The Effect of Cagrilintide and Semaglutide Combination Treatment Compared to a Weight-loss Inducing Diet on Energy Metabolism in Persons Living With Obesity: an Open-label Randomised Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in sleeping metabolic rate (SMR)
研究概览
简要总结
In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female (sex assigned at birth).
- •Age 18-65 years (both inclusive) 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) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator.
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
- •History of diabetes mellitus of any type, other than gestational diabetes mellitus.
- •Claustrophobia or severe discomfort of being confined in small rooms.
- •Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.
- •Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
- •Treatment with metformin or other glucose-lowering agent(s) within 90 days before screening (V1), regardless of indication.
- •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening (Visit 1).
- •Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening (Visit 1).
- •Physical measurement exceeding the dimensions or load capacity of the magnetic resonance imaging (MRI)/dual-energy X-ray absorptiometry (DEXA) scanner.
研究组 & 干预措施
CagriSema (Cagrilintide + Semaglutide) / CagriSema
Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.
干预措施: CagriSema (Cagrilintide B + semaglutide I) (Drug)
Low Energy Diet (LED) / CagriSema
Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.
干预措施: CagriSema (Cagrilintide B + semaglutide I) (Drug)
Low Energy Diet (LED) / CagriSema
Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.
干预措施: Low Energy Diet (Behavioral)
结局指标
主要结局
Change in sleeping metabolic rate (SMR)
时间窗: Baseline (Week 0) to Week 20
Measured as kilojoules (kJ) per day.
次要结局
- Change in basal metabolic rate (BMR)(Baseline (Week 0) to Week 20)
- Change in 24-hour energy expenditure(Baseline (Week 0) to Week 20)
- Change in resting metabolic rate (RMR)(Baseline (Week 0) to Week 20)