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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis (NASH) With Fibrosis

In brief

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.

Key facts

Study ID

NCT02704403

Run by

Genfit

People needed

2157

Starts

2016-03-01

Expected to finish

2020-10-28

Last updated by the study team

2022-03-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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:
• Cessation of menses for at least 12 months due to ovarian failure,
• Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
• 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)
• Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
• 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.
• 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
• 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:
• 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.
• 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 may not qualify if…

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

Where it is running

• Digestive Health Specialists of the Southeast — Dothan, Alabama, United States
• The Institute for Liver Health — Chandler, Arizona, United States
• The Institute for Liver Health — Glendale, Arizona, United States
• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• Dignity Health St. Joseph's Hospital — Phoenix, Arizona, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Institute for Liver Health — Tucson, Arizona, United States
• Adobe Clinical Research, LLC — Tucson, Arizona, United States
• The University of Arizona College of Medicine Liver Research Institute — Tucson, Arizona, United States
• Liver Wellness Center — Little Rock, Arkansas, United States
• GW Research, Inc. — Chula Vista, California, United States
• Southern California Research Center — Coronado, California, United States
• University of California, San Francisco, Fresno Community Regional Medical Center — Fresno, California, United States
• Fresno Clinical Research Center — Fresno, California, United States
• University of California, San Francisco, Fresno Community Regional Medical Center — Fresno, California, United States
• Scripps Clinic Torrey Pines — La Jolla, California, United States
• University of California - San Diego — La Jolla, California, United States
• Loma Linda University Medical Center - Transplantation Insitute — Loma Linda, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Keck Hospital of USC — Los Angeles, California, United States
• Ruane Clinical Research Group Inc. — Los Angeles, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Gastrointestinal Biosciences Clinical Trials LLC — Los Angeles, California, United States
• Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center — Los Angeles, California, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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