NL-OMON55925招募中3 期
The cardiovascular safety of efficacy 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 established cardiovascular disease - Redefine 3
ovo Nordisk0 个研究点目标入组 160 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
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 64（—）
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/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
- •a. Intermittent claudication with an Ankle-brachial index (ABI) below 0.85 at
- •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
- •- 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 (OAD)s (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 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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