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 )

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by Inventiva Pharma
Sponsor
Inventiva Pharma
Information Provided by (Responsible Party)
Inventiva Pharma
Clinicaltrials.gov Identifier
NCT04849728
Other Study ID Numbers:
337HNAS20011
First Submitted
April 15, 2021
First Posted
April 18, 2021
Last Update Posted
May 19, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Primary objectives

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage F2 or F3 and consists of 2 sequential parts - an initial double-blind placebo-controlled (DBPC) period (Part A) followed by a double-blind active treatment extension (ATE) period (Part B), with the following primary objectives:

Part A To assess the safety and efficacy of lanifibranor compared to placebo on 'NASH resolution and improvement of fibrosis' assessed by liver histology.

Part B To assess the safety of lanifibranor beyond the DBPC period. Secondary objectives

Key secondary objectives of Part 1:

* To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis

* To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH

Other secondary objectives of both Part 1 and Part 2:

* To assess the effect of lanifibranor on other key histological features of NASH (only for DBPC period)

* To assess the effect of lanifibranor on NASH resolution and improvement of fibrosis in diabetic patients (only for DBPC period)

* To assess the effect of lanifibranor on liver tests

* To assess the effect of lanifibranor on glycaemic parameters

* To assess the effect of lanifibranor on lipid parameters

* To assess the effect of lanifibranor on liver stiffness and steatosis assessed by elastography.

* To assess the effect of lanifibranor on health-related quality of life

* To assess the safety of lanifibranor

* To assess population PK modeling through plasma levels of lanifibranor using sparse sampling scheme (only for DBPC period)

Condition or DiseaseIntervention/Treatment
NASH - Nonalcoholic Steatohepatitis
Drug: IVA337Drug: IVA337Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1000 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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
Study Start DateAugust 18, 2021
Actual Primary Completion Date1yr 3mos from now
Actual Study Completion Date1yr 3mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Lanifibranor (IVA 337) (800 mg/day)
2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --\> once a day (quaque die, QD)
Drug: IVA337
A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.
Lanifibranor (IVA 337) (1200 mg/day)
3 Lanifibranor tablets 400mg with food --\> once a day (quaque die, QD)
Drug: IVA337
A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.
Matching placebo
3 Placebo to match tablets with food --\> once a day (quaque die, QD)
Drug: Placebo
A total of 1000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part A and Part B.

Outcome Measures

Primary Outcome Measures
  1. Resolution of NASH and improvement of fibrosis
    Part A: DBPC: Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline
  2. Safety Analyses
    Part B: ATE: * Using the DBPC on-treatment period, comparing the 2 active arms versus placebo * Using the DBPC +ATE on treatment periods, assessing the 2 active arms. For adverse events, adjudicated liver events, and DILI and MACE events, in addition to the raw cumulative incidence proportions, the exposure-adjusted incidence rates will be provided based on the time patients are at risk.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Male or female, aged ≥18 years at the time of signing informed consent 2. Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF): 1. Steatosis score ≥1 2. Activity score: A3 or A4 3. Fibrosis score: F2 or F3 3. No qualitative change in dose for the drugs listed below: 1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months 2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months 3. Statins: for at least 3 months 4. No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening 5. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods) 6. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation.
Exclusion Criteria
Liver-related: 1. Documented causes of chronic liver disease other than NASH 2. Histologically documented liver cirrhosis (fibrosis stage F4) 3. History or current diagnosis of hepatocellular carcinoma (HCC) 4. History of or planned liver transplant 5. Positive human immunodeficiency virus (HIV) serology 6. ALT or AST \>5 × ULN 7. AST\<0.6 ULN if the liver biopsy has to be performed in the scope of the study 8. Abnormal synthetic liver function as defined by Screening central laboratory evaluation 9. Haemoglobin \<110 g/L (11 g/dL) for females and \<120 g/L (12 g/dL) for males 10. Patient currently receiving any approved treatment for NASH or obesity 11. Current or recent history (\<5 years) of significant alcohol consumption 12. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy Glycaemia related: 13. HbA1c \>9% at Screening 14. Diabetes mellitus other than type 2 15. Current treatment with insulin 16. Treatment with PPAR-gamma agonists (thiazolidinediones \[TZDs\]) 12 months before screening or historical biopsy. Obesity related: 17. Bariatric surgery: Restrictive procedures are allowed, if performed \>6 months prior to the qualifying liver biopsy; malabsorptive procedures and procedures combining both restrictive and malabsorptive methods are not allowed within 5 years of the qualifying liver biopsy. Cardiovascular related: 18. History of heart failure with reduced left ventricular ejection fraction (LVEF) 19. Atrial fibrillation requiring anticoagulation 20. Unstable heart failure 21. Uncontrolled hypertension at Screening (values \>160/100 mm Hg) General safety: 22. Women currently breastfeeding 23. Previous exposure to lanifibranor 24. Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer 25. Concomitant treatment with PPAR-alpha agonists (fibrates)

