Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 25
- 主要终点
- Relative change in body weight
研究概览
简要总结
This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age above or equal to 18 years at the time of signing informed consent
- •Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m^2) or
- •BMI ≥27.0 kg/m2 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
- •Glycated 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
研究组 & 干预措施
CagriSema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.
干预措施: Semaglutide (Drug)
CagriSema Dose 2
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
干预措施: Semaglutide (Drug)
CagriSema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.
干预措施: Cagrilintide (Drug)
CagriSema Dose 2
Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
干预措施: Cagrilintide (Drug)
Placebo Dose 1
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.
干预措施: Placebo (Drug)
Placebo Dose 2
Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.
干预措施: Placebo (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 68)
Measured in percentage (%).
Achievement of ≥5% weight reduction
时间窗: From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
次要结局
- Achievement of ≥10% weight reduction(From baseline (week 0) to end of treatment (week 68))
- Achievement of ≥15% weight reduction(From baseline (week 0) to end of treatment (week 68))
- Achievement of ≥20% weight reduction(From baseline (week 0) to end of treatment (week 68))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 68))
- Change in systolic blood pressure(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Total cholesterol(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Triglycerides(From baseline (week 0) to end of treatment (week 68))
- Ratio to baseline in lipids: Free fatty acids(From baseline (week 0) to end of treatment (week 68))
- Number of treatment emergent adverse events (TEAEs)(From baseline (week 0) to end of study (week 74))
- Number of treatment emergent serious adverse events (TESAEs)(From baseline (week 0) to end of study (week 74))