- Expected to finish
- 2023-12-29
- Last updated by the study team
- 2024-08-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- New Zealand Clinical Research (NZCR) — Auckland, New Zealand
- Dr. Piotr Napora, Center of Clinical Research — Wroclaw, Poland
- SUMMIT CLINICAL RESEARCH, s.r.o. — Bratislava, Slovakia
Full record on ClinicalTrials.gov
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