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

Sponsor
Medanta, The Medicity, India
Study ID
NCT06035874
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bempedoic acid — DRUG
    Patient willl be randomized 1:1 in both the arms

Study Details

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

Key Dates

Start date
Oct 15, 2023
Status verified
Jun 2025
Primary completion
Nov 1, 2024
Completion
Oct 1, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bem group
    Patient will get Bempedoic acid along with the standard of Care
  • No Intervention: Control Group
    Patient will get the standard of Care as per routine practice

Primary Outcome Measure

The change in liver fat content [ Time Frame: Baseline to 24 Weeks ]

Central Contacts

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