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

a study on FibrosisSteatohepatitis

Summary

for people ages 18-75 (full criteria)
at Fresno, California and other locations
study started

Description

Summary

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.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis

Keywords

Nonalcoholic Steatohepatitis (NASH) With FibrosisElafibranorNASHNonalcoholic steatohepatitisFatty liver diseaseFibrosisFatty LiverNon-alcoholic Fatty Liver Disease

Eligibility

You can join if…

Open to people ages 18-75

  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

You CAN'T join if...

  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.

Locations

  • University of California, San Francisco, Fresno Community Regional Medical Centeraccepting new patients
    FresnoCalifornia93721United States
  • University of California, San Francisco, Medical Center at Parnassusaccepting new patients
    San FranciscoCalifornia94143United States
  • Quest Clinical Researchaccepting new patients
    San FranciscoCalifornia94115United States
  • Sutter West Bay Hospitals dba California Pacific Medical Centeraccepting new patients
    San FranciscoCalifornia94115United States
  • Fresno Clinical Research Centeraccepting new patients
    FresnoCalifornia93720United States

Details

Status
accepting new patients
Start Date
Sponsor
Genfit
ID
NCT02704403
Phase
Phase 3
Study Type
Interventional
Last Updated