2022-502531-18-00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 and type 2 diabetes mellitus
Boehringer Ingelheim International GmbH, Boehringer Ingelheim RCV GmbH & Co. KG, Boehringer Ingelheim Espana S.A.49 个研究点 分布在 11 个国家目标入组 248 人开始时间: 2024年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 248
- 试验地点
- 49
- 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 the efficacy, safety, and tolerability of survodutide as an adjunct to a reduced-calorie diet and increased physical activity in comparison to placebo in participants with a BMI ≥27 kg/m^2 and 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（65+ Years, 18-64 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 ≥27 kg/m^2 at screening
- •Diagnosed with T2DM (defined as glycosylated haemoglobin A1c [HbA1c] ≥6.5% [≥48 mmol/mol]) at least 180 days prior to screening
- •HbA1c ≥6.5% (≥48 mmol/mol) and <10% (<86 mmol/mol) as measured by the central laboratory at screening
- •Currently treated for T2DM with either: diet and exercise alone or stable treatment (for at least 3 months prior to screening) with metformin, sodium-glucose cotransporter-2 inhibitor (SGLT2i), acarbose, sulfonylurea, or glitazone as single agent therapy, or up to 3 anti-hyperglycaemia medications (metformin, SGLT2i, acarbose, sulfonylurea, or glitazone) according to local label
- •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
- •Treatment with any medication for the indication obesity within 3 months before screening
- •Treatment with any medication for the indication of T2DM other than stated in the inclusion criteria within 3 months before the screening visit up to and including the randomisation visit (i.e. insulin, amylin analogues, GLP-1R agonists, GLP-1R agonist/insulin/GIP combinations, and dipeptidyl peptidase 4 inhibitor [DPP-4i])
- •QTc (Fridericia) mean interval greater than 500 ms at screening (triplicate electrocardiogram [ECG]) or personal or family history of long QT syndrome
- •Heart failure (HF) with NYHA 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 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)
- •Further exclusion criteria apply.
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 HbA1c (%) o Waist circumference (cm) o SBP (mmHg) o “Capacity to Resist” domain score of Eating Behaviour PRO (units on scale) o Eating Behaviour PRO total score (units on scael)
研究者
CT Disclosure & Data Transparency
Scientific
Boehringer Ingelheim International GmbH
研究点 (49)
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