2022-502529-17-00招募中3 期
A Phase 3, randomised, double-blind, parallel-group, 76-week, efficacy and safety study of BI 456906 administered subcutaneously compared with placebo in participants with overweight or obesity without type 2 diabetes
Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG29 个研究点 分布在 6 个国家目标入组 130 人开始时间: 2024年1月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 29
- 主要终点
- Percentage change in body weight from baseline to Week 76
研究概览
简要总结
This trial aims to investigate efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in trial participants with a BMI ≥30 kg/m^2 or a BMI ≥27 kg/m^2 with at least one weight-related complication but without T2DM. Primary objective is to demonstrate superiority of survodutide low and high dose against placebo.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up 2 period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- •BMI ≥30 kg/m² at screening, OR BMI ≥27 kg/m² with the presence of at least one of the following weight-related complications (treated or untreated): - Hypertension (defined as repeated, i.e. at least 3 measurements in resting condition, SBP values of ≥140 mmHg and/or DBP values of ≥90 mmHg in the absence of anti-hypertensive treatment, or intake of at least 1 anti-hypertensive drug to maintain a normotensive blood pressure) - Dyslipidaemia (defined as at least 1 lipid-lowering treatment required to maintain normal blood lipid levels, or LDL cholesterol ≥160 mg/dL (≥4.1 mmol/L), or triglycerides ≥150 mg/dL (≥1.7 mmol/L), or HDL cholesterol <40 mg/dL (<1.0 mmol/L) for men or HDL cholesterol <50 mg/dL (<1.3 mmol/L) for women) - Obstructive sleep apnoea - CVD (e.g. HF with NYHA functional class II-III, history of ischaemic or haemorrhagic stroke or cerebrovascular revascularisation procedure [e.g. carotid endarterectomy and/or stent], MI, coronary artery disease, or peripheral vascular disease) - NASH, as assessed in medical records by histological liver assessment (within the last 6 months)
- •History of at least one self-reported unsuccessful dietary effort to lose body weight
- •Further inclusion criteria apply.
排除标准
- •Body weight change (self-reported) of >5% within 3 months before screening
- •Trial participants who demonstrate recent evidence (within 3 months prior to screening) of acute or unstable cardiovascular events, e.g. hospitalisation for HF, acute coronary syndrome, unstable angina, MI, ischaemic or haemorrhagic stroke, transient ischaemic attack, and/or acute peripheral vascular event
- •Further exclusion criteria apply.
- •Treatment with any medication for the indication obesity within 3 months before screening
- •HbA1c ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
- •History of T1DM or T2DM or treatment with glucose lowering agent started within 3 months before the screening visit up to and including the randomisation visit
- •QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- •HF with NYHA functional class IV
- •Known clinically significant gastric emptying abnormality (e.g. severe diabetic gastroparesis or gastric outlet obstruction)
- •History of either chronic or acute pancreatitis or elevation of serum lipase or serum pancreatic amylase >2x upper limit of normal (ULN) as measured by the central laboratory at screening
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
结局指标
主要结局
Percentage change in body weight from baseline to Week 76
Percentage change in body weight from baseline to Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
次要结局
- Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76
- Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76
- Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76
- Absolute change from baseline to Week 76 in: o Body weight (kg) o Waist circumference (cm) o Systolic blood pressure (SBP) (mmHg) o “Capacity to Resist” domain score of the Eating Behaviour PRO (units on scale) o Eating Behaviour PRO total score (units on scale)
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (29)
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