A Phase I, Single-blinded, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Participants With Obesity/Overweight and Otherwise Healthy (Part 1) and Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 3034701 in Japanese Male and Female Healthy Volunteers (Part 2)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
Part 1:
To investigate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 3034701 in Japanese male and female participants with body mass index (BMI) ≥27.0 kg/m² or more following subcutaneous administration of multiple rising doses over 16 weeks.
Part 2:
To investigate safety, tolerability, and PK of BI 3034701 in Japanese male and female healthy participants with BMI ≥23.0 to <27.0 kg/m² following subcutaneous administration of multiple rising doses over 7 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese ethnicity, according to the following criteria: born in Japan, have lived outside of Japan < 10 years, and have parents and grandparents who are Japanese
- •Part 1: Male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
- •Part 2: Healthy male or female trial participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure, pulse rate), 12-lead electrocardiogram, and clinical laboratory tests
- •Parts 1 and 2: Age of 18 to 64 years (inclusive)
- •Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including blood pressure, pulse rate or electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and, in particular: alanine aminotransferase (ALT) above upper limit of normal (ULN) + 20%, aspartate aminotransferase (AST) above ULN + 20%, gamma-glutamyl transferase (GGT) above ULN + 20%, Lipase or amylase above ULN + 20%, bilirubin above 1.2x ULN (except for cases of Gilbert's Syndrome), estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73 m²
- •Part 1: Body weight increase or decrease (self-reported) of greater than 5% in the 3 months prior to screening
- •Further exclusion criteria apply.
研究组 & 干预措施
Placebo
Part 1: multiple rising doses in participants with BMI
≥27.0 kg/m² or more
Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m²
干预措施: Placebo (Drug)
BI 3034701
Part 1: multiple rising doses in participants with BMI
≥27.0 kg/m² or more
Part 2: multiple rising doses in participants with BMI ≥23.0 to <27.0 kg/m²
干预措施: BI 3034701 (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Part 1: up to Week 19, Part 2: up to Week 10
Expressed as the percentage of trial participants treated with investigational drug who experience such an event
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) following a single dose and multiple doses of BI 3034701(Part 1: up to Week 17, Part 2: up to Week 8)
- Maximum measured concentration of the analyte in plasma (Cmax) following a single dose and multiple doses of BI 3034701(Part 1: up to Week 19, Part 2: up to Week 10)
- Change from baseline in body weight at the end of 16 weeks treatment (only evaluated for Part 1)(Part 1: at Baseline and at Week 16)