Why might I want to take part?
Keeping your low-density lipoprotein (LDL) cholesterol (“bad cholesterol”) levels under control is very important to reduce the risk of cardiovascular problems like a heart attack
or stroke. But many people do not get enough benefit from existing medications, and need new, convenient treatment options.
That’s why the AZURE-LDL clinical study is looking at whether an investigational drug called AZD0780 may help. This quick summary explains what to expect if you did choose to take part.
AZD0780 is a type of drug called a PCSK9 inhibitor. These drugs block a protein (PCSK9) that increases LDL cholesterol levels in your blood. This may help to reduce LDL cholesterol levels and protect cardiovascular health.
Some PCSK9 inhibitors are already approved as treatments for high cholesterol, but they are all given as injections. AZD0780 is taken by mouth as a tablet, once each day — we think this may be easier and more convenient for some people.
Will I definitely receive AZD0780 if I take part?
If you do take part, you’ll have a 1 in 2 (50%) chance of receiving AZD0780 (and a 1 in 2 chance of receiving a placebo*). Throughout the study, you’ll be able to keep taking your usual cholesterol-lowering treatments.
*The placebo looks like AZD0780, and is taken the same way, but it does not contain any medicine.
What can I expect if I take part?
In total, you may need to come for up to 11 visits over 56 weeks. This is split into 3 parts:
(1) Screening
To make sure the study is right for you
(2)Study treatment
Start taking AZD0780 or the placebo
(3)Follow-up
To check your health and well-being
During visits, you’ll meet with the study team to discuss your health and have tests and assessments, including heart tests (electrocardiograms) and blood and urine tests.
At home, you’ll need to:
• Take the study treatment, by mouth, once each day
• Fast before each visit
• Avoid any changes in your exercise routine before visits
• Follow a heart-healthy diet
Does AZD0780 have any side effects?
As with all medicines, AZD0780 may cause some side effects. In previous studies, AZD0780 was well tolerated, with some non-serious side effects reported. The study doctor will discuss side effects with you in detail, and will closely monitor your health and well-being at all times during the study.
Will it cost anything to take part?
It will not cost anything to take part, and you may be paid back for any travel or parking costs during visits. However, if you have health insurance, it’s important to discuss with your provider whether taking part may affect your cover.
