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
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
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.
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.
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:
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:
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.
Exclusion Criteria:
Tucson, Arizona 85724-0001, United States
Fresno, California 93701-2302, United States
Fresno, California 93721, United States
Loma Linda, California 92354, United States
Los Angeles, California 90073, United States
San Diego, California 92103, United States
San Francisco, California 94115, United States
San Francisco, California 94143, United States
New Haven, Connecticut 65200, United States
Detroit, Michigan 48202, United States
Buffalo, New York 14203, United States
New York, New York 10032, United States
Huntersville, North Carolina 28078, United States
Caba, Buenos Aires 1180AAX, Argentina
CABA, Buenos Aires C1430CKE, Argentina
San Nicolás de los Arroyos, Buenos Aires 2900, Argentina
Vancouver, British Columbia V5Z 1M9, Canada
Santiago, 8910108, Chile
Bogotá, Bogota D.C. 110221, Colombia
Torino, 10126, Italy
Coimbra, 3000-075, Portugal
Lisbon, 1169-050, Portugal
Saint Petersburg, 197110, Russia
Seville, 41014, Spain
Istanbul, 34766, Turkey (Türkiye)
London, SW170QT, United Kingdom
Newcastle upon Tyne, NE7 7DN, United Kingdom
Nottingham, NG7 2UH, United Kingdom