This randomized, double-blind, cross-over (placebo or elafibranor \[GFT505\]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an adult NAFL population after 6 weeks of treatment with a 4-week wash-out period. This study will achieve mechanistic information about the mode of action of Elafibranor on the (lipid) metabolism in the human fatty liver
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
elafibranor 120mg is a coated tablet for oral administration, once daily
Placebo is a coated tablet for oral administration, once daily
NUTRIM School of Nutrition and Translational Research in Metabolism
Maastricht, Netherlands
Change in relative amount of saturated fatty acids in the liver
Relative amount of saturated fatty acids (SFA) in the liver measured by Magnetic Resonance Spectroscopy (1H-MRS) at the end of 6 weeks treatment period
Time frame: After 6 weeks
Change in hepatic insulin sensitivity
Hepatic insulin sensitivity measured by Hepatic Glucose Production (HGP) at the end of 6 weeks treatment period
Time frame: After 6 weeks
Glucose homeostasis markers
Fasting glycemia
Time frame: After 6 weeks
Glucose homeostasis markers
HbA1c
Time frame: After 6 weeks
Glucose homeostasis markers
Fasting insulinemia
Time frame: After 6 weeks
Glucose homeostasis markers
C-peptide
Time frame: After 6 weeks
Glucose homeostasis markers
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index
Time frame: After 6 weeks
Glucose homeostasis markers
Fructosamine
Time frame: After 6 weeks
Lipid metabolism markers
Triglycerides (TG)
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Time frame: After 6 weeks
Lipid metabolism markers
Total cholesterol (TC)
Time frame: After 6 weeks
Lipid metabolism markers
High density lipoprotein-cholesterol (HDL-C)
Time frame: After 6 weeks
Lipid metabolism markers
Low density lipoprotein-cholesterol (LDL-C)
Time frame: After 6 weeks
Lipid metabolism markers
Non-HDL-C
Time frame: After 6 weeks
Lipid metabolism markers
Free fatty acid (FFA)
Time frame: After 6 weeks
Inflammatory markers
High sensitivity C-reactive protein (hs-CRP)
Time frame: After 6 weeks
Inflammatory markers
Fibrinogen
Time frame: After 6 weeks
Inflammatory markers
Haptoglobin
Time frame: After 6 weeks
Liver function
Alanine aminotransferase (ALT)
Time frame: After 6 weeks
Liver function
Aspartate aminotransferase (AST)
Time frame: After 6 weeks
Liver function
Gamma glutamyl transferase (GGT)
Time frame: After 6 weeks
Liver function
Alkaline phosphatase (ALP)
Time frame: After 6 weeks
Liver function
Total and conjugated bilirubin
Time frame: After 6 weeks
Renal function
Creatinine
Time frame: After 6 weeks
Renal function
Estimated glomerular filtration rate (using Modification of Diet in Renal Disease (MDRD) formula)
Time frame: After 6 weeks
Renal function
Blood urea nitrogen
Time frame: After 6 weeks
Renal function
Albumin
Time frame: After 6 weeks
Renal function
Uric acid
Time frame: After 6 weeks
Renal function
Total proteins
Time frame: After 6 weeks
Body weight
Time frame: After 6 weeks
Body Mass Index
Time frame: After 6 weeks
Waist circumference
Time frame: After 6 weeks
Incidence and severity of treatment emergent adverse events (TEAEs) and their relationship to study drug
Time frame: After 6 weeks
Incidence of clinically meaningful changes from baseline in safety laboratory parameters, and vital signs
Time frame: After 6 weeks