A research study to see the effects of CagriSema on heart disease in people living with diseases in the heart and blood vessels

Phase 3

• Conditions: Health Condition 1: E669- Obesity, unspecified

• Registration Number: CTRI/2023/07/055739
• Lead Sponsor: ovo Nordisk India Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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, 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

Exclusion Criteria

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

screening

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

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 < 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)

26. Any

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first occurrence of <br/ ><br>MACE, a composite <br/ ><br>endpoint consisting of: <br/ ><br>? CV death, <br/ ><br>? non-fatal myocardial <br/ ><br>infarction, <br/ ><br>non-fatal strokeTimepoint: Time frame:From baseline (week 0) to end of study (up to 163 weeks or more). <br/ ><br>Unit: Month(s)