ClinicalTrials.gov record
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
ClinicalTrials.gov ID: NCT04849728
Public ClinicalTrials.gov record NCT04849728. 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 Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis Stages F2 and F3
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Study identification
- NCT ID
- NCT04849728
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,000 participants
Conditions and interventions
Conditions
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 19, 2021 (Actual)
- Primary completion
- Sep 30, 2027 (Estimated)
- Completion
- Sep 30, 2027 (Estimated)
- Last update posted
- Jul 2, 2026
2021 – 2027
United States locations
- U.S. sites
- 194
- U.S. states
- 37
- U.S. cities
- 145
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Objective Health - Birmingham Gastroenterology Associates | Birmingham | Alabama | 35209 | — |
| Digestive Health Specialist of the Southeast | Dothan | Alabama | 36305 | — |
| North Alabama GI Research Center llc | Madison | Alabama | 60602 | — |
| The Institute For Liver Health - Chandler | Chandler | Arizona | 85224-5688 | — |
| Arizona Liver Health - Peoria | Peoria | Arizona | 85381 | — |
| Dignity Health - St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| Adobe Gastroenterology | Tucson | Arizona | 85712 | — |
| Arizona Liver Health | Tucson | Arizona | 85712 | — |
| ARcare Center for Clinical Research - Conway | Conway | Arkansas | 72032 | — |
| ARcare Center for Clinical Research | Little Rock | Arkansas | 72205 | — |
| Arkansas Diagnostic Center | Little Rock | Arkansas | 72205 | — |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| Summit - Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | — |
| Fomatmedicalresearch | Camarillo | California | 93011 | — |
| GW Research | Chula Vista | California | 91910 | — |
| Velocity Clinical Research, Chula Vista | Chula Vista | California | 91911 | — |
| TriWest Research Associates | El Cajon | California | 92020 | — |
| Cure Clinical Research, LLC | Fountain Valley | California | 92708 | — |
| SC Clinical Research | Garden Grove | California | 92844 | — |
| Velocity Clinical Research - Gardena | Gardena | California | 90247 | — |
| National Research Institute - Santa Ana | Huntington Park | California | 92704 | — |
| The Clinical Trials Network - Gastro Care Institute | Lancaster | California | 93534 | — |
| National Research Institute - Westlake | Los Angeles | California | 90057 | — |
| National Research Institute - Panorama City | Panorama City | California | 91402 | — |
| California Liver Reearch | Pasadena | California | 91105 | — |
| Cadena Care Institute | Poway | California | 92064 | — |
| Stanford University Medical Center | Redwood City | California | 94063 | — |
| Research and Education, Inc. | San Diego | California | 92111 | — |
| California Pacific Medical Center Research Institute | San Francisco | California | 64107 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Silicon Valley Research Institute | San Jose | California | 95128 | — |
| Clinical Trial Management Services | Thousand Oaks | California | 91360 | — |
| San Fernando Valley Health Institute | Van Nuys | California | 91405 | — |
| South Denver Gastroenterology - Swedish Medical Center Office | Englewood | Colorado | 80113 | — |
| Yale School of Medicine | New Haven | Connecticut | 06520 | — |
| Synergy Healthcare | Bradenton | Florida | 34208 | — |
| Florida Research Institute | Bradenton | Florida | 34209 | — |
| Tampa Bay Medical Research | Clearwater | Florida | 33761 | — |
| Gastro Florida | Clearwater | Florida | 33762 | — |
| Hi Tech and Global Research, LLC | Coral Gables | Florida | 33134 | — |
| JY Research Institute Inc. | Cutler Bay | Florida | 33189 | — |
| Top Medical Research | Cutler Bay | Florida | 33189 | — |
| Doral Medical Research, LLC | Hialeah | Florida | 33016 | — |
| Palmetto Research | Hialeah | Florida | 33016 | — |
| Florida Research Institute | Lakewood Rch | Florida | 34211 | — |
| Galenus Group | Lehigh Acres | Florida | 33936 | — |
| Accel Research Sites | Maitland | Florida | 32751 | — |
| Centor for Advanced Gastroenterology - Main Office - Maitland | Maitland | Florida | 32751 | — |
| Florida Vascular Research | Miami | Florida | 33012 | — |
| Life Medical Research Group | Miami | Florida | 33122 | — |
| Schiff Center for Liver Diseases | Miami | Florida | 33136 | — |
| D&H National Research Centers | Miami | Florida | 33155 | — |
| Future Care Solution | Miami | Florida | 33165 | — |
| Genoma Research Group | Miami | Florida | 33165 | — |
