This trial is examining how effective the drug bempedoic acid is when used with ezetimibe (Zetia) to reduce cholesterol in patients with type 2 diabetes (T2D). The main outcome will be the measurement of patient’s cholesterol as well as heart disease risk, diabetes severity and drug side effects. This study is recruiting in the United States: Lincoln, CA, Miami, FL, Louisville, KY and Suffolk, VA.
The details
Patients with T2D often develop other health problems such as high cholesterol. High cholesterol occurs when there are too many fats in the blood. These build up and can lead to problems such as heart disease. Ezetimibe is a drug commonly used to reduce cholesterol in patients with diabetes; however, it is not fully effective.
This trial aims to see if adding new cholesterol-lowering drug bempedoic acid to ezetimibe will help reduce cholesterol in patients with T2D. The main outcome will be measured as a change in LDL (low-density lipoprotein) cholesterol ("bad" cholesterol) and other cholesterol types.
Who are they looking for?
This study is recruiting 234 patients diagnosed with T2D over 6 months ago. Patients should be aged between 18 and 75 and be taking diabetic medication for more than 3 months. Patient’s HbA1c (blood glucose control over the past 3 months) levels should be between 7-10%. Patient’s LDL-cholesterol must be greater than 70 mg/dL. Female patients of child bearing age should not be pregnant or breastfeeding and must agree to use contraception for the duration of the trial and up to 30 days after it finishes.
Patients should not have a body mass index (BMI) of 40 kg/m2 or higher (obese class III). Patients with a family history of severe heart disease or type 1 diabetes cannot participate. Patients with high fasting blood fat levels (over 400 mg/dL) cannot participate. Patients with untreated thyroid, liver, kidney or intestinal problems cannot participate. Patients with alcohol or drug abuse problems in the last 2 years cannot participate.
How will it work
There will be three groups in this study. The first group will receive bempedoic acid and ezetimibe. The second group will receive ezetimibe and a placebo. The third group will receive a placebo alone.
LDL cholesterol will be measured in patients for 12 weeks. Other types of cholesterol, indicators of heart disease, HbA1c levels, insulin resistance and side effects of treatment will also be measured for 12 weeks.
