ClinicalTrials.gov record
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT03449446
Public ClinicalTrials.gov record NCT03449446. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib, GS-0976, GS-9674, and Combinations in Subjects With Bridging (F3) Fibrosis or Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are: * To assess the safety and tolerability of selonsertib (SEL), firsocostat (FIR) and cilofexor (CILO), administered alone or in combination, in participants with bridging fibrosis or compensated cirrhosis due to NASH * To evaluate changes in liver fibrosis, without worsening of NASH
Study identification
- NCT ID
- NCT03449446
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 395 participants
Conditions and interventions
Conditions
Interventions
- SEL Drug
- FIR Drug
- CILO Drug
- Placebo to match FIR Drug
- Placebo to match CILO Drug
- Placebo to match SEL Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 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 20, 2018
- Primary completion
- Oct 29, 2019
- Completion
- Nov 18, 2019
- Last update posted
- Dec 2, 2020
2018 – 2019
United States locations
- U.S. sites
- 81
- U.S. states
- 30
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Institute for Liver Health | Chandler | Arizona | 85224-5688 | — |
| Mayo Clinic Arizona, Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Liver Wellness Center | Little Rock | Arkansas | 72204 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| eStudySite | Chula Vista | California | 91911-6660 | — |
| Southern California Liver Center | Coronado | California | 92118 | — |
| Fresno Clinical Research Center | Fresno | California | 93720 | — |
| UCSD NAFLD Clinical Research Center | La Jolla | California | 92037 | — |
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | — |
| Cedars-Sinai Medical Center | Los Angeles | California | 99352 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| Huntington Medical Research Institutes Liver Center | Pasadena | California | 91105 | — |
| Inland Empire Liver Foundation | Rialto | California | 92377 | — |
| University of California, Davis Medical Center (study visits) | Sacramento | California | 95817 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | — |
| Integrity Clinical Research | Doral | Florida | 33166 | — |
| UF Hepatology Research at CTRB | Gainesville | Florida | 32610 | — |
| Schiff Center for Liver Diseases/University of Miami | Miami | Florida | 33136 | — |
| IMIC Inc | Miami | Florida | 33157 | — |
| Genoma Research Group | Miami | Florida | 33165 | — |
| Florida Research Institute | Tampa | Florida | 34211 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Gastrointestinal Diseases Research | Columbus | Georgia | 31904 | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Northwestern University; Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | — |
| Iowa Digestive Disease Center, P.C. | Clive | Iowa | 50325 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Delta Research Partners, LLC | Bastrop | Louisiana | 71220 | — |
| Tulane University | New Orleans | Louisiana | 70112 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Southern Therapy and Advanced Research (STAR) LLC | Ridgeland | Mississippi | 39157 | — |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Jubilee Clinical Research, Inc. | Las Vegas | Nevada | 89106 | — |
| Rutgers New Jersey Medical School- Doctors Office Center | Newark | New Jersey | 07103 | — |
| Sandra Atlas Bass Center for Liver Diseases and Transplantation | Manhasset | New York | 11030 | — |
| Icahn School of Medicine at Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Concorde Medical Group, PLLC | New York | New York | 10016 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Carolinas Healthcare System Center for Liver Disease and Transplant | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center, Duke South Clinics | Durham | North Carolina | 27710 | — |
| Cumberland Research Associates, LLC | Fayetteville | North Carolina | 28304 | — |
| Consultants for Clinical Research wed | Cincinnati | Ohio | 45249 | — |
| Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute | Pittsburgh | Pennsylvania | 15213 | — |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Medical University of South Carolina (Liver Biopsy) | Charleston | South Carolina | 29425 | — |
| GHS Gastroenterology and Liver Center | Greenville | South Carolina | 29605 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Quality Medical Research, PLLC | Nashville | Tennessee | 37211 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Pinnacle Clinical Research, PLLC | Austin | Texas | 78746 | — |
| Austin Center for Clinical Research | Austin | Texas | 78758 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| University of Texas Southwestern Medical Center Internal Medicine Digestive and Liver Diseases Clinical Trials | Dallas | Texas | 75390 | — |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Pinnacle Clinical Research | Live Oak | Texas | 78233 | — |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Intermountain Liver Disease and Transplant Center | Murray | Utah | 84107 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant | Falls Church | Virginia | 22042 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Bon Secours Richmond Community Hospital, Inc. d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| McGuire DVAMC | Richmond | Virginia | 23249 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| 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 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03449446, 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 Dec 2, 2020 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03449446 live on ClinicalTrials.gov.