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
- Registration Number
- NCT05296733
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 82
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: BI456906: Cohort 3 BI 456906 Patients with overweight/obesity with cirrhosis + CTP Class B Part A: BI 456906: Cohort 2 BI 456906 Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A Part B: BI456906: Cohort 2 BI 456906 Patients with overweight/obesity with cirrhosis + CTP Class A Part B: BI456906: Cohort 1 BI 456906 Patients with overweight/obesity without cirrhosis/hepatic impairment Part A: BI 456906: Cohort 1 BI 456906 Healthy subjects Part A: BI 456906: Cohort 3 BI 456906 Patients with cirrhosis + CTP Class B Part A: BI 456906: Cohort 4 BI 456906 Patients with cirrhosis + CTP Class C
- Primary Outcome Measures
Name Time Method Part B: Percentage of patients treated who experience treatment-emergent adverse event Up to Day 218 Part A: Maximum measured concentration of BI 456906 in plasma (Cmax) Up to 360 hours Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) Up to 360 hours
- Secondary Outcome Measures
Name Time Method Part A: Percentage of patients treated who experience treatment-emergent adverse event Up to Day 35
Trial Locations
- Locations (12)
SUMMIT CLINICAL RESEARCH, s.r.o.
🇸🇰Bratislava, Slovakia
Arizona Liver Health
🇺🇸Chandler, Arizona, United States
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Semmelweis University
🇭🇺Budapest, Hungary
Dr. Piotr Napora, Center of Clinical Research
🇵🇱Wroclaw, Poland
New Zealand Clinical Research (NZCR)
🇳🇿Auckland, New Zealand
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Covenant Metabolic Specialists, LLC
🇺🇸Sarasota, Florida, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, Texas, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
CRU Hungary Ltd.
🇭🇺Kistarcsa, Hungary