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

NCT03953456 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-08-31

No results posted yet for this study

Summary

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

Conditions

  • Non-Alcoholic Fatty Liver

Interventions

DRUG

elafibranor 120mg

elafibranor 120mg is a coated tablet for oral administration, once daily

DRUG

Placebo

Placebo is a coated tablet for oral administration, once daily

Sponsors & Collaborators

  • Genfit

    lead INDUSTRY

Principal Investigators

  • Pascal Birman, MD · Genfit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-16
Primary Completion
2020-03-11
Completion
2020-07-14

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03953456 on ClinicalTrials.gov