Purpose

The primary objectives of this study are to evaluate the effect of Elafibranor treatment compared to placebo on 1) histological improvement and 2) all-cause mortality and liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 study protocol.
  3. BMI ≤45 kg/m².
  4. Females participating in the study must either not be of childbearing potential (hysterectomy, bilateral oophorectomy, medically documented ovarian failure, or >50 years of age with cessation of menses for at least 12 months due to ovarian failure) or using efficient double contraception: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device, or other mechanical contraception method + condom or diaphragm or spermicide for the full duration of the study and for 1 month after the end of treatment.
  5. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central reading of the slides (biopsy obtained within 6 months prior to randomization or during 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 inflammation scored 0-3).
  6. NAS score ≥4.
  7. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
  8. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
  9. No change in antidiabetic therapy within 6 months prior to liver biopsy

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
  4. Type 1 diabetes patients.
  5. Patients with decompensated diabetes (HbA1c>9%).
  6. Patients with a history of clinically significant acute cardiac event within 6 months 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 study period.
  11. Other well documented causes of chronic liver disease according to standard diagnostic procedures
  12. Patients with previous exposure to Elafibranor
  13. Prohibited concomitant medication
  14. Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
  15. Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease.
  16. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
120 mg Elafibranor
Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
  • Drug: Elafibranor
    Other names:
    • GFT505
Placebo Comparator
Placebo
Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
  • Drug: Placebo

Recruiting Locations

Banner University Medical Center Phoenix
Phoenix, Arizona 85006

More Details

NCT ID
NCT02704403
Status
Recruiting
Sponsor
Genfit

Study Contact

GENFIT
clinicaltrial@genfit.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.