ClinicalTrials.gov record
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT04971785
Public ClinicalTrials.gov record NCT04971785. 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, Double-Dummy, Placebo-Controlled Study Evaluating the Safety and Efficacy of Semaglutide, and the Fixed-Dose Combination of Cilofexor and Firsocostat, Alone and in Combination, in Subjects With Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The goal of this clinical study is to understand whether the study drugs, semaglutide (SEMA) with the fixed-dose combination (FDC) of cilofexor/firsocostat (CILO/FIR), cause fibrosis improvement and Nonalcoholic Steatohepatitis (NASH) resolution in participants with cirrhosis due to NASH.
Study identification
- NCT ID
- NCT04971785
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 457 participants
Conditions and interventions
Conditions
Interventions
- Semaglutide (SEMA) Drug
- Cilofexor (CILO)/Firsocostat (FIR) Drug
- PTM SEMA Drug
- PTM CILO/FIR 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
- Aug 9, 2021 (Actual)
- Primary completion
- Nov 12, 2024 (Actual)
- Completion
- Dec 9, 2024 (Actual)
- Last update posted
- Nov 26, 2025
2021 – 2024
United States locations
- U.S. sites
- 175
- U.S. states
- 35
- U.S. cities
- 140
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Hospital | Birmingham | Alabama | 35233 | — |
| Digestive Health Specialists | Dothan | Alabama | 36305 | — |
| North Alabama Health Research, LLC | Madison | Alabama | 35758 | — |
| The Institution For Liver Health dba Arizona Liver Health | Chandler | Arizona | 85224 | — |
| Arizona Health Research | Chandler | Arizona | 85225 | — |
| The Institute for Liver Health DBA Arizona Liver Health | Peoria | Arizona | 85381 | — |
| Gastrointestinal Alliance - Sun City | Sun City | Arizona | 85351 | — |
| Adobe Clinical Research, LLC | Tucson | Arizona | 85712 | — |
| The Institution For Liver Health dba Arizona Liver Health | Tucson | Arizona | 85712 | — |
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72204 | — |
| ARCare Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| Southern California Research Center | Coronado | California | 92118 | — |
| University of California, San Francisco - Fresno | Fresno | California | 93701 | — |
| University of California, San Diego - Altman Clinical and Translational Research Institute | La Jolla | California | 92037 | — |
| Gastro Care Institute (Fibroscan) | Lancaster | California | 93534 | — |
| Digestive Health Research of Southern California | Long Beach | California | 90808 | — |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| Keck Medical Center of USC Healthcare Consultation II | Los Angeles | California | 90033 | — |
| Biopharma Informatic, LLC | Los Angeles | California | 90035 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| Knowledge Research Center | Orange | California | 92868 | — |
| Palmtree Clinical Research, Inc. | Palm Springs | California | 92262 | — |
| California Liver Research Institute | Pasadena | California | 91105 | — |
| Cadena Care Institute, LLC | Poway | California | 92064 | — |
| Stanford Medicine Outpatient Center | Redwood City | California | 94063 | — |
| Inland Empire Clinical Trials | Rialto | California | 92377 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| Research and Education Inc. | San Diego | California | 92105 | — |
| TriWest Research Associates, LLC | San Diego | California | 92108 | — |
| Precision Research Institute | San Diego | California | 92114 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| University of California, San Francisco - Liver Clinic | San Francisco | California | 94143 | — |
| San Jose Gastroenterology at One Health | San Jose | California | 95128 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | — |
| Yale Center for Clinical Investigation, Church Street Research Unit | New Haven | Connecticut | 06519 | — |
| Excel Medical Clinical Trials, LLC | Boca Raton | Florida | 33434 | — |
| Synergy Healthcare | Bradenton | Florida | 34208 | — |
| Southwest General Healthcare Center | Fort Myers | Florida | 33907 | — |
| University of Florida Hepatology Research at the Clinical and Translational Research Building | Gainesville | Florida | 32610 | — |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | — |
