2023-506924-94-00招募中3 期
The cardiovascular safety and efficacy of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with established cardiovascular disease
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 2,011
- 试验地点
- 168
- 主要终点
- Time to first occurrence of MACE, a composite endpoint consisting of: • CV death • non-fatal myocardial infarction • non-fatal stroke
研究概览
简要总结
To confirm non-inferiority of CagriSema 2.4mg/2.4mg versus placebo with respect to time to first major adverse cardiovascular event (MACE)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •Age above or equal to 55 years at the time of signing informed consent
- •Body mass index (BMI) ≥ 25.0 kg/m2
- •Established CVD as evidenced by at least one of the following: • Prior myocardial infarction • Prior stroke (ischemic or haemorrhagic stroke) • Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: a. Intermittent claudication with an ankle-brachial index (ABI) < 0.85 at rest b. Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound c. Prior revascularization procedure of a lower extremity peripheral artery d. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
- •For participants with T2D at screening, the following inclusion criteria also apply: Diagnosed with type 2 diabetes mellitus (T2D) ≥ 180 days before screening. HbA1c 6.5%-10% (48-86 mmol/mol) (both inclusive), as measured by central laboratory at screening. Treatment with either: a. Lifestyle intervention alone b. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i), DPP4-inhibitors, thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local label c. Basal insulin alone or in combination with up to two marketed OADs (refer to b. above), all according to local label
排除标准
- •Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening
- •Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
- •Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before screening
- •End stage renal disease defined as eGFR < 15 mL/min/1.73 m2, as measured by the central laboratory at screening
- •Chronic or intermittent haemodialysis or peritoneal dialysis
研究组 & 干预措施
cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide, cagrilintide semaglutide
Test
干预措施: cagrilintide semaglutide (Drug)
Placebo + Placebo
Placebo
干预措施: Placebo + Placebo (Drug)
结局指标
主要结局
Time to first occurrence of MACE, a composite endpoint consisting of: • CV death • non-fatal myocardial infarction • non-fatal stroke
Time to first occurrence of MACE, a composite endpoint consisting of: • CV death • non-fatal myocardial infarction • non-fatal stroke
次要结局
- Ratio to baseline in IL-6
- Ratio to baseline in IL-1β
- Change in pain intensity rated by Numerical Rating Scale (NRS)
- Change in Pittsburgh Sleep Quality Index (PSQI)
- CCI
- Time to first occurrence of a composite endpoint consisting of: • Onset of persistent ≥40% reduction in eGFRcr (CKD EPI) compared with baseline • Onset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m2 • Initiation of chronic kidney replacement therapy (dialysis or kidney transplantation) • Kidney death • CV death
- Time to first occurrence of an expanded MACE composite endpoint consisting of: • CV death • non-fatal myocardial infarction • non-fatal stroke • coronary revascularisation • unstable angina requiring hospitalisation
- Ratio to baseline in TNF-α
- Time to first occurrence of a composite endpoint consisting of: • all-cause death • non-fatal myocardial infarction • non-fatal stroke
- Time to first occurrence of myocardial infarction (fatal and non fatal)
- Time to first occurrence of stroke (fatal and non fatal)
- Relative change in body weight
- Change in waist circumference
- Change in systolic blood pressure (SBP)
- Change in diastolic blood pressure (DBP)
- ratio to baseline in lipids: • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Free fatty acids
- Change in HbA1c
- Change in SF-36v2: • Physical Component Summary score • Mental Component Summary score
- Number of TESAEs
- Number of event adjudication committee (EAC)-confirmed malignant neoplasms
- Number of severe hypoglycaemic episodes (level 3) (only for participants with T2D at screening)
- Ratio to baseline in hsCRP
- Change in neuropathy status by baseline neuropathy group (painful neuropathy, painless neuropathy or no neuropathy)
- Time to first occurrence of a composite endpoint consisting of: • Onset of persistent macro albuminuria • Onset of persistent ≥40% reduction in eGFRcr (CKD EPI) compared with baseline • Onset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m2 • Initiation of chronic kidney replacement therapy (dialysis or kidney transplantation) • Kidney death
- Change in eGFRcr (CKD-EPI)
- Ratio to baseline in UACR
- Change in waist-to-height ratio
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (168)
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