ClinicalTrials.gov record
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT02704403
Public ClinicalTrials.gov record NCT02704403. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02704403
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,157 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2016 (Type not available)
- Primary completion
- Oct 28, 2020 (Actual)
- Completion
- Oct 28, 2020 (Actual)
- Last update posted
- Mar 23, 2022
2016 – 2020
United States locations
- U.S. sites
- 153
- U.S. states
- 32
- U.S. cities
- 101
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| The Institute for Liver Health | Chandler | Arizona | 85224 | — |
| The Institute for Liver Health | Glendale | Arizona | 85306 | — |
| Banner University Medical Center Phoenix | Phoenix | Arizona | 85006 | — |
| Dignity Health St. Joseph's Hospital | Phoenix | Arizona | 85013 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Institute for Liver Health | Tucson | Arizona | 85711 | — |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | — |
| The University of Arizona College of Medicine Liver Research Institute | Tucson | Arizona | 85724-0001 | — |
| Liver Wellness Center | Little Rock | Arkansas | 72205 | — |
| GW Research, Inc. | Chula Vista | California | 91910 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| University of California, San Francisco, Fresno Community Regional Medical Center | Fresno | California | 93701-2302 | — |
| Fresno Clinical Research Center | Fresno | California | 93720 | — |
| University of California, San Francisco, Fresno Community Regional Medical Center | Fresno | California | 93721 | — |
| Scripps Clinic Torrey Pines | La Jolla | California | 92037 | — |
| University of California - San Diego | La Jolla | California | 92037 | — |
| Loma Linda University Medical Center - Transplantation Insitute | Loma Linda | California | 92354 | — |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | — |
| Keck Hospital of USC | Los Angeles | California | 90033 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | — |
| Gastrointestinal Biosciences Clinical Trials LLC | Los Angeles | California | 90067 | — |
| Veterans Affaires Greater Los Angeles Healthcare System, West LA VA Medical Center | Los Angeles | California | 90073 | — |
| Veterans Affairs Greater Los Angeles Healthcare System | Los Angeles | California | 90073 | — |
| Alliance Clinical Research | Oceanside | California | 92056 | — |
| National Research Institute | Panorama City | California | 91402 | — |
| Alliance Clinical Research | Poway | California | 92064 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| University of California, San Diego Airway Research and Clinical Trials Center | San Diego | California | 92103 | — |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | — |
| VA San Diego HealthCare System | San Diego | California | 92161 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Sutter West Bay Hospitals dba California Pacific Medical Center | San Francisco | California | 94115 | — |
| University of California, San Francisco, Medical Center at Parnassus | San Francisco | California | 94143 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | — |
| Yale University School of Medicine, Section of Digestive Diseases | New Haven | Connecticut | 65200 | — |
| Georgetown University Hospitals | Washington D.C. | District of Columbia | 20007 | — |
| Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | — |
| Integrity Clinical Research LLC | Doral | Florida | 33166 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| Mayo Clinic Hospital | Jacksonville | Florida | 32224 | — |
| Florida Digestive Health Specialists, LLP | Lakewood Rch | Florida | 34211-4930 | — |
| Atlantic Gastroenterology Associates, LLC | Lakewood Rch | Florida | 34211 | — |
| Miami VA Healthcare System | Miami | Florida | 33125-1624 | — |
| University of Miami - Miller School of Medicine | Miami | Florida | 33136 | — |
| University of Miami - Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| South Florida Center of Gastroenterology, PA | Wellington | Florida | 33414 | — |
| Florida Medical Clinic, PA | Zephyrhills | Florida | 33542 | — |
| Summit Clinical Research | Athens | Georgia | 30607 | — |
| Emory University Hospital Midtown | Atlanta | Georgia | 30308 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Atlanta Medical Center, Inc. | Atlanta | Georgia | 30312 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060-8949 | — |
| The Queen's Medical Center | Honolulu | Hawaii | 96813 | — |
| Northwestern Memorial Hospital - Arkes Family Pavilion | Chicago | Illinois | 60611 | — |
| Rush University Medical Center | Chicago | Illinois | 60637 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Loyola University Chicago | Maywood | Illinois | 60153 | — |
| Gastroenterology Associates of Hazard | Hazard | Kentucky | 41701 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| University of Louisville Medical / Dental Complex | Louisville | Kentucky | 40202 | — |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21205 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Kaiser Permanente Shady Grove Medical Center | Rockville | Maryland | 20850 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Beth Israel Deaconess Medical Center (BIDMC) | Boston | Massachusetts | 02215 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 06155 | — |
