CTIS2023-506924-94-00进行中（未招募）1 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 - NN9838-4942
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,054
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
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, a-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
研究者
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