| Indago Research and Health Center, Inc. | Hialeah | Florida | 33012 | — |
| Maya Research Center | Hialeah | Florida | 33016 | — |
| New Generation of Medical Research | Hialeah | Florida | 33016 | — |
| Evolution Clinical Research, INC | Hialeah Gardens | Florida | 33016 | — |
| Sunbright Health Medical Center | Homestead | Florida | 33032 | — |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | — |
| UF Health Jacksonville-Gastroenterology Emerson | Jacksonville | Florida | 32224 | — |
| Encore Borland-Groover Clinical Research | Jacksonville | Florida | 32256 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| G+C Research Group | Miami | Florida | 33126 | — |
| Schiff Center for Liver Diseases/ University of Miami | Miami | Florida | 33136 | — |
| Advanced Pharma CR, LLC | Miami | Florida | 33147 | — |
| Century Research, LLC | Miami | Florida | 33173 | — |
| ProLive Medical Research, Corp | Miami | Florida | 33175 | — |
| International Medical Investigational Centers, Inc. | Miami | Florida | 33176 | — |
| Ocean Blue Medical Research Center, Inc | Miami Springs | Florida | 33166 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | — |
| Ocala GI Research | Ocala | Florida | 34471 | — |
| Advanced Medical Research Center | Port Orange | Florida | 32127 | — |
| Progressive Medical Research | Port Orange | Florida | 32127 | — |
| Covenant Metabolic Specialists, LLC | Sarasota | Florida | 34240 | — |
| Charter Research | Winter Park | Florida | 32792 | — |
| Florida Medical Clinic, LLC | Zephyrhills | Florida | 33542 | — |
| Southeast Clinical Research LLC | Dalton | Georgia | 30720 | — |
| Gastrointestinal (GI) Specialists of Georgia | Marietta | Georgia | 30060 | — |
| Rush University Medical Group - Department of Hepatology | Chicago | Illinois | 60612 | — |
| Indiana University Health Enterprise Clinical Research Operations | Indianapolis | Indiana | 46202 | — |
| Gastroenterology Health Partners, PLLC | New Albany | Indiana | 47150 | — |
| Digestive Research Alliance of Michigan | South Bend | Indiana | 44635 | — |
| Iowa Digestive Disease Center, PC | Clive | Iowa | 50325 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Kansas Medical Clinic PA | Topeka | Kansas | 66606 | — |
| GI Alliance | Baton Rouge | Louisiana | 70809 | — |
| Combined Gastro Research, LLC | Lafayette | Louisiana | 70503 | — |
| Tandem Clinical Research GI, LLC | Marrero | Louisiana | 70072 | — |
| Delta Research Partners | Monroe | Louisiana | 71201 | — |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | — |
| Oschner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | 71105 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | 21061 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Greater Boston Gastroenterology | Framingham | Massachusetts | 01702 | — |
| Hawthorn Medical Associates | South Dartmouth | Massachusetts | 02747 | — |
| Michigan Medicine - University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | 48047 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center | Wyoming | Michigan | 49519 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| GI Alliance | Flowood | Mississippi | 39232 | — |
| Southern Therapy and Advanced Research | Jackson | Mississippi | 39216 | — |
| Clinical Research Professionals | Chesterfield | Missouri | 63005 | — |
| GI Associates Research | Columbia | Missouri | 65201 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | — |
| Digestive Disease Research | Florham Park | New Jersey | 07932 | — |
| Allied Health Clinical Research Organization, LLC | Freehold | New Jersey | 07728 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Center for Research at Southwest Gastroenterology Associates, PC | Albuquerque | New Mexico | 87109 | — |
| Northwell Health Center for Liver Diseases | Manhasset | New York | 11030 | — |
| New York University Langone Health | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Liver Clinic (study visits, Fibroscan): Columbia University Irving Medical Center / NewYork Presbyterian Hospital | New York | New York | 10032 | — |
