Unfortunately, if any of the following apply to you, this study is not the right fit for you:

• Myocardial infarction (heart attack), stroke, hospitalisation for unstable angina pectoris (chest pain) or transient ischaemic attack within 60 days before screening. 
• Scheduled procedures, known on the day of screening, aimed at improving blood flow in the arteries of the heart, neck, or limbs. Examples include stenting and bypass grafting. 
• Severe heart failure. 
• End stage renal disease. 
• Treatment with anti-obesity medicine with GLP-1, such as semaglutide and exenatide, within 90 days before screening.
• Chronic or intermittent haemodialysis or peritoneal dialysis.

Additional eligibility criteria apply. Please do not hesitate to contact our dedicated Patient Experience team for a detailed discussion about your suitability for participation.

If you are deemed eligible for the study, your participation is expected to be up to 4.7 years (approximately 245 weeks), and you will be required to attend the study site up to 27 times. This includes:

• A screening period of up to 3 weeks, during which you will undergo physical examinations and medical tests to determine your eligibility to participate.  
• Randomisation into the placebo group or the study drug group. 
• A treatment period of up to 4.5 years, during which you will self-administer the study drug or a placebo once weekly. You will also need to attend the study site at various times during your treatment so the research team can track how the product is working for you. 
• A follow-up period of 7 weeks, during which you will revisit the study site so the research team can monitor your progress and generally ensure your well-being. 

This is a double-blind study, which means neither you nor the study doctor will know whether you receive the study drug or a placebo. A placebo resembles the study drug but does not contain any active ingredients. Researchers use a placebo to determine if a study medicine is safer than not taking anything at all. Eligible participants will have a 50% (one in two) chance of receiving the study drug.

Participation in this research study is voluntary, and you may withdraw at any time.

The purpose of this study is to assess the long-term safety of an investigational medicinal product for people with cardiovascular disease, and to determine if it can reduce the risk of serious heart events.

Cardiovascular disease is not a single disease. Also commonly known as heart disease, cardiovascular disease refers to a variety of conditions affecting the heart or blood vessels, including stroke, myocardial infarction (heart attack), and peripheral arterial disease (PAD).

Cardiovascular disease is commonly caused by atherosclerosis, a build-up of fatty deposits in the arteries. These fatty deposits can subsequently narrow and block the arteries, thereby reducing blood flow and increasing the risk of stroke, heart attack, and other heart-related events. 

According to the Australian Heart Foundation, cardiovascular disease is one of the most prevalent conditions in Australia, with more than 16% of the total Australian population self-reporting as living with cardiovascular disease. While many risk factors for cardiovascular disease can be managed through a healthy lifestyle, such as regular exercise and stress reduction, making significant lifestyle changes can be challenging amidst the demands of everyday life. As such, there is a significant need for a safe, effective treatment that helps people with cardiovascular disease regain control of their heart health, get back to doing the things they love, and pave the way for a brighter, more energetic future. The findings from this study could address gaps in how cardiovascular disease is understood and treated - not just among medical professionals, but also the wider community.

This study is being sponsored by Novo Nordisk, a global pharmaceutical company that has been operating for over 100 years. A pioneer in diabetes care, Novo Nordisk now discovers and develops medicines and other treatments for a wide variety of chronic diseases, including obesity. They are committed to addressing the most urgent and widespread health challenges of our time and conduct clinical trials in over 50 countries.

Here is a list of all the that are currently recruiting for this study:

NSW

• Liverpool Hospital : Burnside Dr, Liverpool,  NSW, 2170

• Baker Heart and Diabetes Institute : 75 Commercial Rd, Melbourne, VIC, 3004

WA

• Clinitrials : 146 Mounts Bay Rd, Perth, WA, 6000
• One Clinical Research : 85 Monash Ave, Nedlands, WA ,6009
• Advara HeartCare : Suite 3, Mount Medical Centre, 140 Mounts Bay Road, Perth, WA, 6000

SA

• Royal Adelaide Hospital : Level 4C, Royal Adelaide Hospital, Port Road, Adelaide, 5000

TAS

• Royal Hobart Hospital : 48 Liverpool St, Hobart TAS 7000

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Trial details from ClinicalTrials.gov