Type 2 DiabetesB-LIFTNCT06035874
Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes
A study testing Bempedoic acid in people with Type 2 Diabetes and Non Alcholic Fatty Liver Disease, run by Medanta, The Medicity, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes, Non Alcholic Fatty Liver Disease
- What is being tested?
- Bempedoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 15 Oct 2023to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.
- 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.
- Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.
- History of human immunodeficiency virus (HIV) antibody positive at Screening.
- 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.
- Contraindications to the use of bempedoic acid (per BEMPEDOIC ACID Prescribing Information).
- Current use of a corticosteroid medication or immunosuppressive agent, or likely to require treatment with a corticosteroid medication or an immunosuppressive agent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
Division Of Endocrinology , Medanta The Medicity Sec 38
Gurgaon, Haryana, 122001
Mohammad S kuchay, MBBS, MD, 0124-4141414 ext. 6596, drshafikuchay@gmail.con
Surender Rao, Msc, 0124-4141414 ext. 6596, yadavsurender89@gmail.com
About this study
Official title: 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
Read the detailed description
OBJECTIVE 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.
Materials and methods
Study design This B-LIFT (effect of Bempedoic acid on Liver fat content) trial is an investigator initiated, open label, randomized clinical study to examine the effect of bempedoic acid 180 mg tablet once a day for 24 weeks (Bemp group) versus standard treatment (control group) on liver and pancreatic fat content. Hepatic steatosis (intracellular fat accumulation in hepatocytes) will be measured by MRI-PDFF, a validated quantitative biomarker for liver fat. Controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) will be measured by Fibroscan. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine out-patient clinic, who would primarily visit for management of type 2 diabetes and other co-morbidities. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial. The study will be registered at clinicaltrials.gov. The clinical trial protocol will be presented for approval to the institutional ethics review board. Informed written consent will be obtained from all the participants before enrolment into the study.
All patients will undergo a baseline assessment before randomization, including detailed medical history, physical examination including anthropometry and biochemical evaluation.
Randomization
A research assistant will randomize the patients into Bem group or Control group in a 1:1 ratio using computer-generated numbers. It will be ensured that these are equal in number. Opaque envelopes will be prepared with serial number on the top and the assigned group inside the envelop. After recruiting the subjects, the envelop with corresponding serial number will be opened and the subjects assign to the relevant groups after opening the envelop. The patients will then be sent back to their respective consultants in the endocrine department for initiation and/or adjustment of treatment for type 2 diabetes (according to randomization into Bemp or control groups) and other co-morbidities.
Study visits
After careful assessment at the baseline visit, patients meeting all inclusion and exclusion criteria will be randomized to receive bempedoic acid 180 mg once a day or the standard treatment (no treatment for fatty liver, control group) for 24 weeks. Patients will be advised to return to the out-patient endocrine clinic for follow-up visits at weeks 12 and 24.
Primary outcome The primary outcome measure will be the difference of the change in liver fat content from 0 (baseline) to 24 weeks between groups. [liver fat content as quantified by MRI-PDFF in colocalized regions of interest (ROI) within each of the nine liver segments].
Secondary outcomes
- The difference of the change in pancreatic fat content from 0 (baseline) to 24 weeks between groups. [Pancreatic fat content as quantified by MRI PDFF].
- The difference of the change in controlled attenuation parameter (CAP) from 0 (baseline) to 24 weeks between groups. [CAP will be assessed by transient elastography].
- The difference of the change in liver stiffness measurement (LSM) from 0 (baseline) to 24 weeks between groups. [LSM will be measured by transient elastography].
- Change between the groups in aspartate aminotransferase (AST) levels.
- Change between groups in alanine aminotransferase (ALT) levels.
- Change between groups in gamma-glutamyl transpeptidase (GGT) levels.
- Change between the groups in serum creatinine concentrations.
- Change between the groups in total cholesterol levels.
- Change between groups in triglycerides levels.
- Change between groups in LDL levels.
- Change between groups in HDL levels.
MRI-PDFF protocols
MRI-PDFF for fat quantification
MRI-PDFF is a non-invasive, objective, and quantitative MR imaging-based biomarker that can accurately estimate liver fat. MRI-PDFF has been demonstrated to be a robust technique for assessing treatment response in NASH clinical trials. In this study, the time interval from obtaining the baseline MRI-PDFF to initiating the study drug will be less than one week.
MRI-PDFF for detailed fat mapping of the entire liver
All MR examinations will be done by an experienced MR technologist in the Medanta Radiology department under the direction of the radiologist investigator (SK). The radiologist investigator, blinded to the patients' treatment group allocation, clinical and biochemical data, and order of scans (baseline and follow-up), will perform the image analyses.
