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

Primary Purpose

Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Elafibranor

Placebo

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) With Fibrosis focused on measuring Elafibranor, NASH, Nonalcoholic steatohepatitis, Fatty liver disease, Fibrosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:
1. Cessation of menses for at least 12 months due to ovarian failure,
2. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
3. 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)
4. Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
5. 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:
1. 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.
2. 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.

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 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

Sites / Locations

University of Alabama at Birmingham
Digestive Health Specialists of the Southeast
The Institute for Liver Health
The Institute for Liver Health
Banner University Medical Center Phoenix
Dignity Health St. Joseph's Hospital
Mayo Clinic Hospital
Institute for Liver Health
Adobe Clinical Research, LLC
The University of Arizona College of Medicine Liver Research Institute
Liver Wellness Center
GW Research, Inc.
Southern California Research Center
University of California, San Francisco, Fresno Community Regional Medical Center
Fresno Clinical Research Center
University of California, San Francisco, Fresno Community Regional Medical Center
Scripps Clinic Torrey Pines
University of California - San Diego
Loma Linda University Medical Center - Transplantation Insitute
VA Long Beach Healthcare System
Keck Hospital of USC
Ruane Clinical Research Group Inc.
Cedars Sinai Medical Center
Gastrointestinal Biosciences Clinical Trials LLC
Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center
Veterans Affairs Greater Los Angeles Healthcare System
Alliance Clinical Research
National Research Institute
Alliance Clinical Research
University of California, Davis Medical Center
University of California, San Diego Airway Research and Clinical Trials Center
Medical Associates Research Group, Inc.
VA San Diego HealthCare System
Quest Clinical Research
Sutter West Bay Hospitals dba California Pacific Medical Center
University of California, San Francisco, Medical Center at Parnassus
Ventura Clinical Trials
South Denver Gastroenterology
Yale University School of Medicine, Section of Digestive Diseases
Georgetown University Hospitals
Sibley Memorial Hospital
Excel Medical Clinical Trials LLC
Integrity Clinical Research LLC
University of Florida
Nature Coast Clinical Research
Mayo Clinic Hospital
Florida Digestive Health Specialists, LLP
Atlantic Gastroenterology Associates, LLC
Miami VA Healthcare System
University of Miami - Miller School of Medicine
University of Miami - Schiff Center for Liver Diseases
South Florida Center of Gastroenterology, PA
Florida Medical Clinic, PA
Summit Clinical Research
Emory University Hospital Midtown
Piedmont Atlanta Hospital
Atlanta Medical Center, Inc.
Gastrointestinal Specialists of Georgia, PC
The Queen's Medical Center
Northwestern Memorial Hospital - Arkes Family Pavilion
Rush University Medical Center
The University of Chicago Medical Center
University of Chicago
Loyola University Chicago
Gastroenterology Associates of Hazard
University of Kentucky Chandler Medical Center
University of Louisville Medical / Dental Complex
Tulane University School of Medicine
Louisiana Research Center, LLC
Johns Hopkins Hospital
Walter Reed National Military Medical Center
Kaiser Permanente Shady Grove Medical Center
Tufts Medical Center
Massachusetts General Hospital
Beth Israel Deaconess Medical Center (BIDMC)
University of Massachusetts Memorial Medical Center
Henry Ford Health System, Division of Gastroenterology & Hepatology
Gastrointestinal Associates & Endoscopy Center
University of Mississippi Medical Center
St. Luke's Liver Transplant & Specialist
Kansas City VA Medical Center
Kansas City Research Institute
Saint Louis University School of Medicine
Rutgers, Robert Wood Johnson Medical School
Rutgers, New Jersey Medical School
Southwest Gastroenterology Associates
Montefiore Medical Center
University at Buffalo, Clinical and Translational Research Center
Hofstra Northwell School of Medicine
Concorde Medical Group
New York University Langone Medical Center
Weill Medical College of Cornell University
Icahn School of Medicine at Mount Sinai
New York-Presbyterian Hospital - Columbia University Medical Center
Beth Israel Medical Center
Premier Medical Group
Asheville Gastroenterology Associates
UNC Health Care System
Carolinas Medical Center
Duke Gastroenterology
Cumberland Research Associates, LLC
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
Diabetes & Endocrinology Consultants
Wake Research Associates
Piedmont Healthcare
Trial Management Associates
Consultants for Clinical Research
Ohio Gastroenterology & Liver Institute
University of Cincinnati Physicians Company , LLC
University Hospitals Cleveland Medical Center
The Ohio State University Wexner Medical Center
Options Health Research, LLC
Drexel University, College of Medicine
Thomas Jefferson University
Temple University Health System
Albert Einstein Medical Center
UPMC Montefiore
Rhode Island Hospital
Ralph H. Johnson VA Medical Center
Medical University of South Carolina (MUSC)
Medical University of South Carolina
Associates in Gastroenterology, PLC
Methodist University Hospital
Quality Medical Research, PLLC
Texas Clinical Research Institute
Methodist Dallas Medical Center
Liver Center of Texas
Baylor All Saints Medical Center - Baylor Research Institute
DHAT Research Institute
Baylor College of Medicine
Liver Associates of Texas, P.A.
Research Specialists of Texas
Centex Studies Inc.
Gulf Coast Research Group LLC
Brooke Army Medical Center
Gastroenterology Consultants of San Antonio
Centex Studies Inc
Pinnacle Clinical Research, PLLC
The Texas Liver Institute, Inc.
Pinnacle Clinical Research, PLLC
Texas Digestive Consultants (TDDC)
Victoria Gastroenterology
University of Utah School of Medicine
University of Virginia Health System
University of Virginia
Inova Fairfax Medical Campus - Center for Liver Disease
Bon Secours Liver Institute of Virginia - Newport News
Bon Secours Liver Institute of Virginia - Richmond
