Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Cagrilintide and Semaglutide: Participants will be treated with CagriSema 2.4 mg by 2.4 mg s.c. or placebo s.c. administered once weekly, both on top of standard of care. For 156-week
C
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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, α-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
Exclusion criteria
Exclusion criteria: 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: 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 screening 5. History of hypoglycaemia unawareness as indicated by the Investigator according to Clarkeâ??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 screening 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 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) 26.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of MACE, a composite endpoint consisting of: ï?· CV death, ï?· non-fatal myocardial infarction, non-fatal strokeTimepoint: Time frame:From baseline (week 0) to end of study (up to 163 weeks or more). Unit: Month(s) | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to first occurrence of MACE, a composite endpoint consisting of: ï?· CV death ï?· non-fatal myocardial infarction, ï?· non-fatal strokeTimepoint: Time frame:From baseline (week 0) to end of study (up to 163 weeks or more). Unit: Month(s);Time to first occurrence of an expanded MACE composite endpoint consisting of: CV death non-fatal myocardial infarction, non-fatal stroke coronary revascularisation unstable angina requiring hospitalisationTimepoint: Time Frame: From baseline (week 0) to end of study (up to 163 weeks or more). Unit: Month(s);Time to first occurrence of a composite heart failure endpoint consisting of: CV death heart failure hospitalisation urgent heart failure visitTimepoint: Time Frame : From baseline (week 0) to end of study (up to 163 weeks or more). Unit : Month(s);Time to first occurrence of a composite endpoint consisting of: all-cause death non-fatal myocardial infarction non-fatal strokeTimepoint: Time Frame: From baseline (week 0) to end of study(up to 163 weeks or more);Time to occurrence of CV deathTimepoint: Time Frame: From baseline (week 0) to end of study (up to 163 weeks or more). Unit: Month(s) ;Time to first occurrence of non-fatal strokeTimepoint: Time frame:From baseline (week 0) to end of study (up to 163 weeks or more). Unit: Month(s);Relative change in body weightTimepoint: Time frame:From baseline (week 0) to end of treatment(week 156). Unit: percentage;Change in waist circumferenceTimepoint: Time frame:From baseline (week 0) to end of treatment(week 156). Unit:cm;Change in systolic blood pressure(SBP)Timepoint: Time frame:From baseline (week 0) to end of treatment(week 156). Unit: mmHg;Change in diastolic blood pressure(DBP)Timepoint: Time frame:From baseline (week 0) to end of treatment(week 156). Unit:mmHg;Relative change in lipids:ï?·Total cholesterolï?·HDL cholesterolï?·LDL cholesterolï?·VLDL cholesterolï?·Triglyceridesï?·Free fatty acidsTimepoint: Time frame:From baseline ( | — |
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, France, Germany, India, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Serbia, South Africa, Spain, Turkey, United Kingdom, United States of America
Contacts
Public ContactVijay Parthasarathy
Novo Nordisk India Private Limited
Outcome results
None listed