| Henry Ford Health System, Division of Gastroenterology & Hepatology | Detroit | Michigan | 48202 | — |
| Gastrointestinal Associates & Endoscopy Center | Flowood | Mississippi | 39232 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| St. Luke's Liver Transplant & Specialist | Kansas City | Missouri | 64111 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Saint Louis University School of Medicine | St Louis | Missouri | 63104 | — |
| Rutgers, Robert Wood Johnson Medical School | New Brunswick | New Jersey | 89030 | — |
| Rutgers, New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Southwest Gastroenterology Associates | Albuquerque | New Mexico | 87109 | — |
| University at Buffalo, Clinical and Translational Research Center | Buffalo | New York | 14203 | — |
| Hofstra Northwell School of Medicine | Manhasset | New York | 11030 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| New York University Langone Medical Center | New York | New York | 10016 | — |
| Weill Medical College of Cornell University | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| New York-Presbyterian Hospital - Columbia University Medical Center | New York | New York | 10032 | — |
| Beth Israel Medical Center | New York | New York | 45267 | — |
| Premier Medical Group | Poughkeepsie | New York | 12601 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Asheville Gastroenterology Associates | Asheville | North Carolina | 28801 | — |
| UNC Health Care System | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke Gastroenterology | Durham | North Carolina | 22710 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | — |
| Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health | Huntersville | North Carolina | 28078 | — |
| Diabetes & Endocrinology Consultants | Morehead City | North Carolina | 28557 | — |
| Wake Research Associates | Raleigh | North Carolina | 27612 | — |
| Piedmont Healthcare | Statesville | North Carolina | 28677 | — |
| Trial Management Associates | Wilmington | North Carolina | 28403 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | — |
| Ohio Gastroenterology & Liver Institute | Cincinnati | Ohio | 45249 | — |
| University of Cincinnati Physicians Company , LLC | Cincinnati | Ohio | 45267 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104-4017 | — |
| Drexel University, College of Medicine | Philadelphia | Pennsylvania | 19102 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Health System | Philadelphia | Pennsylvania | 19140 | — |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | — |
| UPMC Montefiore | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | — |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Associates in Gastroenterology, PLC | Hermitage | Tennessee | 37076 | — |
| Methodist University Hospital | Memphis | Tennessee | 38103 | — |
| Quality Medical Research, PLLC | Nashville | Tennessee | 37211 | — |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | — |
| Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Liver Center of Texas | Dallas | Texas | 75234 | — |
| Baylor All Saints Medical Center - Baylor Research Institute | Fort Worth | Texas | 76104 | — |
| DHAT Research Institute | Garland | Texas | 75044 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| Research Specialists of Texas | Houston | Texas | 77030 | — |
| Centex Studies Inc. | Houston | Texas | 77058 | — |
| Gulf Coast Research Group LLC | Houston | Texas | 77098 | — |
| Brooke Army Medical Center | Houston | Texas | 78234 | — |
| Gastroenterology Consultants of San Antonio | Live Oak | Texas | 78233 | — |
| Centex Studies Inc | McAllen | Texas | 78504 | — |
| Pinnacle Clinical Research, PLLC | Rollingwood | Texas | 78746 | — |
| The Texas Liver Institute, Inc. | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research, PLLC | San Antonio | Texas | 78229 | — |
| Texas Digestive Consultants (TDDC) | Southlake | Texas | 76092-9167 | — |
| Victoria Gastroenterology | Victoria | Texas | 77904 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Medical Campus - Center for Liver Disease | Falls Church | Virginia | 22042 | — |
| Bon Secours Liver Institute of Virginia - Newport News | Newport News | Virginia | 23602 | — |
| Bon Secours Liver Institute of Virginia - Richmond | Richmond | Virginia | 23226 | — |
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Kaiser Permanente Springfield Medical Center | Springfield | Virginia | 22150 | — |
| Harborview Medical Center | Seattle | Washington | 98104-2420 | — |
| Swedish Organ Transplant and Liver Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 173 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02704403, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 23, 2022 · Synced Nov 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02704403 live on ClinicalTrials.gov.