RecruitingNot ApplicableNCT06035874

Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes

Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes: Randomized Controlled Trial

Sponsor

Medanta, The Medicity, India

Enrollment

100 participants

Start Date

Oct 15, 2023

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Non Alcholic Fatty Liver Disease

Summary

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

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether bempedoic acid — a cholesterol-lowering medication — can also reduce fat build-up in the liver in people with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD), a condition where excess fat accumulates in the liver. **You may be eligible if...** - You are 20 or older - You have type 2 diabetes for at least 3 months, managed with standard medications - Your blood sugar is reasonably controlled (HbA1c under 9%) - An MRI scan has confirmed excess liver fat (above 5.6%) - You are medically stable **You may NOT be eligible if...** - You have type 1 diabetes or a history of diabetic ketoacidosis - You drink alcohol excessively - You are currently taking certain diabetes or liver medications (like pioglitazone, SGLT2 inhibitors, or GLP-1 agonists) - You have a thyroid disorder that is not well-controlled - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.