The cardiovascular safety 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

Novo Nordisk India Private Limited55 个研究点分布在 1 个国家目标入组 4,000 人开始时间: 2023年9月28日最近更新: 2025年2月5日

试验速览

阶段: 3 期
状态: 已完成
发起方: Novo Nordisk India Private Limited
入组人数: 4,000
试验地点: 55
主要终点: Time to first occurrence of

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is an interventional 156-week, randomised, double-blind,placebo-controlled, two-armed, parallel-group, multicentre, multinationalclinical study primarily intended to assess the cardiovascular (CV) safety ofCagriSema 2.4 mg/2.4 mg versus placebo, both administered subcutaneously (s.c.)once-weekly and both added to standard of care in individuals with obesity andestablished cardiovascular disease (CVD). The study design will also allow forevaluation of neoplasm safety, due to the 3-year treatment duration.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围: 55.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•1.Informed consent obtained before any study-related activities.
•Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
•Male or female
•Age above or equal to 55 years at the time of signing informed consent
•Body mass index (BMI) â‰¥ 30.0 kg/m2
•Have established CVD as evidenced by at least one of the following: Prior myocardial infarction Prior stroke (ischemic or haemorrhagic stroke) 6.Symptomatic peripheral arterial disease (PAD) defined as at least one of the following: Intermittent claudication with an Ankle-brachial index (ABI) greater than 0.85 at rest, Intermittent claudication with a less than or equal to 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, MR angiography, CT angiography or Doppler ultrasound 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: 7.Diagnosed with type 2 diabetes mellitus â‰¥ 180 days before screening 8.HbA1c 7%-10% (53-86 mmol/mol) (both inclusive), as measured by central laboratory at screening.
•Treatment with either:Lifestyle intervention alone ,1-3 marketed oral antidiabetic drugs (OAD)s (metformin, Î±-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 Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening Basal insulin alone or in combination with up to two marketed OADs, all according to local label.

排除标准

•All exclusion criteria are based on declaration by the participant or the participantsâ€™ medical records, except for exclusion criteria #8 (diabetic retinopathy or maculopathy) and #18 (eGFR) which is assessed at the screening visit.
•Participants are excluded from the study if any of the following criteria apply: Cardiovascular related:
•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 Glycaemia related:
•Severe hypoglycaemia, as defined in Appendix 7 (Section 10.7), within 6 months before screening
•History of hypoglycaemia unawareness as indicated by the Investigator according to Clarkeâ€™s questionnaire question 8
•History of type 1 diabetes mellitus
•Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 90 days before 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 Obesity related:
•History of major depressive disorder within 2 years before screening
•Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
•A lifetime history of a suicidal attempt
•Suicidal behaviour within 30 days before screening General safety:
•History or presence of chronic pancreatitis
•Presence of acute pancreatitis within the past 180 days before screening
•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
•Presence or history of malignant neoplasms (other than basal and squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within 5 years before screening
•Chronic or intermittent haemodialysis or peritoneal dialysis
•Known or suspected abuse of alcohol or recreational drugs
•Known or suspected hypersensitivity to IMP(s) or related products
•Previous participation in this study.
•Participation is defined as randomisation
•Participation (i.e., signed informed consent) in any interventional, clinical study of an approved or non-approved investigational medicinal product within 90 days before screening
•Other participant(s) from the same household participating in any CagriSema study
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method as defined in Appendix 4 (Section 10.4)
•Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigatorâ€™s opinion, might jeopardise the participantâ€™s safety or compliance with the protocol.