ClinicalTrials.gov record
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
ClinicalTrials.gov ID: NCT04906421
Public ClinicalTrials.gov record NCT04906421. 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 2B, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Efficacy of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (FASCINATE-2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH). Subjects will be randomly assigned toTVB-2640 or matching placebo PO QD for 52 weeks, with the first dose administered on Day 1.
Study identification
- NCT ID
- NCT04906421
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 168 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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 12, 2021 (Actual)
- Primary completion
- Oct 2, 2023 (Actual)
- Completion
- Oct 2, 2023 (Actual)
- Last update posted
- May 9, 2025
2021 – 2023
United States locations
- U.S. sites
- 103
- U.S. states
- 27
- U.S. cities
- 83
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| North Alabama Health Research | Huntsville | Alabama | 35801 | — |
| North Alabama GI Research Center | Madison | Alabama | 35758 | — |
| GI Alliance Arizona Digestive Health-Sun City | Sun City | Arizona | 85351 | — |
| ARcare Center for Clinical Research, LLC - Conway | Conway | Arkansas | 72032 | — |
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72205 | — |
| Liver Wellness Center | Little Rock | Arkansas | 72205 | — |
| Citrus Valley Gastroenterology | Covina | California | 91723 | — |
| UCSD, NAFLD Research Center / Altman Clinical and Translational Research Institute | La Jolla | California | 92093 | — |
| Om Research LLC | Lancaster | California | 93534 | — |
| Clinical Trials Research | Lincoln | California | 95648 | — |
| Digestive Health Research of Southern California LLC | Long Beach | California | 90808 | — |
| Digestive Health Research of Southern California | Long Beach | California | 90808 | — |
| Catalina Research Institute, LLC | Montclair | California | 91763 | — |
| United Medical Doctors | Murrieta | California | 92563 | — |
| Palmtree Clinical Research, INC | Palm Springs | California | 92262 | — |
| IVGI | Ventura | California | 93003 | — |
| Gastro Florida | Clearwater | Florida | 33761 | — |
| Tampa Bay Medical Research, Inc. | Clearwater | Florida | 33761 | — |
| American Research Institute, Inc | Cutler Bay | Florida | 33157 | — |
| Top Medical Research, Inc | Cutler Bay | Florida | 33189 | — |
| Covenant Metabolic Specialists, LLC | Fort Myers | Florida | 33912 | — |
| Direct Helpers Research Center | Hialeah | Florida | 33012 | — |
| Miguel A Rebollar, MD PA | Hialeah | Florida | 33012 | — |
| Global Research Associates | Homestead | Florida | 33030 | — |
| Ocala GI Research dba Lake Center for Clinical Research, LLC | Lady Lake | Florida | 32159 | — |
| Accel Research Site - Maitland | Maitland | Florida | 32751 | — |
| CPMI | Miami | Florida | 33014 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Sanchez Clinical Research, Inc | Miami | Florida | 33157 | — |
| Genoma Research Group, Inc | Miami | Florida | 33173 | — |
| Panax Clinical Research | Miami Lakes | Florida | 33014 | — |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | — |
| Professional Medical Research | Miramar | Florida | 33025 | — |
| Ocala GI Research, LLC | Ocala | Florida | 34471 | — |
| Innovation Medical Research Center, Inc | Palmetto Bay | Florida | 33157 | — |
| Pensacola GI Research Center, LLC | Pensacola | Florida | 32503 | — |
| Covenant Metabolic Specialists, LLC | Sarasota | Florida | 34240 | — |
| Headlands Research Sarasota | Sarasota | Florida | 34243 | — |
| Conquest Research | Winter Park | Florida | 32789 | — |
| Summit Clinical Research | Athens | Georgia | 30607 | — |
| Southeast Clinical Research Center | Dalton | Georgia | 30720 | — |
| Care Access Research | Fairview Heights | Illinois | 62208 | — |
| Gastroenterology Health Partners, PLLC | New Albany | Indiana | 47150 | — |