| The New York - Presbyterian Hospital | New York | New York | 10065 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Asheville Gastroenterology, a Division of Digestive Health Partners, PA | Asheville | North Carolina | 28801 | — |
| Atrium Health Transplant and Center for Liver Disease | Charlotte | North Carolina | 28204 | — |
| Charlotte Gastroenterology & Hepatology, PLLC | Charlotte | North Carolina | 28207 | — |
| Northeast GI Research Division | Concord | North Carolina | 28027 | — |
| Coastal Research Institute | Fayetteville | North Carolina | 28304 | — |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | — |
| Carolina's GI Research, LLC | Raleigh | North Carolina | 27607 | — |
| Optimed Research | Columbus | Ohio | 43235 | — |
| DSI Research | Springboro | Ohio | 45066 | — |
| Clinical Research Institute of Ohio, LLC | Westlake | Ohio | 44145 | — |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| Velocity Clinical Research - Providence | East Greenwich | Rhode Island | 02818 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Columbia Digestive Health Research | Columbia | South Carolina | 29204 | — |
| Digestive Disease Research Center | Greenwood | South Carolina | 29646 | — |
| Velocity Clinical Research, Spartanburg | Spartanburg | South Carolina | 29303 | — |
| Wake Research - ClinsSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Gastrointestinal Associates of Northeast Tennessee | Johnson City | Tennessee | 37604 | — |
| Quality Medical Research, PLLC | Nashville | Tennessee | 37211 | — |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | — |
| Pinnacle Clinical Research | Austin | Texas | 78757 | — |
| South Texas Research Institute | Brownsville | Texas | 78520 | — |
| GI Alliance | Cedar Park | Texas | 78613 | — |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | — |
| GI Alliance | Dallas | Texas | 75246 | — |
| Internal Medicine Digestive and Liver Diseases Clinical Trials | Dallas | Texas | 75390 | — |
| Soma Clinical Trials, LLC | Denison | Texas | 75020 | — |
| DHR Health Institute for Research and Development Cancer Research Center | Edinburg | Texas | 78539 | — |
| South Texas Research Institute | Edinburg | Texas | 78539 | — |
| GI Alliance | Fort Worth | Texas | 76104 | — |
| GI Alliance | Garland | Texas | 75044 | — |
| Pinnacle Clinical Research | Georgetown | Texas | 78626 | — |
| Texas Digestive Specialists | Harlingen | Texas | 78550 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Liver Associates of Texas, P.A. | Houston | Texas | 77030 | — |
| Liver Specialists of Texas | Houston | Texas | 77030 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | — |
| Houston Research Institute | Houston | Texas | 77079 | — |
| Biopharma Informatic, LLC | Houston | Texas | 77084 | — |
| BioStar Clinical Research Group Inc. | Katy | Texas | 77494 | — |
| GI Alliance | Lubbock | Texas | 79410 | — |
| Biopharma Informatic, LLC | McAllen | Texas | 78503 | — |
| Digestive System Healthcare | Pasadena | Texas | 77505 | — |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Diabetes and Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | — |
| Pinnacle Clinical Research, LLC | San Antonio | Texas | 78229 | — |
| GI Alliance (Patients Seen, IP Shipment & Fibroscan) | San Marcos | Texas | 78666 | — |
| Impact Research Institute | Waco | Texas | 76710 | — |
| GI Alliance | Webster | Texas | 77598 | — |
| Digestive Health Research of North Texas | Wichita Falls | Texas | 07960 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Velocity Clinical Research, Salt Lake City | West Jordan | Utah | 84088 | — |
| The University Of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Manassas Clinical Research Center | Manassas | Virginia | 20110 | — |
| 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 | — |
| Virginia Commonwealth University Health Clinical Research Services Unit | Richmond | Virginia | 23298 | — |
| Virginia Mason | Seattle | Washington | 98101 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
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 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04971785, 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 Nov 26, 2025 · Synced Oct 28, 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 NCT04971785 live on ClinicalTrials.gov.