Overview
Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes
Status:
Recruiting
Recruiting
Trial end date:
2024-12-01
2024-12-01
Target enrollment:
0
0
Participant gender:
All
All
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 NAFLDPhase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Medanta, The Medicity, IndiaCollaborator:
Diabetes & Endocrinology FoundationTreatments:
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Criteria
Inclusion Criteria:1. 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:
1. On standard anti-diabetic agents (metformin, DPP-4 inhibitors, sulphonylureas or
insulin, in any combination) with an HbA1c of <9% at screening
2. Have documented hepatic steatosis (MRI-PDFF >5.6%) on screening MRI- PDFF
2. Participants must be medically stable based on medical history, physical examination
and laboratory investigations.
3. Participants must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol.
4. 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.
Exclusion Criteria:
1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell
transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
2. History of brittle or labile glycemic control, with widely varying glucose
measurements by FPG or SMBG such that stable glucose control over the treatment period
would be unlikely.
3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of
Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an
Alcohol Use Disorders Identification Test (AUDIT) with a score >8, or alcohol
consumption of more than 20 g per day in the case of women and more than 30 g per day
in the case of men for at least three consecutive months during the previous 5 years.
4. Thyroid stimulating hormone (TSH) value that is either < 0.45 mIU/L or >10 mIU/L at
Screening. Note: Subjects on thyroid hormone replacement therapy must be on a stable
dose and dosing regimen for at least 4 weeks prior to enrollment.
5. Use of a PPAR-γ agonist [e.g., a thiazolidinedione (pioglitazone], an SGLT2 inhibitor
(e.g., canagliflozin, empagliflozin, dapagliflozin), GLP-1 receptor agonists (e.g.,
liraglutide, dulaglutide) or saroglitazar (Dual PPARα/γ agonist) within 12 weeks
before the enrollment.
6. BMI >40 kg/m2.
7. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks
before the Screening visit, defined as an increase or decrease of 5% in body weight
based upon clinic-based measurement or, if not available, based on subject's report.
8. Use of weight loss medication (prescription and/or over the counter) within 3 months
prior to Screening or have participated in a weight loss/diet program within 12 months
prior to Screening.
9. Renal disease that required treatment with immunosuppressive therapy or a history of
dialysis or renal transplant.
10. Myocardial infarction, unstable angina, pulmonary hypertension, revascularization
procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3
months before Screening, or revascularization procedure is planned, or subject has a
history of New York Heart Association (NYHA) Class III-IV cardiac disease.
11. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV)
positive, or other clinically active liver disease, or tests positive for HBsAg or
anti- HCV at Screening.
12. Use of vitamin E within 12 weeks before screening.
13. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper
gastrointestinal surgical procedure (including gastric resection).
14. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including
postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any
other chronic, clinically important gastrointestinal disorder.
15. Estimated glomerular filtration rate (eGFR) <60 mL/min/1•73 m2 using the Modification
of Diet in Renal Disease Study (MDRD) equation.
16. Subjects with a history of having or possibly having metallic material in the body or
any contraindication for a MR examination.
17. Claustrophobia, or anxiety related to previous negative experiences with magnetic
resonance imaging procedures or if the subject is unwilling to participate in magnetic
resonance imaging procedures.
18. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative
bone marrow disorder, thrombocytopenia) at Screening.
19. History of human immunodeficiency virus (HIV) antibody positive at Screening.
20. Major surgery (e.g., requiring general anesthesia) within 12 weeks before Screening,
or will not have fully recovered from surgery, or has surgery planned during the time
the subject is expected to participate in the study.
21. Contraindications to the use of bempedoic acid (per BEMPEDOIC ACID Prescribing
Information).
22. Current use of a corticosteroid medication or immunosuppressive agent, or likely to
require treatment with a corticosteroid medication or an immunosuppressive agent.