A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 12
- 主要终点
- Part B: Percentage of patients treated who experience treatment-emergent adverse event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part B: BI456906: Cohort 3
Patients with overweight/obesity with cirrhosis + CTP Class B
干预措施: BI 456906 (Drug)
Part B: BI456906: Cohort 2
Patients with overweight/obesity with cirrhosis + CTP Class A
干预措施: BI 456906 (Drug)
Part A: BI 456906: Cohort 1
Healthy subjects
干预措施: BI 456906 (Drug)
Part A: BI 456906: Cohort 2
Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A
干预措施: BI 456906 (Drug)
Part A: BI 456906: Cohort 3
Patients with cirrhosis + CTP Class B
干预措施: BI 456906 (Drug)
Part A: BI 456906: Cohort 4
Patients with cirrhosis + CTP Class C
干预措施: BI 456906 (Drug)
Part B: BI456906: Cohort 1
Patients with overweight/obesity without cirrhosis/hepatic impairment
干预措施: BI 456906 (Drug)
结局指标
主要结局
Part B: Percentage of patients treated who experience treatment-emergent adverse event
时间窗: Up to Day 218
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
时间窗: 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-∞)
时间窗: Up to 360 hours
次要结局
- Part A: Percentage of patients treated who experience treatment-emergent adverse event(Up to Day 35)
