NCT05996848已完成3 期
Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) Once-Weekly in Chinese Participants With Overweight or Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 65
- 主要终点
- CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
研究概览
简要总结
This study will look at how well the new medicine CagriSema helps people with excess body weight losing weight compared to a "dummy" medicine and a medicine called semaglutide. Participants will either get CagriSema, a dummy medicine or semaglutide. Which treatment participants get is decided by chance. Participants will take one injection once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for about 1 year.
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
- Double (Participant, Investigator)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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 kilograms per square meter (kg/m^2) or
- •BMI greater than or equal to 27.0 kg/m^2 with the presence of at least one weight-related comorbidity including, but not limited to, type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- •For participants with Type 2 diabetes (T2D) at screening the following criteria also apply:
- •Diagnosed with type 2 diabetes mellitus greater than equal to 180 days before screening
- •Treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i)), thiazolidinediones, or sulphonylureas (SUs) as a single agent or in combination) according to local label
- •Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 60 days before screening
- •Glycated Haemoglobin (HbA1c) 7 percent-10 percent (53-86 millimoles per mole [mmol/mol]) (both inclusive) as measured by the central laboratory at screening
排除标准
- •For participants without T2D at screening:
- •HbA1c greater than or equal to 6.5 percent (48 mmol/mol) as measured by the central laboratory at screening
- •History of type 1 or type 2 diabetes mellitus
- •For participants with T2D at screening:
- •Clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness
- •Renal impairment with estimated glomerular filtration rate (eGFR) lesser than 30 milli liter per min/1.73 meter square (mL/min/1.73 m^2), as measured by the central laboratory at screening
- •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
干预措施: Placebo Semaglutide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 44 weeks.
干预措施: Placebo Cagrilintide (Drug)
CagriSema
Experimental
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
干预措施: Cagrilintide (Drug)
CagriSema
Experimental
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 44 weeks.
干预措施: Semaglutide (Drug)
Semaglutide
Active Comparator
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
干预措施: Semaglutide (Drug)
Semaglutide
Active Comparator
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 44 weeks.
干预措施: Placebo Semaglutide (Drug)
结局指标
主要结局
CagriSema 2.4 mg/2.4 mg versus placebo: Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 44)
Measured in percentage (%)
CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 5%
时间窗: From baseline (week 0) to end of treatment (week 44)
Measured as count of participants
次要结局
- CagriSema 2.4 mg/2.4 mg versus placebo: Change in waist circumference(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 15%(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Change in waist circumference(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 20%(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Fasting Plasma Glucose (FPG)(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in fasting serum insulin(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Change in IWQOL-Lite-CT Total score(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg: Relative change in body weight(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Number of participants who achieve (yes/no): Body weight reduction greater than or equal to 10%(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Glycated Haemoglobin (HbA1c)(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Systolic Blood Pressure (SBP)(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Change in Diastolic Blood Pressure (DBP)(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in total cholesterol(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in triglycerides(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Relative change in free fatty acids(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Change in Short Form-36 Version 2.0 (SF- 36v2) Physical Functioning score(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Physical Component Summary Score(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Change in SF-36v2: Mental Component Summary score(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo: Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOLLite- CT) Physical Function score(From baseline (week 0) to end of treatment (week 44))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Serious Adverse Events (TESAEs)(From baseline (week 0) to end of study (week 51))
- Number of clinically significant hypoglycaemic episodes (level 2) (lesser than 3.0 mmol/L (54 milligrams per deciliter[mg/dL]), confirmed by BG meter) (only for participants with Type 2 diabetes (T2D) at screening)(From baseline (week 0) to end of study (week 51))
- CagriSema 2.4 mg/2.4 mg versus placebo and semaglutide 2.4 mg: Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to end of study (week 51))
- Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold (only for participants with T2D at screening)(From baseline (week 0) to end of study (week 51))
研究者
研究点 (65)
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