| Digestive Research Alliance of Michiana | South Bend | Indiana | 46635 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Kansas Medical Clinic, PA | Topeka | Kansas | 66606 | — |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71105 | — |
| Woodholme Gastroenterology Associates | Glen Burnie | Maryland | 21061 | — |
| Greater Boston Gastroenterology | Boston | Massachusetts | 01702 | — |
| Greater Boston Gastroenterology | Framingham | Massachusetts | 01702 | — |
| FC Research LLC | South Dartmouth | Massachusetts | 02747 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| GI Associates Research, LLC | Columbia | Missouri | 65201 | — |
| Sierra Clinical Research | Las Vegas | Nevada | 89106 | — |
| Jubilee Clinical Research, Inc. | Las Vegas | Nevada | 899106 | — |
| Care Access | Yonkers | New York | 10701 | — |
| University of North Carolina at Chapel Hill. UNC Liver Center | Chapel Hill | North Carolina | 27599 | — |
| Northeast GI Research Division | Concord | North Carolina | 28027 | — |
| ACME Medical Specialties PLCC | Lumberton | North Carolina | 28358 | — |
| Care Access Research | Lumberton | North Carolina | 28358 | — |
| Lucas Research, Inc. | Morehead City | North Carolina | 28557 | — |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| DSI Research, LLC - Northridge | Dayton | Ohio | 45414 | — |
| Care Access Research | Poland | Ohio | 44514 | — |
| DDSI Clinical Trials | Oklahoma City | Oklahoma | 73112 | — |
| University of Gastroenterology | Providence | Rhode Island | 02905 | — |
| Care Access Research | Warwick | Rhode Island | 02886 | — |
| Ralph H. Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | — |
| Columbia Digestive Health Research, LLC | Columbia | South Carolina | 29204 | — |
| Digestive Disease Research Center LLC | Greenwood | South Carolina | 29646 | — |
| Rapid City Medical Center, LLP | Rapid City | South Dakota | 57701 | — |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Gastro One | Cordova | Tennessee | 38018 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Digestive Health Research | Lebanon | Tennessee | 37090 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Pinnacle Clinical Research | Austin | Texas | 78557 | — |
| Apex Mobile Clinical Research, LLC | Bellaire | Texas | 77401 | — |
| Texas Digestive Disease Consultants - Cedar Park | Cedar Park | Texas | 78613 | — |
| The Liver Institute at Methodist Health System | Dallas | Texas | 75203 | — |
| GI Alliance -Texas Digestive Disease Consultants | Dallas | Texas | 75246 | — |
| South Texas Research Institute | Edinburg | Texas | 78539 | — |
| Texas Digestive Disease Consultants - Fort Worth | Fort Worth | Texas | 76104 | — |
| Baylor College of Medicine - Advanced Liver Therapies | Houston | Texas | 77030 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| GI Alliance / Texas Digestive Disease Consultants | Lubbock | Texas | 79410 | — |
| Centex Studies | McAllen | Texas | 78504 | — |
| ClinRx Research LLC | Plano | Texas | 75023 | — |
| American Research Corporation | San Antonio | Texas | 78215 | — |
| Clinical Trials of Texas Inc. | San Antonio | Texas | 78229 | — |
| Diabetes and Glandular Disease Clinic, P.A. | San Antonio | Texas | 78229 | — |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | — |
| Pinnacle Clinical Research | San Antonio | Texas | 78240 | — |
| Sherman Clinical Research | Sherman | Texas | 75092 | — |
| Impact Research Institute | Waco | Texas | 76710 | — |
| Digestive Health Research of North Texas | Wichita Falls | Texas | 76301 | — |
| Care Access | Ogden | Utah | 84403 | — |
| Bon Secours Richmond Community Hospital LLC d/b/a Bon Secours Liver Institute of Richmond | Richmond | Virginia | 23226 | — |
| GI Select Health Research, LLC | Richmond | Virginia | 23236 | — |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | — |
| Gastroenterology Consultants of SW Virginia | Roanoke | Virginia | 24014 | — |
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 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04906421, 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 May 9, 2025 · Synced Oct 21, 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 NCT04906421 live on ClinicalTrials.gov.