Hunter Holmes McGuire VA Medical Center
Virginia Commonwealth University
Kaiser Permanente Springfield Medical Center
Harborview Medical Center
Swedish Organ Transplant and Liver Center
Sanatorio Güemes
Axismed S.R.L
Instituto de Investigaciones Clinicas San Nicolas SRL
Hospital Alemán
Centro de Investigación y Prevención Cardiovascular SA (CIPREC)
Fundación Sanatorio Güemes
Hospital Italiano de Buenos Aires
Hospital Británico de Buenos Aires
CCBR Clinical Research
Centro De Hepatologia Ciudad de La Plata
Hospital Universitario Austral
Dim Clinica Privada
Hospital Provincial del Centenario
Instituto Medico Alas
Flinders Medical Centre
Box Hill Hospital
Monash Medical Centre Clayton
Concord Repatriation General Hospital
St. Vincent's Hospital Melbourne
Austin Hospital
Nepean Hospital
The St George Hospital
The Alfred Hospital
Fiona Stanley Hospital
Sir Charles Gairdner Hospital (SCGH)
Westmead Hospital
Hôpital Erasme
Universitair Ziekenhuis Brussel
Cliniques Universitaires Saint-Luc
Universitair Ziekenhuis Antwerpen
Universitair Ziekenhuis Gent
Universitair Ziekenhuis Leuven
Centre Hospitalier de Wallonie Picardie (CHWAPI)
LAIR Centre
Vancouver General Hospital (VGH) - Gordon and Leslie Diamond Health Care Centre
Toronto General Hospital
Toronto Western Hospital
Toronto Liver Centre
Monteregie Centre de Recherche
The Montreal Chest Institute
University of Calgary, Cumming School of Medicine
Queen Elizabeth II Health Sciences Centre, Nova Scotia Health Authority
Mc Gill University Health Centre (MUHC)
University of Manitoba
Hospital de La Serena
Alta Salud
Hospital Clínico UC
Hospital Clínico Universidad de Chile
Centro de Estudios Clinicos Barros Luco SPA (Patients seen, Fibroscan stored and Drug Shipment)
Clínica Reñaca
Solano&Terront Servicios Médicos LTDA - Unidad Integral de Endocrinologia UNIENDO
Fundación Cardio Infantil - Instituto de Cardiología
Fundación Valle del Lili
Centro Medico Imbanaco
Hospital Universitario San Vicente de Paul Fundación
Hospital Pablo Tobon Uribe
Fundacion Hospitalaria San Vicente de Paul
Fakultní Nemocnice Brno
Research Site S.R.O.
Research Site, s.r.o
KlinMed s.r.o.
Aarhus University Hospital
Helsinki University Central Hospital
CHU Amiens Picardie
CHU Angers
Hôpital Antoine-Béclère
Hôpital Beaujon
Hôpital Henri Mondor
CHU Limoges - Hôpital Dupuytren
Hôpital de la Croix-Rousse
Hôpital Saint Joseph
CHRU Montpellier- Hôpital Saint Eloi
CHU de Nantes - Hôpital Laennec
CHU de Nice- Hôpital de l'Archet II
Hôpital Saint-Antoine
Hopital Pitie-Salpetriere
Hôpital Cochin
Hôpital Haut-Lévêque
CHU Toulouse - Hôpital Purpan
CHU Nancy - Hôpital Brabois
Hôpital Paul Brousse
Universitätsklinikum Köln
Universitätsklinikum RWTH Aachen
Liver Center
Gastroenterologie am Bayerischen Platz/ Gastro-Studien
Universitätsklinikum Bonn
Universitätsklinikum Essen
Universitätsklinikum Frankfurt - Goethe Universität
Universitätsklinikum Freiburg
Asklepios Klinik St. Georg
Universitätsklinikum Hamburg-Eppendorf (UKE)
Medizinische Hochschule Hannover (MHH)
Universitätsklinikum Heidelberg
Universitätsklinikum Köln
EUGASTRO GmbH
Universitätsklinikum Leipzig
Universitätsklinikum Magdeburg
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Universitätsklinikum Würzburg
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Policlinico Tor Vergata
Fondazione Policlinico Universitario Agostino Gemelli
Ospedale Casa Sollievo della Sofferenza I.R.C.C.S.
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette
Hospital Angeles Clinica Londres
Centro de Investigación Clínica del Pacífico, S.A de C.V.
Hospital Maria Auxiliadora
Médica Sur
Consultorio Medico
Accelerium S de RL de C.V.
Vrije Universiteit Medical Center
Academisch Medisch Centrum
Maastricht UMC+
Radboud UMC
Centro Hospitalar e Universitário de Coimbra, EPE - Hospitais da Universidade de Coimbra
Centro Hospitalar Lisboa Central, EPE - Hospital Santo António dos Capuchos
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Centro Hospitalar de São João, EPE - Hospital de São João
Centro Hospitalar de São João
Centro Hospita de Tras-os-Montes e Alto Douro, EPE
Caparra Internal Medicine Research Center
Klinical Investigations Group, LLC
Fundacion de Investigacion de Diego
Fundación de Investigación
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Institutul Clinic Fundeni
SC Cabinet Particular Policlinic Algomed SRL
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu" Timisoara
FSBRI "Federal Research Center of nutrition and biotechnology
I. M. Sechenov - First Moscow State Medical University
M. F. Vladimirsky - Clinical Research Institution of Moscow Region
Military medical academy n. a. S.M. Kirov
St Petersburg State Budgetary Healthcare Institution City Clinical Hospital N°31
City Clinical Hospital No. 31
Tiervlei Trial Centre
Mediclinic Constantiaberg
Phoenix Pharma (Pty) Ltd
Hospital de la Santa Creu i Sant Pau
Hospital Universitario Vall d'Hebron
Hospital Clinic i Provincial
Hospital Universitario 12 de Octubre
Hospital Universitario Puerta de Hierro
Hospital Universitario Virgen de la Victoria
Complexo Hospitalario Universitario de Pontevedra
Hospital Universitario Marqués de Valdecilla
Campus Hospital Universitario Virgen del Rocío - Instituto de Biomedicina de Sevilla (IBIS)
Karolinska Universitetssjukhuset Huddinge
INSELSPITAL, University Hospital Bern
Centre Hospitalier Universitaire Vaudois (CHUV)
Kantonsspital St. Gallen
UniversitätsSpital Zürich
Ankara Üniversitesi Tıp Fakültesi
Bezmiâlem Vakıf Üniversitesi
Sağlık Bilimleri Üniversitesi Ümraniye Eğitim ve Araştırma Hastanesi
Ege Üniversitesi
Marmara Üniversitesi Eğitim ve Araştırma Hastanesi
Istanbul Universitesi Istanbul Tip Fakultesi
University Hospitals Birmingham NHS foundation Trust
Addenbrooke's Hospital
Frimley Park Hospital NHS Foundation Trust
Hull and East Yorkshire Hospitals NHS Trust - Hull Royal Infirmary
Bart Health NHS Trust- Royal London Hospital
The Royal Free London NHS Foundation Trust - The Royal Free Hospital
Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital
St George's University Hospitals NHS Foundation Trust - St George's Hospital
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital
Nottingham University Hospitals NHS FoundationTrust - Queen's Medical Centre
Plymouth Hospitals NHS Trust - Derriford Hospital
Portsmouth Hospitals NHS Trust - Queen Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