ROI colocalization before and after treatment
To assess longitudinal changes in liver fat content, one colocalized ROI will be placed in each of the nine liver segments (nine separate ROIs) on the baseline and follow-up MRI examinations.
Statistical analysis Plan
The analysis will include profiling of patients on different demographic, clinical and laboratory parameters etc. Quantitative data will be presented in terms of means and standard deviation and qualitative/categorical data will be presented as absolute numbers and proportions. To compare between the two groups, the Chi-squared test or Fisher's exact test will be used for categorical variables, and the independent samples t test or Wilcoxon-Mann-Whitney U test will be used for the differences between continuous variables. Pearson correlation coefficient will be used to evaluate correlations between variables. Additional analyses of primary and secondary outcomes within treatment groups will be performed by using two-tailed independent sample t tests, paired t tests, or non-parametric tests, when indicated. P-value < 0.05 is considered statistically significant. SPSS software will be used for analysis.
Sample size calculation
Investigator assumed that a 5.0% difference in absolute liver fat content between bempedoic acid versus control group would be the minimally appreciable and clinically relevant difference. Based on the results of previous similar clinical studies involving ezetimibe and empagliflozin, Investigator expected the bempedoic acid group to have a liver fat reduction of >5% compared to baseline, and control group to have <2% reduction in liver fat compared to baseline. With these assumptions the sample size per group works out as 30 in each group to achieve a power of at least 90% with a β of 0.05. Therefore, Investigator plan to randomize 100 patients, 50 in each group to ensure adequate study power even with dropouts.
Method of sample size calculation
Assumptions:
Change in absolute liver fat from baseline to week 24 in Bemp group (m1) = 5.0% Change in absolute liver fat from baseline to week 24 in Control group (m2) = 2.0% Confidence level -95% Power - 90% Coefficient of variation = 100%
Formula for sample size calculation:
n = (Zα+Zβ)2 * (σ12 + σ22)) / (m1-m2)2, where Zα is the value of normal distribution corresponding to desired confidence level Zβ is the value of the Normal distribution corresponding to desired power σ1 and σ2 are the standard deviation of the two groups With these assumptions the sample size per group works out as 30. Investigator will randomize 50 in each group to ensure adequate power even after dropouts.
Patient confidentiality
Precautions will be taken to ensure confidentiality. Data collection forms will not reveal the name of patients included in study. All the participants will be covered by insurance to cover the cost of any untoward effect directly resulting from enrolment in the study.
- Conditions
- Type 2 Diabetes, Non Alcholic Fatty Liver Disease
- Being tested
- Bempedoic acid
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic acidDrug
Patient willl be randomized 1:1 in both the arms
| Study group | Role | What they receive |
|---|---|---|
| Bem group | Active comparator | Patient will get Bempedoic acid along with the standard of Care Receives: Drug: Bempedoic acid |
| Control Group | No intervention | Patient will get the standard of Care as per routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 24 Weeks
Secondary outcomes (11)
The change in pancreatic fat
The difference of the change in pancreatic fat content from 0 (baseline) to 24 weeks between groups. [Pancreatic fat content as quantified by MRI PDFF]
Measured: Baseline to 24 Weeks
The change in controlled attenuation parameter
The difference of the change in controlled attenuation parameter (CAP) from 0 (baseline) to 24 weeks between groups. [CAP will be assessed by transient elastography].
Measured: Baseline to 24 Weeks
The change in liver stiffness measurement (LSM)
The difference of the change in liver stiffness measurement (LSM) from 0 (baseline) to 24 weeks between groups. [LSM will be measured by transient elastography].
Measured: Baseline to 24 Weeks
Change between the groups in aspartate aminotransferase (AST) levels
Change between the groups in aspartate aminotransferase (AST) levels
Measured: Baseline to 24 Weeks
Change between groups in alanine aminotransferase (ALT) levels
Change between groups in alanine aminotransferase (ALT) levels
Measured: Baseline to 24 Weeks
Change between groups in gamma-glutamyl transpeptidase (GGT) levels.
Change between groups in gamma-glutamyl transpeptidase (GGT) levels.
Measured: Baseline to 24 Weeks
Change between the groups in serum creatinine concentrations.
Change between the groups in serum creatinine concentrations.
Measured: Baseline to 24 Weeks
Change between the groups in total cholesterol levels.
Change between the groups in total cholesterol levels.
Measured: Baseline to 24 Weeks
Change between groups in triglycerides levels.
Change between groups in triglycerides levels.
