ClinicalTrials.gov record
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
ClinicalTrials.gov ID: NCT02548351
Public ClinicalTrials.gov record NCT02548351. 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 Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects With Nonalcoholic Steatohepatitis
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 Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Study identification
- NCT ID
- NCT02548351
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,477 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 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
- Sep 22, 2015 (Actual)
- Primary completion
- Sep 15, 2023 (Actual)
- Completion
- Sep 15, 2023 (Actual)
- Last update posted
- Oct 1, 2024
2015 – 2023
United States locations
- U.S. sites
- 175
- U.S. states
- 39
- U.S. cities
- 119
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Digestive Health Specialists of the Southeast | Dothan | Alabama | 36305 | — |
| Institute for Liver Health DBA Arizona Liver Health | Chandler | Arizona | 85224 | — |
| Arizona Liver Health - Glendale | Glendale | Arizona | 85306 | — |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Arizona Liver Clinic - Tucson | Tucson | Arizona | 85711 | — |
| Liver Wellness Center | Little Rock | Arkansas | 72205 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| GW Research Inc. | Chula Vista | California | 91910 | — |
| Precision Research Institute | Chula Vista | California | 91910 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| Citrus Valley Gastroenterology | Covina | California | 91722 | — |
| TriWest Research Associates, LLC | El Cajon | California | 92020 | — |
| UCSF Fresno, Clinical Research Center | Fresno | California | 93701 | — |
| Fresno Clinical Research Center | Fresno | California | 93720 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| University of California, San Diego | La Jolla | California | 92037 | — |
| Keck Medical Center of USC | Los Angeles | California | 90033 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | — |
| National Research Institute, Wilshire | Los Angeles | California | 90057 | — |
| Gastrointestinal Biosciences | Los Angeles | California | 90067 | — |
| Veteran Affairs Great Los Angeles Healthcare System | Los Angeles | California | 90073 | — |
| Stanford University | Palo Alto | California | 94304 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of California Davis Medical Center | Sacramento | California | 95817 | — |
| eStudy Site | San Diego | California | 92120 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| Kaiser Permanente | San Diego | California | 92154 | — |
| California Pacific Medical Center (CPMC) | San Francisco | California | 94109 | — |
| UCSF/ San Francisco General Hospital | San Francisco | California | 94110 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| University of California, San Francisco | San Francisco | California | 94143 | — |
| Silicon Valley Research Institute | San Jose | California | 95128 | — |
| University of Colorado Denver and Hospital | Aurora | Colorado | 80045 | — |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | — |
| Western States Clinical Research, Inc. | Wheat Ridge | Colorado | 80033 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | — |
| Integrity Clinical Research, LLC | Doral | Florida | 33166 | — |
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| UF Health Jacksonville-Gastroenterology Emerson | Jacksonville | Florida | 32207 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Florida Digestive Health Specialist Research Institute | Lakewood Rch | Florida | 34211 | — |
| Sunrise Medical Research, Inc. | Lauderdale Lakes | Florida | 33319 | — |
| Meridien Research | Maitland | Florida | 32751 | — |
| Bruce W. Carter Miami VA Medical Center | Miami | Florida | 33125 | — |
| Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| ProLive Medical Research | Miami | Florida | 33175 | — |
| Janus Clinical Research, Inc. | Miami | Florida | 33186 | — |
| Sensible Healthcare, LLC | Ocoee | Florida | 34761 | — |
| Florida Hospital Transplant Institute | Orlando | Florida | 32804 | — |
| South Florida Center of Gastroenterology, P.A. | Wellington | Florida | 33414 | — |
| Florida Medical Clinic, P.A. | Zephyrhills | Florida | 33542 | — |
| Summit Clinical Research, LLC | Athens | Georgia | 30607 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| The Emory Clinic (TEC) | Atlanta | Georgia | 30322 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| The Queen's Medical Center - Liver Center | Honolulu | Hawaii | 96813 | — |
| Grand Teton Research Group | Idaho Falls | Idaho | 83404 | — |
| Northwestern University, Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Indiana University Health University Hospital | Indianapolis | Indiana | 46202 | — |
| Indianapolis Gastroenterology & Hepatology | Indianapolis | Indiana | 46237 | — |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| The Medical Center of Bowling Green | Bowling Green | Kentucky | 42101 | — |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40536 | — |
| University of Louisville Medical, Clinical Trials Unit | Louisville | Kentucky | 40202 | — |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Investigative Clinical Research | Annapolis | Maryland | 21401 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | 01805 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Gastroenterology Associates of Western Michigan, d.b.a West Michigan Clinical Research | Wyoming | Michigan | 49519 | — |
