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

Overview

  • Study type

    Interventional
  • Study phase

    III
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 17-007325
    NCT ID: NCT02704403
    Sponsor Protocol Number: GFT505-315-1

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • Males or females aged from 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 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.
  • 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).
  • 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 patients.
  • Patients with decompensated diabetes (HbA1c>9%).
  • Patients with 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 females or females planning to become pregnant during the study period.
  • Other well documented causes of chronic liver disease according to standard diagnostic procedures.
  • Patients with 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Elizabeth Carey, M.D.

Open for enrollment

Contact information:

Isabel Santana

(480)342-2942

Santana.Isabel@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available