Measured: Baseline to 24 Weeks
Change between groups in LDL levels
Change between groups in LDL levels
Measured: Baseline to 24 Weeks
Change between groups in HDL levels
Change between groups in HDL levels
Measured: Baseline to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Oct 2023
- Primary completion1 Nov 2024
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medanta, The Medicity, India
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes & Endocrinology Foundation
- Responsible party
- Principal investigator, Dr Mohammad Shafi Kuchay, Medanta, The Medicity, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035874
- Sponsor's protocol ID
- B-LIFTMED001
- Acronym
- B-LIFT
- Status last verified
- Jun 2025
- First submitted
- 6 Sep 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19938117Reeder 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.
PubMed 22025886Permutt 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.
PubMed 22554256Le 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.
PubMed 22431131Loomba 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.
PubMed 25482832Sanjay 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.
PubMed 34909677Bentanachs 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.
PubMed 34887111
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06035874
- Acronym / sponsor ID
- B-LIFT / B-LIFTMED001
- Conditions
- Type 2 Diabetes, Non Alcholic Fatty Liver Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medanta, The Medicity, IndiaUniversity, hospital or other
- Collaborators
- Diabetes & Endocrinology Foundation
- Study start
- 15 Oct 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVE 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.
Materials and methods
Study design This B-LIFT (effect of Bempedoic acid on Liver fat content) trial is an investigator initiated, open label, randomized clinical study to examine the effect of bempedoic acid 180 mg tablet once a day for 24 weeks (Bemp group) versus standard treatment (control group) on liver and pancreatic fat content. Hepatic steatosis (intracellular fat accumulation in hepatocytes) will be measured by MRI-PDFF, a validated quantitative biomarker for liver fat. Controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) will be measured by Fibroscan. The study will be conducted according to the CONSORT guidelines. The patient population for the trial will be derived from Medanta-The Medicity Hospital endocrine out-patient clinic, who would primarily visit for management of type 2 diabetes and other co-morbidities. The study will be conducted in Medanta-The Medicity Hospital, Gurugram, Haryana, which is a tertiary care center in North India. Patients deemed eligible will be screened for the trial. The study will be registered at clinicaltrials.gov. The clinical trial protocol will be presented for approval to the institutional ethics review board. Informed written consent will be obtained from all the participants before enrolment into the study.
All patients will undergo a baseline assessment before randomization, including detailed medical history, physical examination including anthropometry and biochemical evaluation.
Randomization
A research assistant will randomize the patients into Bem group or Control group in a 1:1 ratio using computer-generated numbers. It will be ensured that these are equal in number. Opaque envelopes will be prepared with serial number on the top and the assigned group inside the envelop. After recruiting the subjects, the envelop with corresponding serial number will be opened and the subjects assign to the relevant groups after opening the envelop. The patients will then be sent back to their respective consultants in the endocrine department for initiation and/or adjustment of treatment for type 2 diabetes (according to randomization into Bemp or control groups) and other co-morbidities.
Study visits
After careful assessment at the baseline visit, patients meeting all inclusion and exclusion criteria will be randomized to receive bempedoic acid 180 mg once a day or the standard treatment (no treatment for fatty liver, control group) for 24 weeks. Patients will be advised to return to the out-patient endocrine clinic for follow-up visits at weeks 12 and 24.
Primary outcome The primary outcome measure will be the difference of the change in liver fat content from 0 (baseline) to 24 weeks between groups. [liver fat content as quantified by MRI-PDFF in colocalized regions of interest (ROI) within each of the nine liver segments].
Secondary outcomes
- The difference of the change in pancreatic fat content from 0 (baseline) to 24 weeks between groups. [Pancreatic fat content as quantified by MRI PDFF].
- The difference of the change in controlled attenuation parameter (CAP) from 0 (baseline) to 24 weeks between groups. [CAP will be assessed by transient elastography].
- The difference of the change in liver stiffness measurement (LSM) from 0 (baseline) to 24 weeks between groups. [LSM will be measured by transient elastography].
- Change between the groups in aspartate aminotransferase (AST) levels.
- Change between groups in alanine aminotransferase (ALT) levels.
- Change between groups in gamma-glutamyl transpeptidase (GGT) levels.
- Change between the groups in serum creatinine concentrations.
- Change between the groups in total cholesterol levels.
- Change between groups in triglycerides levels.
- Change between groups in LDL levels.
- Change between groups in HDL levels.
MRI-PDFF protocols
MRI-PDFF for fat quantification
MRI-PDFF is a non-invasive, objective, and quantitative MR imaging-based biomarker that can accurately estimate liver fat. MRI-PDFF has been demonstrated to be a robust technique for assessing treatment response in NASH clinical trials. In this study, the time interval from obtaining the baseline MRI-PDFF to initiating the study drug will be less than one week.
MRI-PDFF for detailed fat mapping of the entire liver
All MR examinations will be done by an experienced MR technologist in the Medanta Radiology department under the direction of the radiologist investigator (SK). The radiologist investigator, blinded to the patients' treatment group allocation, clinical and biochemical data, and order of scans (baseline and follow-up), will perform the image analyses.