| Huron Gastroenterology Associates/Center for Digestive Care | Ypsilanti | Michigan | 48197 | — |
| Minnesota Gastroenterology | Minneapolis | Minnesota | 55413 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Southern Therapy and Advanced Research, LLC | Jackson | Mississippi | 39216 | — |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Saint Louis University Gastroenterology & Hepatology | St Louis | Missouri | 63104 | — |
| Washington University School of Medicine - Gastroenterology | St Louis | Missouri | 63110 | — |
| CHI Health Alegent Creighton Clinic Gastroenterology | Omaha | Nebraska | 68124 | — |
| AGA Clinical Research Associates, LLC | Egg Harbor | New Jersey | 08234 | — |
| Amici Clinical Research | Martinsville | New Jersey | 08836 | — |
| Amici GI - LLC | Martinsville | New Jersey | 08836 | — |
| Rutgers University New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | — |
| AccumetRx Clinical research / UGNM | Albuquerque | New Mexico | 87109 | — |
| University at Buffalo, Clinical and Translational Research Center | Buffalo | New York | 14203 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Concorde Medical Group PLLC | New York | New York | 10016 | — |
| New York University (NYU) Langone Medical Center | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Icahn School of Medicine at Mt. Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill, School of Medicine | Chapel Hill | North Carolina | 27599-7584 | — |
| Center for Liver Disease | Charlotte | North Carolina | 28204 | — |
| Charlotte Gastroenterology & Hepatology | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | — |
| Carolinas Center for Liver Disease/Carolinas HeatlhCare System | Huntersville | North Carolina | 28078 | — |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | — |
| Consultants for Clinical Research | Cincinnati | Ohio | 45249 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267-0595 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43203 | — |
| INTEGRIS Baptist Medical Center | Oklahoma City | Oklahoma | 73112 | — |
| Doylestown Health Gastroenterology | Doylestown | Pennsylvania | 18901 | — |
| Hillmont GI, pc | Flourtown | Pennsylvania | 19031 | — |
| The Pennsylvania State University and The Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hillmont G.I. - Lansdale Office | Lansdale | Pennsylvania | 19446 | — |
| Drexel University | Philadelphia | Pennsylvania | 19102 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Einstein Healthcare Network | Philadelphia | Pennsylvania | 19141 | — |
| UPMC | Pittsburgh | Pennsylvania | 15213 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Prisma Health- Upstate Gastroenterology and Liver Center | Greenville | South Carolina | 29605 | — |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | — |
| WR-Clinsearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Associates in Gastroenterology, PLC | Hermitage | Tennessee | 37076 | — |
| Clinical Research Solutions | Jackson | Tennessee | 38305 | — |
| East Tennesse Research Institute | Johnson City | Tennessee | 37604 | — |
| Methodist Healthcare, University Hospital | Memphis | Tennessee | 38104 | — |
| Nashville Gastrointestinal Specialists | Nashville | Tennessee | 37205 | — |
| Quality Medical Research, PLLC | Nashville | Tennessee | 37211 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| Liver Center of Texas | Dallas | Texas | 75234 | — |
| Texas Digestive Disease Consultants | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| MedResearch, Inc. | El Paso | Texas | 79935 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Baylor Scott & White All Saints Medical Center | Fort Worth | Texas | 76104 | — |
| Texas Digestive Disease Consultants | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine Ben Taub General Hospital | Houston | Texas | 77030 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| The University of Texas Health Science Center at Houston-Medical School IM-Division of Gastroenterology, Hepatology & Nutrition | Houston | Texas | 77030 | — |
| Centex Studies, Inc. | Houston | Texas | 77058 | — |
| Centex Studies, Inc. | McAllen | Texas | 78504 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Gastroenterology Consultants of San Antonio | San Antonio | Texas | 78229 | — |
| Texas Digestive Disease Consultants - San Marcos | San Marcos | Texas | 78666 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| The University of Vermont Medical Center - Smith 2 | Burlington | Vermont | 05401 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Bon Secours St. Mary's Hospital | Richmond | Virginia | 23226 | — |
| McGuire DVAMC GI | Richmond | Virginia | 23249 | — |
| Virginia Commonwealth University Clinical Research Services Unit (CRSU) | Richmond | Virginia | 23298 | — |
| Virginia Mason - Seattle Medical Center | Seattle | Washington | 98101 | — |
| Swedish Organ Transplant and Liver Center | Seattle | Washington | 98104 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| University of Wisconsin Hospital & Clinics | Madison | Wisconsin | 53705 | — |
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 171 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02548351, 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 Oct 1, 2024 · 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 NCT02548351 live on ClinicalTrials.gov.