Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 234
- 试验地点
- 1
研究概览
简要总结
This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 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
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-64 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.
- •Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
研究组 & 干预措施
Cagrilintide B and Placebo Semaglutide I
Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks.
干预措施: Cagrilintide B and placebo semaglutide I (Drug)
Cagrilintide D-Injection site 3
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
干预措施: Cagrilintide D (Drug)
Cagrilintide D-Injection site 1
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
干预措施: Cagrilintide D (Drug)
Cagrilintide D-Injection site 2
Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.
干预措施: Cagrilintide D (Drug)