Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
completion

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 Fibrosis Elafibranor NASH Nonalcoholic steatohepatitis Fatty liver disease Fibrosis Fatty Liver Non-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. Females participating in this study must be of nonchildbearing potential or using highly efficient contraception for the full duration of the study and for 1 month after 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 medically documented ovarian failure
  6. If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
  7. Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
  8. Double contraception with barrier AND highly effective hormonal method of contraception (oral, intravaginal, or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation; oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; or intrauterine hormone-releasing system). The hormonal contraception must be started at least 1 month prior to Randomization.
  9. 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).
  10. NAS score ≥4.
  11. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system.
  12. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at least 6 months prior to diagnostic liver biopsy
  13. For participants with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
  14. No qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for participants treated with metformin, gliptins, sulfonylureas, sodium/glucose cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or insulin. Dose changes of these medications are allowed in the 6 months prior to diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable dose in the 6 months prior to diagnostic liver biopsy.
  15. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (Visit 7).

Initiation of any other antidiabetic drugs is allowed after Randomization based on treating physicians' judgment, except for glitazones which are prohibited 6 months prior to diagnostic liver biopsy until the end of treatment.

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 during the Screening Period despite optimal antihypertensive therapy
  4. Type 1 diabetes participants .
  5. Participants with decompensated diabetes (HbA1c>9%).
  6. Participants 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. . Participants 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.
  17. . Participants with biological criteria exclusion as per effective protocol

Locations

  • University of California, Davis Medical Center
    Sacramento California 95817 United States
  • Quest Clinical Research
    San Francisco California 94115 United States
  • Sutter West Bay Hospitals dba California Pacific Medical Center
    San Francisco California 94115 United States

Details

Status
accepting new patients
Start Date
Completion Date
Sponsor
Genfit
Links
Sign up for this study
ID
NCT02704403
Phase
Phase 3 research study
Study Type
Interventional
Participants
At least 2157 people participating
Last Updated