Effect of CagriSema, Semaglutide and Cagrilintide on Skeletal Muscle Insulin Sensitivity, Composition and Function
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
研究概览
简要总结
The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 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)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •Age 50-70 years (both inclusive) at the time of signing the informed consent.
- •Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening (V1).
- •Excess body weight should be due to excess adipose tissue, as judged by the investigator.
- •Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment.
排除标准
- •Any leg amputations.
- •Female participants who are not postmenopausal at screening.
- •Any clinically significant body weight change (greater than or equal to [>=] 5% self-reported change) or dieting attempts within 90 days before screening.
- •Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist or a medication with GLP-1 activity within 90 days before screening.
研究组 & 干预措施
Cagrilintide
Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks.
干预措施: Placebo cagrilintide (Drug)
Placebo
Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks.
干预措施: Placebo cagrilintide (Drug)
Placebo
Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide for up to 52 weeks.
干预措施: Placebo semaglutide (Drug)
Cagrilintide
Participants will receive once weekly s.c. dose of cagrilintide for up to 52 weeks.
干预措施: Cagrilintide (Drug)
CagriSema
Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks.
干预措施: Cagrilintide (Drug)
CagriSema
Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) for up to 52 weeks.
干预措施: Semaglutide (Drug)
Semaglutide
Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks.
干预措施: Semaglutide (Drug)
Semaglutide
Participants will receive once weekly s.c. dose of semaglutide for up to 52 weeks.
干预措施: Placebo semaglutide (Drug)
结局指标
主要结局
Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle
时间窗: Baseline to Week 51
Measured in micromoles per 100 grams per minute (μmol/100g/min).
次要结局
- Change in insulin-stimulated FDG uptake in skeletal muscle(Baseline to Week 20)
- Change in insulin-stimulated FDG uptake in skeletal muscle(Baseline to Week 51)