Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)

Conditions

• Non-Alcoholic Fatty Liver

Eligibility Criteria

Sex

ALL

Age

40 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• elafibranor 120mg — DRUG
  elafibranor 120mg is a coated tablet for oral administration, once daily
• Placebo — DRUG
  Placebo is a coated tablet for oral administration, once daily

Study Details

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

Key Dates

Start date

Aug 16, 2019

Status verified

Aug 2020

Primary completion

Mar 11, 2020

Completion

Jul 14, 2020

Study Design

Enrollment

17 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: elafibranor 120mg followed by placebo
  Participants will first receive elafibranor 120mg for 6 weeks. After a washout period of 4-6 weeks, they will then receive placebo for 6 weeks
• Placebo Comparator: placebo followed by elafibranor 120mg
  Participants will first receive placebo for 6 weeks. After a washout period of 4-6 weeks, they will then receive elafibranor 120mg for 6 weeks

Primary Outcome Measure

Change in relative amount of saturated fatty acids in the liver [ Time Frame: After 6 weeks ]