CTRI/2023/07/055739尚未招募3 期
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 - REDEFINE3
ovo Nordisk India Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
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
- •2. Male or female
- •3. Age above or equal to 55 years at the time of signing informed consent
- •4. Body mass index (BMI) = 30.0 kg/m2
- •5. 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 = 180 days before screening
- •8.HbA1c 7%-10% (53-86 mmol/mol) (both inclusive), as measured by central laboratory at screening.
- •9. Treatment with either:Lifestyle intervention alone ,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 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 participants’ 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:
- •1. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic
- •attack within 60 days before screening
- •2. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- •3. Heart failure classified as being in New York Heart Association (NYHA) Class IV at screening
- •Glycaemia related:
- •4. Severe hypoglycaemia, as defined in Appendix 7 (Section 10.7), within 6 months before
- •5. History of hypoglycaemia unawareness as indicated by the Investigator according to Clarke’s
- •questionnaire question 8
- •6. History of type 1 diabetes mellitus
- •7. Treatment with any medication for the indication of diabetes other than stated in the inclusion
- •criteria within 90 days before screening
- •8. 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:
- •9. Treatment with any GLP-1 RA or a medication with GLP-1 activity within 90 days before
- •Mental health related:
- •10. History of major depressive disorder within 2 years before screening
- •11. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
- •12. A lifetime history of a suicidal attempt
- •13. Suicidal behaviour within 30 days before screening
- •General safety:
- •14. History or presence of chronic pancreatitis
- •15. Presence of acute pancreatitis within the past 180 days before screening
- •16. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary
- •thyroid carcinoma
- •17. 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
- •18. End stage renal disease defined as eGFR < 15 mL/min/1.73 m2, as measured by the central
- •laboratory at screening48
- •19. Chronic or intermittent haemodialysis or peritoneal dialysis
- •20. Known or suspected abuse of alcohol or recreational drugs
- •21. Known or suspected hypersensitivity to IMP(s) or related products
- •22. Previous participation in this study. Participation is defined as randomisation
- •23. 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
- •24. Other participant(s) from the same household participating in any CagriSema study
- •25. 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)
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