Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 809
- 试验地点
- 75
- 主要终点
- To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
研究概览
简要总结
This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year 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
- None
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 18 years or above at the time of signing the informed consent
- •Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)
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 mellitus
研究组 & 干预措施
CagriSema 2.4 mg/2.4 mg
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks.
干预措施: Cagrilintide (Drug)
CagriSema 2.4 mg/2.4 mg
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks.
干预措施: Semaglutide (Drug)
Tirzepatide 15 mg
Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.
干预措施: Tirzepatide (Drug)
结局指标
主要结局
To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 84)
Measured in percentage (%).
次要结局
- To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight(From baseline (week 0) to end of treatment (week 84))
- Achievement of greater than or equal to (≥) 25% weight reduction(From baseline (week 0) to end of treatment (week 84))
- Achievement of ≥ 30% weight reduction(From baseline (week 0) to end of treatment (week 84))
- Change in waist circumference(From baseline (week 0) to end of treatment (week 84))
- Change in systolic blood pressure (SBP)(From baseline (week 0) to end of treatment (week 84))
- Change in diastolic blood pressure (DBP)(From baseline (week 0) to end of treatment (week 84))
- Relative change in lipids: Total cholesterol(From baseline (week 0) to end of treatment (week 84))
- Relative change in lipids: High-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 84))
- Relative change in lipids: Non-HDL cholesterol(From baseline (week 0) to end of treatment (week 84))
- Relative change in lipids: Low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 84))
- Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 84))
- Relative change in lipids: Triglycerides(From baseline (week 0) to end of treatment (week 84))
- Number of Treatment-emergent Adverse Events (TEAEs)(From baseline (week 0) to end of study (week 90))
- Number of Treatment Emergent Serious adverse events (TESAEs)(From baseline (week 0) to end of study (week 90))