A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 285
- 试验地点
- 72
- 主要终点
- Relative change in body weight
研究概览
简要总结
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
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
- •Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •Male or female (sex assigned at birth, inclusive of all gender identities).
- •Age 18 years or above at the time of signing the informed consent.
- •Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m^2), or BMI >= 27.0 kg/m^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
排除标准
- •History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D).
- •Previous dosing of marketed or non-marketed amylin-based compounds.
- •Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
研究组 & 干预措施
Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2
Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.
干预措施: Cagrilintide (Drug)
Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2
Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.
干预措施: Placebo cagrilintide (Drug)
Cagrilintide + placebo semaglutide in device 1 and placebo cagrilintide in device 2
Participants will receive cagrilintide along with placebo matched to semaglutide in device 1 and placebo matched to cagrilintide in device 2 subcutaneously (s.c) once weekly for 26 weeks.
干预措施: Placebo semaglutide (Drug)
Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
干预措施: Cagrilintide (Drug)
Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
干预措施: Placebo cagrilintide (Drug)
Cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
Participants will receive cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
干预措施: Placebo semaglutide (Drug)
Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
干预措施: Placebo cagrilintide (Drug)
Placebo cagrilintide in device 2 and placebo cagrilintide + placebo semaglutide in device 1
Participants will receive placebo matched to cagrilintide in device 2 and placebo matched to cagrilintide along with placebo matched to semaglutide in device 1 s.c once weekly for 26 weeks.
干预措施: Placebo semaglutide (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 26)
Measured as percentage (%).
次要结局
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to end of study (week 33))
- Number of Treatment Emergent Serious Adverse Events (TESAEs)(From baseline (week 0) to end of study (week 33))