Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes: Randomized Controlled Trial
Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as type 2 diabetes, metabolic syndrome and dyslipidemia. Bempedoic acid, an ATP-citrate lyase inhibitor, is recently approved for patients with dyslipidemia as a second line drug. Bempedoic acid reduces liver fat in mice model of NASH. Data regarding the effect of bempedoic acid on human liver fat are scarce. Therefore, the current study is planned to evaluate the effect of bempedoic acid versus standard treatment on liver and pancreatic fat content in patients with NAFLD
• A man or woman, 20 years of age or above with the diagnosis of type 2 diabetes for at least 3 months who meets all the following two criteria:
‣ On standard anti-diabetic agents (metformin, DPP-4 inhibitors, sulphonylureas or insulin, in any combination) with an HbA1c of \<9% at screening
⁃ Have documented hepatic steatosis (MRI-PDFF \>5.6%) on screening MRI- PDFF
• Participants must be medically stable based on medical history, physical examination and laboratory investigations.
• Participants must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
• Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.