Actively Recruiting
Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes
Led by Medanta, The Medicity, India · Updated on 2025-06-13
100
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
Sponsors
M
Medanta, The Medicity, India
Lead Sponsor
D
Diabetes & Endocrinology Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 20 years or older with type 2 diabetes diagnosed for at least 3 months
- On standard anti-diabetic medications (metformin, DPP-4 inhibitors, sulphonylureas, or insulin) with HbA1c below 9% at screening
- Documented hepatic steatosis with MRI-PDFF liver fat above 5.6% on screening
- Medically stable based on history, exam, and lab tests
- Willing and able to follow study restrictions
- Signed informed consent form indicating understanding of the study and willingness to participate
You will not qualify if you...
- History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplant, or diabetes due to pancreatitis or pancreatectomy
- Unstable or brittle blood sugar control making stable treatment unlikely
- Drug or alcohol abuse in past 3 years or high alcohol consumption recently
- Thyroid hormone levels outside normal range or unstable thyroid therapy
- Use of certain diabetes or weight loss medications in past 12 weeks
- Body mass index over 40 kg/m2
- Recent significant weight change or eating disorder
- Use of weight loss medications or programs recently
- Kidney disease requiring immunosuppressive therapy, dialysis, or transplant
- Recent heart attack, unstable angina, pulmonary hypertension, or severe heart disease
- Positive hepatitis B or C tests or other active liver diseases
- Use of vitamin E in past 12 weeks
- History of major gastrointestinal surgery
- Gastrointestinal disorders like gastroparesis or inflammatory bowel disease
- Reduced kidney function (eGFR below 60 mL/min/1.73 m2)
- Presence of metal in body or MRI contraindications
- Claustrophobia or anxiety preventing MRI participation
- Significant blood disorders
- Positive HIV test
- Major surgery within past 12 weeks or planned
- Contraindications to bempedoic acid use
- Current or likely use of corticosteroids or immunosuppressive drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Division Of Endocrinology , Medanta The Medicity Sec 38
Gurgaon, Haryana, India, 122001
Actively Recruiting
Research Team
M
Mr Surender, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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