| Gastro Health - Galloway | Miami | Florida | 33173 | — |
| Pro Live Medical Research | Miami | Florida | 33175 | — |
| Miami Dade Medical Research Institute | Miami | Florida | 33176 | — |
| Clinical Trials Services Corporation | Miami | Florida | 33181 | — |
| Advanced Research Institute | New Port Richey | Florida | 34653 | — |
| Sensible Healthcare Clinical Research | Ocoee | Florida | 34761 | — |
| AdventHealth Transplant Institute | Orlando | Florida | 32804 | — |
| Digestive and Liver Center of Florida - Orlando | Orlando | Florida | 32825 | — |
| IMIC Research - International Medical Investigations Centers | Palmetto Bay | Florida | 33157 | — |
| American Research Centers of Florida | Pembroke Pines | Florida | 33027 | — |
| Pensacola GI Research Center | Pensacola | Florida | 32503 | — |
| Eminat, LLC | Plantation | Florida | 33317 | — |
| D & H Pompano Research Center | Pompano Beach | Florida | 33064 | — |
| NAPA Research | Pompano Beach | Florida | 33064 | — |
| Covenant Metabolic Specialists LLC - Sarasota | Sarasota | Florida | 34420 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Cleveland Clinic Florida | Weston | Florida | 33331 | — |
| Florida Medical Clinic - Zephyrhills | Zephyrhills | Florida | 33542 | — |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | — |
| Oracle Clinical Research | College Park | Georgia | 30349 | — |
| IACT Health | Columbus | Georgia | 31904 | — |
| Southeast Clinical Research Center | Dalton | Georgia | 30720 | — |
| Grand Teton Research Group, PLLC | Idaho Falls | Idaho | 83404 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Chicago | Chicago | Illinois | 60611 | — |
| NorthShore University HealthSystem | Skokie | Illinois | 60077 | — |
| ASHA Clinical Research - Munster | Hammond | Indiana | 46324 | — |
| Heartland Medical Research | Clive | Iowa | 50325 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Arizona Digestive Health - Sun City | Kansas City | Kansas | 66160 | — |
| University of Kansas Medical Center Research Institute | Kansas City | Kansas | 66160 | — |
| Kansas Medical Clinic - Gastroenterology | Topeka | Kansas | 66606 | — |
| University of Kentucky | Lexington | Kentucky | 40506-0032 | — |
| Tandem Clinical Research GI | Houma | Louisiana | 70363 | — |
| Combined Gastro Research LLC | Lafayette | Louisiana | 70503 | — |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | — |
| Metropolitan Gastroenterology Associates - Metairie | Metairie | Louisiana | 70006 | — |
| Louisiana Research Center LLC | Shreveport | Louisiana | 71103 | — |
| Mercy Medical Center - Mcauley Plaza | Baltimore | Maryland | 21202 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Digestive Disease Associates - Catonsville | Catonsville | Maryland | 21228 | — |
| Chevy Chase Clinical Research | Chevy Chase | Maryland | 20815 | — |
| Mid-Atlantic GI Research | Greenbelt | Maryland | 20770 | — |
| Meritus Center for Clinical Research | Hagerstown | Maryland | 21742 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| Beth Israel Deaconess Medical Center - Liver Center | Boston | Massachusetts | 02215 | — |
| NECCR Prima Care Research, LLC | Fall River | Massachusetts | 02721 | — |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | — |
| MNGI Digestive Health - Northeast Minneapolis Clinic | Minneapolis | Minnesota | 55413 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Gastrointestinal Associates & Endoscopy Center - Flowood | Flowood | Mississippi | 39232 | — |
| Galen Research | Chesterfield | Missouri | 63005 | — |
| Gastrointestinal (GI) Associates L.L.P. | Columbia | Missouri | 65201 | — |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | — |
| Washington University School of Medicine in St. Louis | St Louis | Missouri | 63110 | — |
| Sierra Clinical Research - Las Vegas | Las Vegas | Nevada | 89106 | — |
| Southwest Gastroenterology Associates | Albuquerque | New Mexico | 87109 | — |
| State University of New York - University at Buffalo | Buffalo | New York | 14203 | — |
| New York University Langone Gastroenterology Associates | 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 | — |
| Tandem Clinical Research - New York Clinic | New York | New York | 10033 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Richmond University Medical Center | Staten Island | New York | 10310 | — |
| Charlotte Gastroenterology and Hepatology - Randolph Road Office | Charlotte | North Carolina | 28207 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Icahn School of Medicine at Mount Sinai | Durham | North Carolina | 27710 | — |
| Cumberland Research Associates | Fayetteville | North Carolina | 28304 | — |