120 mg Elafibranor

Placebo

Arm Description

Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water

Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Outcomes

Primary Outcome Measures

Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.

Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes

Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.

Secondary Outcome Measures

Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage

To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants

Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.

Full Information

NCT ID

NCT02704403

First Posted

February 16, 2016

Last Updated

February 25, 2022

Sponsor

Genfit

1. Study Identification

Unique Protocol Identification Number

NCT02704403

Brief Title

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

Acronym

RESOLVE-IT

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Terminated

Why Stopped

Study did not meet the predefined primary surrogate efficacy endpoint, no safety issues identified

Study Start Date

March 2016 (undefined)

Primary Completion Date

October 28, 2020 (Actual)

Study Completion Date

October 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genfit

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Keywords

Elafibranor, NASH, Nonalcoholic steatohepatitis, Fatty liver disease, Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2157 (Actual)

8. Arms, Groups, and Interventions

Arm Title

120 mg Elafibranor

Arm Type

Experimental

Arm Description

Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water

Intervention Type

Drug

Intervention Name(s)

Elafibranor

Other Intervention Name(s)

GFT505

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis

Description

Time Frame

Measurement at 72 weeks

Title

Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes

Description

Time Frame

From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)

Secondary Outcome Measure Information:

Title

Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage

Description

Time Frame

Measurements at 72 weeks

Title

Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo

Description

Time Frame