Atherosclerotic cardiovascular disease MedDRA version: 26.0 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Product Name: Cagrilintide B 1.0 mg/ml + semaglutide I 0.5 mg/ml DV3384
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Cagrilintide
Other descriptive name: Cagrilin
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm non-inferiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first major adverse cardiovascular event (MACE).;Secondary Objective: - To confirm superiority of CagriSema 2.4 mg/2.4 mg versus placebo with respect to time to first MACE. - To compare the effect of CagriSema 2.4 mg/2.4 mg versus placebo on: a. CV outcomes b. CV risk factors c. Body weight d. Glucose metabolism e. SF-36v2 physical and mental components of health - To compare the safety and tolerability of CagriSema 2.4 mg/2.4 mg versus placebo - To compare the effect of CagriSema 2.4 mg/2.4 mg versus placebo on: a. Biomarkers linked to CV risk and inflammation b. Painful and painless peripheral neuropathy;Primary end point(s): 1. Time to first occurrence of MACE, a composite endpoint consisting of: CV death, non-fatal myocardial infarction, non-fatal stroke;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to end of study (up to 242 weeks or more) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Time to occurrence of CV death 2. Time to first occurrence of a composite heart failure endpoint consisting of: • CV death • heart failure hospitalisation • urgent heart failure visit 3.. Time to first occurrence of a composite endpoint consisting of: • Onset of persistent =40% reduction in eGFRcr (CKD EPI) compared with baseline, • Onset of persistent eGFRcr (CKD-EPI) <15 mL/min/1.73 m^2 • Initiation of chronic kidney replacement therapy (dialysis or kidney transplantation) • Kidney death • CV death 4. Time to occurrence of all-cause death 5. Time to first occurrence of an expanded MACE composite endpoint consisting of: • CV deathb,c • non-fatal myocardial infarction • non-fatal stroke • coronary revascularisation • unstable angina requiring hospitalisation 6. Time to first occurrence of a composite endpoint consisting of: • all-cause death • non-fatal myocardial infarction • non-fatal stroke 7. Time to first occurrence of myocardial infarction (fatal and non fatal) 8. Time to first occurrence of stroke (fatal and non fatal) 9. Relative change in body weight 10. Change in waist circumference 11. Change in systolic blood pressure (SBP) 12. Change in diastolic blood pressure (DBP) 13. Relative change in lipids: • Total cholesterol • HDL cholesterol • LDL cholesterol • VLDL cholesterol • Triglycerides • Free fatty acids 14. Change in HbA1c 15. Change in SF-36v2: • Physical Component Summary score • Mental Component Summary score 16. Number of TESAEs 17. Number of event adjudication committee (EAC)-confirmed malignant neoplasms 18. Number of severe hypoglycaemic episodes (level 3) (only for participants with T2D at screening) 19. hsCRP 20. TNF-a 21. IL-6 22. IL-1ß 23. Change in pain intensity rated by Numerical Rating Scale (NRS) 24. Change in Pittsburgh Sleep Quality Index (PSQI) 25. Change in neuropathy status by baseline neuropathy group (painful neuropathy, painless neuropathy or no neuropathy) ;Timepoint(s) of evaluation of this end poin | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, European Union, France, Germany, India, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Serbia, South Africa, Spain, Thailand, Türkiye, United Kingdom, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed