NCT07754474招募中1 期
A Phase I, Randomized, Single-blind, Parallel-group Trial for BI 3034701 Compared to Placebo in Participants With Overweight / Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 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
The main objectives of this trial are to investigate safety, tolerability of alternative dose titration strategies and pharmacokinetics (PK) of BI 3034701 in participants with overweight / obesity and at least one weight related co-morbidity following subcutaneous administration.
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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female trial participant, overweight/obese with one weight related complication but otherwise healthy according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 74 years (inclusive)
- •Body mass index (BMI) of 27.0 to 39.9 kg/m² (inclusive)
- •Signed and dated written informed consent in accordance with international council for harmonisation - good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
- •Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator, unless confirming the weight related complication
- •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 bpm, unless arterial hypertension is the weight related complication in the context of this trial
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance and may interfere with trial participation or interpretation of the results, other than abnormalities attributable to the permitted weight-related complications
- •Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m² (chronic kidney disease epidemiology collaboration (CKD-EPI)) at screening or trial participants requiring dialysis
- •Further exclusion criteria apply.
研究组 & 干预措施
Dose Group 1
Experimental
Low dose of BI 3034701.
干预措施: BI 3034701 (Drug)
Placebo
Placebo Comparator
Placebo to BI 3034701.
干预措施: Placebo (Drug)
Dose Group 2
Experimental
High dose of BI 3034701.
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: Up to 113 days
次要结局
- Area under the concentration-time curve of the analyte in plasma over the dosing interval of 0 to 168 hours (AUCτ) following multiple doses of BI 3034701(Up to 106 days)
- Maximum measured concentration of the analyte in plasma (Cmax) following multiple doses of BI 3034701(Up to 106 days)
研究者
研究点 (1)
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