A Study to Evaluate the Effectiveness and Safety of Elafibranor for Patients with Nonalcoholic Fatty Liver Disease


About this study

The first double-blind 72-week treatment period will assess the efficacy and safety of elafibranor on the resolution of NASH without worsening of fibrosis at the intermediate efficacy analysis, followed by a Long-term Treatment Period to assess efficacy on all-cause mortality and liver-related clinical outcomes as measured by the time to first occurrence of any of the listed adjudicated events (all-cause mortality, progression to histological cirrhosis, and the full list of portal hypertension/cirrhosis related events).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Males or females
  • Age 18 to 75 years inclusive at first screening visit
  • Must provide signed written informed consent and agree to comply with the study protocol
  • BMI ≤ 45 kg/m²
  • Females participating in the study must either be
    • Not of childbearing potential
      • Hysterectomy
      • Bilateral oophorectomy
      • Medically documented ovarian failure
      • > 50 years of age with cessation of menses for at least 12 months due to ovarian failure
    • Using efficient double contraception for the full duration of the study and for 1 month after the end of treatment
      • Hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device, or other mechanical contraception method 
      • condom or diaphragm, with  spermicide
  • Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides with at least 1 in each component of the NAS score
    • Biopsy obtained within 6 months prior to randomization or during the screening period
    • Steatosis scored 0-3
    • Ballooning degeneration scored 0-2
    • Lobular inflammation scored 0-3
  • NAS score ≥ 4
  • Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system
  • Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
  • No change in antidiabetic therapy within 6 months prior to liver biopsy

Exclusion Criteria

  • Known heart failure Grade I to IV of New York Heart Association classification
  • History of efficient bariatric surgery within 5 years prior to screening
  • Uncontrolled hypertension 
  • Type 1 diabetes
  • Decompensated diabetes (HbA1c>9%)
  • A history of clinically significant acute cardiac event within 6 months prior to screening 
  • Weight loss of more than 5% within 6 months prior to randomization 
  • Compensated and decompensated cirrhosis
  • Current or recent history (< 5 years) of significant alcohol consumption 
  • Pregnant or lactating or planning to become pregnant during the study period
  • Other well documented causes of chronic liver disease according to standard diagnostic procedures 
  • Previous exposure to Elafibranor 
  • Prohibited concomitant medication 
  • Any medical conditions that may diminish life expectancy to less than 2 years including known cancers
  • Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease
  • Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Maria Yataco, M.D.

Closed for enrollment

More information


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