RUBENS - Clinical Trial
What is the Purpose of this Study?
People in this study will take part for about one year. At the beginning, they will be placed into one of three groups by chance, like flipping a coin. One group will take two study medicines together. Another group will take one study medicine by itself. The third group will take a placebo, which looks like medicine but has no active drug. For the first twelve weeks, neither the participants nor the study team will know which pills are taken. During this time, people will take pills once a day, come to study visits, and have blood tests and health checks. After the first twelve weeks, everyone will take the two study medicines together for nine more months, with regular clinic visits and tests to check cholesterol levels and safety.
This study is for adults who have high levels of bad cholesterol called LDL cholesterol that are still too high even though they take cholesterol medicine. People in the study may have type 2 diabetes, metabolic syndrome, or both. Metabolic syndrome means having several health problems like high blood sugar, high blood pressure, extra weight around the waist, or unhealthy cholesterol levels. The goal of the study is to see how well the study medicines can lower bad cholesterol and how safe they are to use.
Who Can Participate in the Study?
Adults who are 18 years old or older may be able to join this study if they have type 2 diabetes, metabolic syndrome, or both. They must have high levels of bad cholesterol, called LDL cholesterol, shown by a blood test. They should already be taking cholesterol lowering medicine or be unable to take it because of side effects. People cannot join if they have serious health problems, such as very high blood pressure that is not controlled, severe heart failure, or active liver disease.
What is Involved?
This study is being done to see how well new study medicines can lower bad cholesterol, also called LDL cholesterol, in people who have type 2 diabetes, metabolic syndrome, or both. These people already take cholesterol medicines, but their cholesterol is still too high. The study also checks if the medicines are safe when taken for a long time. The goal is to find better ways to lower cholesterol and help reduce the chance of future heart problems.
Study Details
