IRB Study Number 23-102
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Endocrinology and Metabolism Institute
Description
The primary objective is to confirm the CV safety of CagriSema 2.4 mg/2.4 mg versus placebo, both added to the standard of care in participants with obesity, established CVD, with or without type 2 diabetes mellitus (T2D) and with or without chronic kidney disease (CKD), regardless of adherence to treatment and changes to background intervention.
The study consists of a screening period to assess the participant’s eligibility, a 156-week treatment period (consisting of a 16-week dose escalation period and a 140-week maintenance period) and a 7-week follow-up period. The total study duration for each participant will be approximately 166 weeks (up to 3 weeks screening, 156 weeks treatment and 7 weeks follow-up).
Inclusion Criteria
- Male or female
- Age above or equal to 55 years at the time of signing informed consent.
- Body mass index (BMI) ≥ 30.0 kg/m2
- Established CVD as evidenced by at least one of the following: Prior myocardial infarction, Prior stroke (ischemic or haemorrhagic stroke), pymptomatic peripheral arterial disease (PAD), Prior revascularization procedure of a lower extremity peripheral artery, Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
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
- 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 < 15 mL/min/1.73 m2 , as measured by the central laboratory at screening
- Chronic or intermittent haemodialysis or peritoneal dialysis
