Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

Inclusion Criteria:

1. Males or females aged from 18 to 75 years inclusive at first screening visit.
2. Must provide signed written informed consent and agree to comply with the studyprotocol.
3. Females participating in this study must be of nonchildbearing potential or usinghighly efficient contraception for the full duration of the study and for 1 monthafter the end of treatment, as described below:
4. Cessation of menses for at least 12 months due to ovarian failure,
5. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medicallydocumented ovarian failure
6. If requested by local IRB regulations and/or National laws, sexual abstinence maybe considered adequate (the reliability of sexual abstinence needs to beevaluated in relation to the duration of the clinical trial and the preferred andusual lifestyle of the patient)
7. Using a highly effective nonhormonal method of contraception (bilateral tubalocclusion, vasectomized partner, or intra-uterine device)
8. Double contraception with barrier AND highly effective hormonal method ofcontraception (oral, intravaginal, or transdermal combined estrogen andprogestogen hormonal contraception associated with inhibition of ovulation; oral,injectable, or implantable progestogen-only hormonal contraception associatedwith inhibition of ovulation; or intrauterine hormone-releasing system). Thehormonal contraception must be started at least 1 month prior to Randomization.
9. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by centralreading of the slides (biopsy obtained within 6 months prior to randomization orduring the screening period) with at least 1 in each component of the NAS score (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammationscored 0-3).
10. NAS score ≥4.
11. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis stagingsystem.
12. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from atleast 6 months prior to diagnostic liver biopsy
13. For participants with type 2 diabetes, glycemia must be controlled. If glycemia iscontrolled by antidiabetic drugs, change in anti-diabetic therapy must follow theserequirements:
14. No qualitative change 6 months prior to diagnostic liver biopsy up toRandomization (i.e., implementation of a new anti-diabetic therapy) forparticipants treated with metformin, gliptins, sulfonylureas, sodium/glucosecotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, orinsulin. Dose changes of these medications are allowed in the 6 months prior todiagnostic liver biopsy, except for GLP-1 agonists, which must remain on stabledose in the 6 months prior to diagnostic liver biopsy.
15. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks oftreatment (Visit 7). Initiation of any other antidiabetic drugs is allowed after Randomization based on treatingphysicians' judgment, except for glitazones which are prohibited 6 months prior todiagnostic liver biopsy until the end of treatment.

Exclusion Criteria:

1. Known heart failure (Grade I to IV of New York Heart Association classification).
2. History of efficient bariatric surgery within 5 years prior to screening.
3. Uncontrolled hypertension during the Screening Period despite optimal antihypertensivetherapy
4. Type 1 diabetes participants .
5. Participants with decompensated diabetes (HbA1c>9%).
6. Participants with a history of clinically significant acute cardiac event within 6months prior to screening
7. Weight loss of more than 5% within 6 months prior to randomization
8. Compensated and decompensated cirrhosis
9. Current or recent history (<5 years) of significant alcohol consumption
10. Pregnant or lactating females or females planning to become pregnant during the studyperiod.
11. Other well documented causes of chronic liver disease according to standard diagnosticprocedures
12. Participants with previous exposure to Elafibranor
13. Prohibited concomitant medication
14. Any medical conditions that may diminish life expectancy to less than 2 yearsincluding known cancers.
15. Evidence of any other unstable or untreated clinically significant immunological,endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatricdisease.
16. Mental instability or incompetence, such that the validity of informed consent orability to be compliant with the study is uncertain.
17. Participants with biological criteria exclusion as per effective protocol