ROI colocalization before and after treatment
To assess longitudinal changes in liver fat content, one colocalized ROI will be placed in each of the nine liver segments (nine separate ROIs) on the baseline and follow-up MRI examinations.
Statistical analysis Plan
The analysis will include profiling of patients on different demographic, clinical and laboratory parameters etc. Quantitative data will be presented in terms of means and standard deviation and qualitative/categorical data will be presented as absolute numbers and proportions. To compare between the two groups, the Chi-squared test or Fisher's exact test will be used for categorical variables, and the independent samples t test or Wilcoxon-Mann-Whitney U test will be used for the differences between continuous variables. Pearson correlation coefficient will be used to evaluate correlations between variables. Additional analyses of primary and secondary outcomes within treatment groups will be performed by using two-tailed independent sample t tests, paired t tests, or non-parametric tests, when indicated. P-value < 0.05 is considered statistically significant. SPSS software will be used for analysis.
Sample size calculation
Investigator assumed that a 5.0% difference in absolute liver fat content between bempedoic acid versus control group would be the minimally appreciable and clinically relevant difference. Based on the results of previous similar clinical studies involving ezetimibe and empagliflozin, Investigator expected the bempedoic acid group to have a liver fat reduction of >5% compared to baseline, and control group to have <2% reduction in liver fat compared to baseline. With these assumptions the sample size per group works out as 30 in each group to achieve a power of at least 90% with a β of 0.05. Therefore, Investigator plan to randomize 100 patients, 50 in each group to ensure adequate study power even with dropouts.
Method of sample size calculation
Assumptions:
Change in absolute liver fat from baseline to week 24 in Bemp group (m1) = 5.0% Change in absolute liver fat from baseline to week 24 in Control group (m2) = 2.0% Confidence level -95% Power - 90% Coefficient of variation = 100%
Formula for sample size calculation:
n = (Zα+Zβ)2 * (σ12 + σ22)) / (m1-m2)2, where Zα is the value of normal distribution corresponding to desired confidence level Zβ is the value of the Normal distribution corresponding to desired power σ1 and σ2 are the standard deviation of the two groups With these assumptions the sample size per group works out as 30. Investigator will randomize 50 in each group to ensure adequate power even after dropouts.
Patient confidentiality
Precautions will be taken to ensure confidentiality. Data collection forms will not reveal the name of patients included in study. All the participants will be covered by insurance to cover the cost of any untoward effect directly resulting from enrolment in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bem group | Active comparator | Drug: Bempedoic acidPatient will get Bempedoic acid along with the standard of Care |
| Control Group | No intervention | –Patient will get the standard of Care as per routine practice |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic acidPatient willl be randomized 1:1 in both the arms | Drug | Bem group |
Primary outcome
The change in liver fat content
Time frame: Baseline to 24 Weeks
The primary outcome measure will be the difference of the change in liver fat content from 0 (baseline) to 24 weeks between groups
11 secondary outcomes
The change in pancreatic fat
Time frame: Baseline to 24 Weeks
The change in controlled attenuation parameter
Time frame: Baseline to 24 Weeks
The change in liver stiffness measurement (LSM)
Time frame: Baseline to 24 Weeks
Change between the groups in aspartate aminotransferase (AST) levels
Time frame: Baseline to 24 Weeks
Change between groups in alanine aminotransferase (ALT) levels
Time frame: Baseline to 24 Weeks
Change between groups in gamma-glutamyl transpeptidase (GGT) levels.
Time frame: Baseline to 24 Weeks
Change between the groups in serum creatinine concentrations.
Time frame: Baseline to 24 Weeks
Change between the groups in total cholesterol levels.
Time frame: Baseline to 24 Weeks
Change between groups in triglycerides levels.
Time frame: Baseline to 24 Weeks
Change between groups in LDL levels
Time frame: Baseline to 24 Weeks
Change between groups in HDL levels
Time frame: Baseline to 24 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Results publication: PubMed 19938117Malik 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.
- Results publication: PubMed 22025886Reeder 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.
- Results publication: PubMed 22554256Permutt 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.
- Results publication: PubMed 22431131Le 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.
- Results publication: PubMed 25482832Loomba 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.
- Results publication: PubMed 34909677Sanjay 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.
- Results publication: PubMed 34887111Bentanachs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bempedoic acid in people with Type 2 Diabetes and Non Alcholic Fatty Liver Disease, run by Medanta, The Medicity, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mr Surender, PhD (01244141414 ext. 6596, yadavsurender89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in liver fat content (time frame: Baseline to 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035874, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.