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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 755
- 试验地点
- 264
- 主要终点
- Percentage change in body weight from baseline to Week 76
研究概览
简要总结
This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate.
The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight.
Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff.
The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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.
- •Body mass index (BMI) ≥27 kg/m^2 at screening.
- •Diagnosed with Type 2 diabetes mellitus (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) per treatment guidelines.
- •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 indication of T2DM other than stated in the inclusion criteria and glucagon-like peptide-1 receptor (GLP-1R)-based agonists) and dipeptidyl peptidase 4 inhibitor [DPP-4il).
- •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 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).
- •Further exclusion criteria apply.
研究组 & 干预措施
Placebo
干预措施: Placebo (Combination Product)
Survodutide 3.6 mg
干预措施: Survodutide (Combination Product)
Survodutide 6.0 mg
干预措施: Survodutide (Combination Product)
结局指标
主要结局
Percentage change in body weight from baseline to Week 76
时间窗: Baseline and at Week 76
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 76
时间窗: Baseline and at Week 76
次要结局
- Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 76(Baseline and at Week 76)
- Achievement of body weight reduction ≥15% (yes/no) from baseline to Week 76(Baseline and at Week 76)
- Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 76(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in body weight (kg)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in glycosylated haemoglobin A1c (HbA1c) (%)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in waist circumference (cm)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in systolic blood pressure (SBP) (mmHg)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in "Capacity to Resist" domain score of Eating Behaviour patient reported outcome (PRO)(Baseline and at Week 76)
- Key secondary endpoint: Absolute change from baseline to Week 76 in Eating Behaviour PRO total score(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in body mass index (BMI) (kg/m2)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in HbA1c (mmol/mol)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in diastolic blood pressure (DBP) (mmHg)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in fasting plasma glucose (FPG) (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in fasting plasma insulin (FPI) (mIU/L)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in total cholesterol (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in high density lipoprotein (HDL) cholesterol (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in low density lipoprotein (LDL) cholesterol (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in very-low-density lipoprotein (VLDL) cholesterol (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in triglycerides (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in free fatty acids (mg/dL)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in alanine aminotransferase (ALT) (U/L)(Baseline and at Week 76)
- Absolute change from baseline to Week 76 in aspartate aminotransferase (AST) (U/L)(Baseline and at Week 76)