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

NCT06035874 | Recruiting DMC

• 1 other identifier: B-LIFTMED001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 2 Diabetes; Non Alcholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• The change in liver fat content

  The primary outcome measure will be the difference of the change in liver fat content from 0 (baseline) to 24 weeks between groups

  Baseline to 24 Weeks

Secondary Outcomes (11)

• The change in pancreatic fat

  Baseline to 24 Weeks

• The change in controlled attenuation parameter

  Baseline to 24 Weeks

• The change in liver stiffness measurement (LSM)

  Baseline to 24 Weeks

• Change between the groups in aspartate aminotransferase (AST) levels

  Baseline to 24 Weeks

• Change between groups in alanine aminotransferase (ALT) levels

  Baseline to 24 Weeks

Study Arms (2)

Bem group

ACTIVE COMPARATOR

Patient will get Bempedoic acid along with the standard of Care

Drug: Bempedoic acid

Control Group

NO INTERVENTION

Patient will get the standard of Care as per routine practice

Interventions

Bempedoic acid DRUG

Patient willl be randomized 1:1 in both the arms

Bem group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.
• 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.
• 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.
• 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.
• 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.
• BMI \>40 kg/m2.
• 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.
• 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.
• Renal disease that required treatment with immunosuppressive therapy or a history of dialysis or renal transplant.
• 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.
• 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.
• Use of vitamin E within 12 weeks before screening.
• History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).
• 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.
• Estimated glomerular filtration rate (eGFR) \<60 mL/min/1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.

Sponsors & Collaborators

• Medanta, The Medicity, India: lead
• Diabetes & Endocrinology Foundation: collaborator

Study Sites (1)

Division Of Endocrinology , Medanta The Medicity Sec 38

Gurgaon, Haryana, 122001, India

RECRUITING

Related Publications (7)

• Malik SM, Devera ME, Fontes P, Shaikh O, Sasatomi E, Ahmad J. Recurrent disease following liver transplantation for nonalcoholic steatohepatitis cirrhosis. Liver Transpl. 2009 Dec;15(12):1843-51. doi: 10.1002/lt.21943.

  PMID: 19938117 BACKGROUND

• Reeder SB, Cruite I, Hamilton G, Sirlin CB. Quantitative Assessment of Liver Fat with Magnetic Resonance Imaging and Spectroscopy. J Magn Reson Imaging. 2011 Oct;34(4):729-749. doi: 10.1002/jmri.22775. Epub 2011 Sep 16.

  PMID: 22025886 BACKGROUND

• Permutt Z, Le TA, Peterson MR, Seki E, Brenner DA, Sirlin C, Loomba R. Correlation between liver histology and novel magnetic resonance imaging in adult patients with non-alcoholic fatty liver disease - MRI accurately quantifies hepatic steatosis in NAFLD. Aliment Pharmacol Ther. 2012 Jul;36(1):22-9. doi: 10.1111/j.1365-2036.2012.05121.x. Epub 2012 May 3.

  PMID: 22554256 BACKGROUND

• Le TA, Chen J, Changchien C, Peterson MR, Kono Y, Patton H, Cohen BL, Brenner D, Sirlin C, Loomba R; San Diego Integrated NAFLD Research Consortium (SINC). Effect of colesevelam on liver fat quantified by magnetic resonance in nonalcoholic steatohepatitis: a randomized controlled trial. Hepatology. 2012 Sep;56(3):922-32. doi: 10.1002/hep.25731. Epub 2012 Jul 2.

  PMID: 22431131 BACKGROUND

• Loomba R, Sirlin CB, Ang B, Bettencourt R, Jain R, Salotti J, Soaft L, Hooker J, Kono Y, Bhatt A, Hernandez L, Nguyen P, Noureddin M, Haufe W, Hooker C, Yin M, Ehman R, Lin GY, Valasek MA, Brenner DA, Richards L; San Diego Integrated NAFLD Research Consortium (SINC). Ezetimibe for the treatment of nonalcoholic steatohepatitis: assessment by novel magnetic resonance imaging and magnetic resonance elastography in a randomized trial (MOZART trial). Hepatology. 2015 Apr;61(4):1239-50. doi: 10.1002/hep.27647. Epub 2015 Feb 27.

  PMID: 25482832 BACKGROUND

• Sanjay KV, Vishwakarma S, Zope BR, Mane VS, Mohire S, Dhakshinamoorthy S. ATP citrate lyase inhibitor Bempedoic Acid alleviate long term HFD induced NASH through improvement in glycemic control, reduction of hepatic triglycerides & total cholesterol, modulation of inflammatory & fibrotic genes and improvement in NAS score. Curr Res Pharmacol Drug Discov. 2021 Sep 4;2:100051. doi: 10.1016/j.crphar.2021.100051. eCollection 2021.

  PMID: 34909677 BACKGROUND

• Bentanachs R, Velazquez AM, Sanchez RM, Alegret M, Laguna JC, Roglans N. Bempedoic acid as a PPARalpha activator: new perspectives for hepatic steatosis treatment in a female rat experimental model. Clin Investig Arterioscler. 2022 Mar-Apr;34(2):57-67. doi: 10.1016/j.arteri.2021.09.004. Epub 2021 Dec 6. English, Spanish.

  PMID: 34887111 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Mr Surender, PhD

CONTACT

01244141414; yadavsurender89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Division of Endocrinology & Diabetes

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: October 15, 2023
• Primary Completion: November 1, 2024
• Study Completion: October 1, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

IN (1)