| Carolina Digestive Diseases | Greenville | North Carolina | 27834 | — |
| Lucas Research, Inc | Morehead City | North Carolina | 28557 | — |
| Gastroenterology of the Piedmont, PA - Salem Office | Winston-Salem | North Carolina | 27103 | — |
| Consultants for Clinical Research - Montgomery Office | Cincinnati | Ohio | 45249 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| The Ohio State University | Columbus | Ohio | 43201 | — |
| Aventiv Research - Columbus | Columbus | Ohio | 43213 | — |
| Centricity (Aventiv) Research - Columbus | Columbus | Ohio | 43213 | — |
| Digestive Specialists - Dayton | Dayton | Ohio | 45414 | — |
| Ohio Gastroenterology Group, Inc. - Olentangy Office | Dublin | Ohio | 43016 | — |
| Great Lakes Gastroenterology Research - Mentor | Mentor | Ohio | 44060 | — |
| North Shore Gastroenterology | Westlake | Ohio | 44145 | — |
| Options Health Research | Tulsa | Oklahoma | 74104 | — |
| Veterans Affairs Pittsburgh Healthcare System - University Drive Campus | Pittsburgh | Pennsylvania | 15240 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| Clinovacare Medical Clinical Research Center | West Columbia | South Carolina | 29169 | — |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | — |
| Gastro One - Germantown Office - Wolf Park Drive | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | — |
| Accelemed Research Institute | Austin | Texas | 78745 | — |
| South Texas Research Institute - Brownsville | Brownsville | Texas | 78520 | — |
| Velocity Clinical Research - Austin | Cedar Park | Texas | 78613 | — |
| The Liver Institute at Methodist Dallas | Dallas | Texas | 75203 | — |
| Liver Center of Texas | Dallas | Texas | 75234 | — |
| GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown | Dallas | Texas | 75246 | — |
| Soma Clinical Trials | Denison | Texas | 75020 | — |
| South Texas Research Institute - Edinburg | Edinburg | Texas | 78539 | — |
| Care United Medical Center - Forney | Forney | Texas | 75126 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Digestive Health Associates of Texas - Rockwall | Garland | Texas | 75044 | — |
| Houston Methodist Hospital | Houston | Texas | 77030 | — |
| Liver Associates of Texas | Houston | Texas | 77030 | — |
| Liver Specialists of Texas | Houston | Texas | 77030 | — |
| Houston Research Institute (HRI) | Houston | Texas | 77079 | — |
| Pioneer Research Solutions | Houston | Texas | 77099 | — |
| Summit - Pinnacle Clinical Research - Austin | Live Oak | Texas | 78233 | — |
| GI Alliance - Lubbock Digestive Disease Associates - Lubbock | Lubbock | Texas | 79410 | — |
| GI Alliance - Mansfield | Mansfield | Texas | 76063 | — |
| Koncord Research - McAllen LLC | McAllen | Texas | 78504 | — |
| Koncord Research-McAllen LLC | McAllen | Texas | 78504 | — |
| Quality Research - San Antonio | San Antonio | Texas | 78209 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Texas Liver Institute/American Research Corporation | San Antonio | Texas | 78215 | — |
| University of California San Diego | San Antonio | Texas | 78215 | — |
| Pinnacle Clinical Research - San Antonio | San Antonio | Texas | 78229 | — |
| Sherman Clinical Research | Sherman | Texas | 75092 | — |
| Olympus Clinical Research | Sugar Land | Texas | 77478 | — |
| Impact Research Institute | Waco | Texas | 76710 | — |
| Digestive Health Research of Central Texas | Waco | Texas | 76712 | — |
| GI Alliance - Bay Area Gastroenterology - Webster | Webster | Texas | 77598 | — |
| Digestive Health Research of North Texas | Wichita Falls | Texas | 76301 | — |
| Lone Peak Family Health | Draper | Utah | 84020 | — |
| Physicians' Research Options LLC - Draper UT/Lone Peak Family Clinic | Draper | Utah | 84020 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| Emeritas Research Group | Leesburg | Virginia | 20176 | — |
| Topography Health, Inc. | Manassas | Virginia | 20110 | — |
| Bon Secours Liver Institute of Hampton Roads | Newport News | Virginia | 23602 | — |
| Digestive & Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| GI Select Health Research, LLC | Richmond | Virginia | 23236 | — |
| Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond | Richmond | Virginia | 23249 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | — |
| Liver Institute Northwest | Seattle | Washington | 98105 | — |
| Froedtert and Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 265 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04849728, 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 Jul 2, 2026 · Synced Oct 17, 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 NCT04849728 live on ClinicalTrials.gov.