Contacts and Locations

Sponsors and CollaboratorsInventiva Pharma
Locations
Objective Health - Birmingham Gastroenterology Associates | Birmingham Alabama, United States, 35209Digestive Health Specialist of the Southeast | Dothan Alabama, United States, 36305North Alabama GI Research Center llc | Madison Alabama, United States, 60602The Institute For Liver Health - Chandler | Chandler Arizona, United States, 85224-5688Arizona Liver Health - Peoria | Peoria Arizona, United States, 85381Dignity Health - St. Joseph's Hospital and Medical Center | Phoenix Arizona, United States, 85013Saint Joseph's Hospital and Medical Center | Phoenix Arizona, United States, 85013Adobe Gastroenterology | Tucson Arizona, United States, 85712Arizona Liver Health | Tucson Arizona, United States, 85712ARcare Center for Clinical Research - Conway | Conway Arkansas, United States, 72032ARcare Center for Clinical Research | Little Rock Arkansas, United States, 72205Arkansas Diagnostic Center | Little Rock Arkansas, United States, 72205Arkansas Gastroenterology | North Little Rock Arkansas, United States, 72117Summit - Arkansas Gastroenterology | North Little Rock Arkansas, United States, 72117Fomatmedicalresearch | Camarillo California, United States, 93011GW Research | Chula Vista California, United States, 91910Velocity Clinical Research, Chula Vista | Chula Vista California, United States, 91911TriWest Research Associates | El Cajon California, United States, 92020Cure Clinical Research, LLC | Fountain Valley California, United States, 92708SC Clinical Research | Garden Grove California, United States, 92844Velocity Clinical Research - Gardena | Gardena California, United States, 90247National Research Institute - Santa Ana | Huntington Park California, United States, 92704The Clinical Trials Network - Gastro Care Institute | Lancaster California, United States, 93534National Research Institute - Westlake | Los Angeles California, United States, 90057National Research Institute - Panorama City | Panorama City California, United States, 91402California Liver Reearch | Pasadena California, United States, 91105Cadena Care Institute | Poway California, United States, 92064Stanford University Medical Center | Redwood City California, United States, 94063Research and Education, Inc. | San Diego California, United States, 92111California Pacific Medical Center Research Institute | San Francisco California, United States, 64107Quest Clinical Research | San Francisco California, United States, 94115Silicon Valley Research Institute | San Jose California, United States, 95128Clinical Trial Management Services | Thousand Oaks California, United States, 91360San Fernando Valley Health Institute | Van Nuys California, United States, 91405South Denver Gastroenterology - Swedish Medical Center Office | Englewood Colorado, United States, 80113Yale School of Medicine | New Haven Connecticut, United States, 06520Synergy Healthcare | Bradenton Florida, United States, 34208Florida Research Institute | Bradenton Florida, United States, 34209Tampa Bay Medical Research | Clearwater Florida, United States, 33761Gastro Florida | Clearwater Florida, United States, 33762Hi Tech and Global Research, LLC | Coral Gables Florida, United States, 33134JY Research Institute Inc. | Cutler Bay Florida, United States, 33189Top Medical Research | Cutler Bay Florida, United States, 33189Doral Medical Research, LLC | Hialeah Florida, United States, 33016Palmetto Research | Hialeah Florida, United States, 33016Florida Research Institute | Lakewood Rch Florida, United States, 34211Galenus Group | Lehigh Acres Florida, United States, 33936Accel Research Sites | Maitland Florida, United States, 32751Centor for Advanced Gastroenterology - Main Office - Maitland | Maitland Florida, United States, 32751Florida Vascular Research | Miami Florida, United States, 33012Life Medical Research Group | Miami Florida, United States, 33122Schiff Center for Liver Diseases | Miami Florida, United States, 33136D&H National Research Centers | Miami Florida, United States, 33155Future Care Solution | Miami Florida, United States, 33165Genoma Research Group | Miami Florida, United