EUCTR2021-005855-35-DE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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 7,000
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
- 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) above or equal 25.0 kg/m^2
- •- 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) below 0.85 at rest
- •b. Intermittent claudication with a above or equal 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) above or equal to 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 3000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4000
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 below 15 mL/min/1.73 m^2, as measured by the central laboratory at screening
- •- Chronic or intermittent haemodialysis or peritoneal dialysis
研究者
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