A Placebo-controlled Comparability Study to Compare Two Presentations of CagriSema in Participants With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 入组人数
- 1,400
- 试验地点
- 116
- 主要终点
- Relative change in body weight
研究概览
简要总结
This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.
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)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 (sex at birth)
- •Age 18 years or above at the time of signing the informing consent.
- •Body Mass Index (BMI) is greater than or equal to (>= ) 30.0 kilograms per square metre (kg/m^2) or BMI >= 27.0 kg/m^2 with the presence of at least one obesity-related complication including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
排除标准
- •Glycosylated haemoglobin (HbA1c) >= 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening.
- •History of type 1 or type 2 diabetes.
- •Previous exposure to CagriSema in a clinical study.
研究组 & 干预措施
CagriSema in device 1 + Placebo in device 2
Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
干预措施: Cagrisema (Drug)
CagriSema B in device 2 + Placebo in device 1
Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
干预措施: Cagrisema (Drug)
Placebo in device 1 + Placebo in device 2
Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.
干预措施: Placebo CagriSema (Drug)
结局指标
主要结局
Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%).
次要结局
- Number of TEAEs (treatment emergent adverse events)(From baseline (week 0) to end of study (week 51))
- Number of TESAEs (Treatment emergent serious adverse events)(From baseline (week 0) to end of study (week 51))