States, 33165Gastro Health - Galloway | Miami Florida, United States, 33173Pro Live Medical Research | Miami Florida, United States, 33175Miami Dade Medical Research Institute | Miami Florida, United States, 33176Clinical Trials Services Corporation | Miami Florida, United States, 33181Advanced Research Institute | New Port Richey Florida, United States, 34653Sensible Healthcare Clinical Research | Ocoee Florida, United States, 34761AdventHealth Transplant Institute | Orlando Florida, United States, 32804Digestive and Liver Center of Florida - Orlando | Orlando Florida, United States, 32825IMIC Research - International Medical Investigations Centers | Palmetto Bay Florida, United States, 33157American Research Centers of Florida | Pembroke Pines Florida, United States, 33027Pensacola GI Research Center | Pensacola Florida, United States, 32503Eminat, LLC | Plantation Florida, United States, 33317D & H Pompano Research Center | Pompano Beach Florida, United States, 33064NAPA Research | Pompano Beach Florida, United States, 33064Covenant Metabolic Specialists LLC - Sarasota | Sarasota Florida, United States, 34420Tampa General Hospital | Tampa Florida, United States, 33606Cleveland Clinic Florida | Weston Florida, United States, 33331Florida Medical Clinic - Zephyrhills | Zephyrhills Florida, United States, 33542Digestive Healthcare of Georgia | Atlanta Georgia, United States, 30309Oracle Clinical Research | College Park Georgia, United States, 30349IACT Health | Columbus Georgia, United States, 31904Southeast Clinical Research Center | Dalton Georgia, United States, 30720Grand Teton Research Group, PLLC | Idaho Falls Idaho, United States, 83404Northwestern University | Chicago Illinois, United States, 60611University of Chicago | Chicago Illinois, United States, 60611NorthShore University HealthSystem | Skokie Illinois, United States, 60077ASHA Clinical Research - Munster | Hammond Indiana, United States, 46324Heartland Medical Research | Clive Iowa, United States, 50325University of Iowa Hospitals and Clinics | Iowa City Iowa, United States, 52242Arizona Digestive Health - Sun City | Kansas City Kansas, United States, 66160University of Kansas Medical Center Research Institute | Kansas City Kansas, United States, 66160Kansas Medical Clinic - Gastroenterology | Topeka Kansas, United States, 66606University of Kentucky | Lexington Kentucky, United States, 40506-0032Tandem Clinical Research GI | Houma Louisiana, United States, 70363Combined Gastro Research LLC | Lafayette Louisiana, United States, 70503Tandem Clinical Research | Marrero Louisiana, United States, 70072Metropolitan Gastroenterology Associates - Metairie | Metairie Louisiana, United States, 70006Louisiana Research Center LLC | Shreveport Louisiana, United States, 71103Mercy Medical Center - Mcauley Plaza | Baltimore Maryland, United States, 21202The Johns Hopkins Hospital | Baltimore Maryland, United States, 21287Digestive Disease Associates - Catonsville | Catonsville Maryland, United States, 21228Chevy Chase Clinical Research | Chevy Chase Maryland, United States, 20815Mid-Atlantic GI Research | Greenbelt Maryland, United States, 20770Meritus Center for Clinical Research | Hagerstown Maryland, United States, 21742Massachusetts General Hospital | Boston Massachusetts, United States, 02114Boston Medical Center | Boston Massachusetts, United States, 02118Beth Israel Deaconess Medical Center - Liver Center | Boston Massachusetts, United States, 02215NECCR Prima Care Research, LLC | Fall River Massachusetts, United States, 02721Clinical Research Institute of Michigan | Chesterfield Michigan, United States, 48047Henry Ford Health System | Detroit Michigan, United States, 48202Gastroenterology Associates of Western Michigan | Wyoming Michigan, United States, 49519MNGI Digestive Health - Northeast Minneapolis Clinic | Minneapolis Minnesota, United States, 55413Mayo Clinic - Rochester | Rochester Minnesota, United States, 55905Gastrointestinal Associates & Endoscopy Center - Flowood | Flowood Mississippi, United States, 39232Galen Research | Chesterfield Missouri, United States, 63005Gastrointestinal (GI) Associates L.L.P. | Columbia