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Clinical Trial Details

Trial ID: L3171
Source ID: NCT06035874
Associated Drug: Bempedoic Acid
Title: Effect of Bempedoic Acid on Liver Fat in Individuals With Nonalcoholic Fatty Liver Disease and Type 2 Diabetes
Acronym: B-LIFT
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Non Alcholic Fatty Liver Disease
Interventions: DRUG: Bempedoic acid
Outcome Measures: Primary: 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: The change in pancreatic fat, The difference of the change in pancreatic fat content from 0 (baseline) to 24 weeks between groups. \[Pancreatic fat content as quantified by MRI PDFF\], 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. \[CAP will be assessed by transient elastography\]., 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. \[LSM will be measured by transient elastography\]., Baseline to 24 Weeks|Change between the groups in aspartate aminotransferase (AST) levels, Change between the groups in aspartate aminotransferase (AST) levels, Baseline to 24 Weeks|Change between groups in alanine aminotransferase (ALT) levels, Change between groups in alanine aminotransferase (ALT) levels, Baseline to 24 Weeks|Change between groups in gamma-glutamyl transpeptidase (GGT) levels., Change between groups in gamma-glutamyl transpeptidase (GGT) levels., Baseline to 24 Weeks|Change between the groups in serum creatinine concentrations., Change between the groups in serum creatinine concentrations., Baseline to 24 Weeks|Change between the groups in total cholesterol levels., Change between the groups in total cholesterol levels., Baseline to 24 Weeks|Change between groups in triglycerides levels., Change between groups in triglycerides levels., Baseline to 24 Weeks|Change between groups in LDL levels, Change between groups in LDL levels, Baseline to 24 Weeks|Change between groups in HDL levels, Change between groups in HDL levels, Baseline to 24 Weeks
Sponsor/Collaborators: Sponsor: Medanta, The Medicity, India | Collaborators: Diabetes & Endocrinology Foundation
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-15
Completion Date: 2025-02-01
Results First Posted:
Last Update Posted: 2024-12-27
Locations: Division Of Endocrinology , Medanta The Medicity Sec 38, Gurgaon, Haryana, 122001, India
URL: https://clinicaltrials.gov/show/NCT06035874