Ensayos clínicos

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