Cardiovascular Study in Adults 50+ With Cardiovascular or Kidney Disease

About the Study

Cardiovascular disease (CVD) is the leading cause of illness and death worldwide, with millions of people experiencing heart attacks, strokes, and other serious cardiovascular complications each year. Chronic kidney disease (CKD) also increases the risk of these events.

This study is investigating whether a once-daily oral tablet can reduce the risk of major cardiovascular events such as heart attack, stroke, hospitalisation for heart failure, coronary procedures, or death in people who already have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). The study will also assess how the investigational medicine affects kidney health and overall safety over time.

Who is it for?

Participants may be eligible if they meet the criteria below:

• You are aged 50 years or older
• Have established atherosclerotic cardiovascular disease or chronic kidney disease
• Have at least one of the following:
• History of heart attack or prior coronary procedure (stent/bypass)
• Previous ischemic stroke or carotid artery disease/procedure
• Peripheral artery disease with prior diagnosis, revascularization, or amputation
• Chronic kidney disease based on kidney function and urine protein levels
• If you have not had any type of cancer in the last 5 years. However, these mild or early cancers are okay and do not exclude you: Basal cell or squamous cell skin cancers (common, low-risk skin cancers), cervical cancer that was found very early and hasn’t spread, very early or low-grade prostate cancer
• You are using contraception (if applicable)
• You are willing to commit to an approx. 3.3-year study

What does participation look like?

If you are eligible, you will be in the study for approximately 3.3 years. During this time, you will attend approximately 16 clinic visits and complete 4 phone calls with the study team. In the beginning, you will visit the clinic every 4 weeks, and after the early visits are complete, you will return every 24 weeks for long-term follow-up.

At these visits, the study team will collect your medical history, carry out physical examinations (including waist and hip measurements), check your vital signs, record your heart activity with an ECG, and perform blood tests. Some of these visits will require you to be fasting, so you would need to be available in the mornings

You will be randomly assigned to receive either the investigational medicine or a placebo tablet once daily, in addition to your usual medications for heart or kidney health. Neither you nor the study team will know which tablet you are receiving, as this is a double-blind study designed to ensure unbiased results. Treatment will begin with a low dose and gradually increase until you reach a maintenance dose you are comfortable with. If you experience side effects, such as gastrointestinal discomfort, your dose may be adjusted to a level you can tolerate.

The time commitment for each visit may vary. Early visits, including screening and dose-escalation appointments, may take several hours, while later follow-up visits may take between 30 and 60 minutes. Visits will need to be done during our clinic business hours of 9am-5pm, Monday-Friday.

There will be a reimbursement provided to eligible participants.