Missouri, United States, 65201Kansas City Research Institute | Kansas City Missouri, United States, 64131Washington University School of Medicine in St. Louis | St Louis Missouri, United States, 63110Sierra Clinical Research - Las Vegas | Las Vegas Nevada, United States, 89106Southwest Gastroenterology Associates | Albuquerque New Mexico, United States, 87109State University of New York - University at Buffalo | Buffalo New York, United States, 14203New York University Langone Gastroenterology Associates | New York New York, United States, 10016Weill Cornell Medical College | New York New York, United States, 10021Icahn School of Medicine at Mount Sinai | New York New York, United States, 10029Tandem Clinical Research - New York Clinic | New York New York, United States, 10033University of Rochester Medical Center | Rochester New York, United States, 14642Richmond University Medical Center | Staten Island New York, United States, 10310Charlotte Gastroenterology and Hepatology - Randolph Road Office | Charlotte North Carolina, United States, 28207Duke University Medical Center | Durham North Carolina, United States, 27710Icahn School of Medicine at Mount Sinai | Durham North Carolina, United States, 27710Cumberland Research Associates | Fayetteville North Carolina, United States, 28304Carolina Digestive Diseases | Greenville North Carolina, United States, 27834Lucas Research, Inc | Morehead City North Carolina, United States, 28557Gastroenterology of the Piedmont, PA - Salem Office | Winston-Salem North Carolina, United States, 27103Consultants for Clinical Research - Montgomery Office | Cincinnati Ohio, United States, 45249University Hospitals Case Medical Center | Cleveland Ohio, United States, 44106The Ohio State University | Columbus Ohio, United States, 43201Aventiv Research - Columbus | Columbus Ohio, United States, 43213Centricity (Aventiv) Research - Columbus | Columbus Ohio, United States, 43213Digestive Specialists - Dayton | Dayton Ohio, United States, 45414Ohio Gastroenterology Group, Inc. - Olentangy Office | Dublin Ohio, United States, 43016Great Lakes Gastroenterology Research - Mentor | Mentor Ohio, United States, 44060North Shore Gastroenterology | Westlake Ohio, United States, 44145Options Health Research | Tulsa Oklahoma, United States, 74104Veterans Affairs Pittsburgh Healthcare System - University Drive Campus | Pittsburgh Pennsylvania, United States, 15240University of Pittsburgh Medical Center | Pittsburgh Pennsylvania, United States, 15261Medical University of South Carolina | Charleston South Carolina, United States, 29425Palmetto Clinical Research | Summerville South Carolina, United States, 29485Clinovacare Medical Clinical Research Center | West Columbia South Carolina, United States, 29169Rapid City Medical Center | Rapid City South Dakota, United States, 57701Gastro One - Germantown Office - Wolf Park Drive | Germantown Tennessee, United States, 38138Vanderbilt University Medical Center | Nashville Tennessee, United States, 37232Texas Clinical Research Institute | Arlington Texas, United States, 76012Accelemed Research Institute | Austin Texas, United States, 78745South Texas Research Institute - Brownsville | Brownsville Texas, United States, 78520Velocity Clinical Research - Austin | Cedar Park Texas, United States, 78613The Liver Institute at Methodist Dallas | Dallas Texas, United States, 75203Liver Center of Texas | Dallas Texas, United States, 75234GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown | Dallas Texas, United States, 75246Soma Clinical Trials | Denison Texas, United States, 75020South Texas Research Institute - Edinburg | Edinburg Texas, United States, 78539Care United Medical Center - Forney | Forney Texas, United States, 75126Brooke Army Medical Center | Fort Sam Houston Texas, United States, 78234Digestive Health Associates of Texas - Rockwall | Garland Texas, United States, 75044Houston Methodist Hospital | Houston Texas, United States, 77030Liver Associates of Texas | Houston Texas, United States, 77030Liver Specialists of Texas | Houston Texas, United States, 77030Houston Research Institute (HRI) | Houston Texas, United States, 77079Pioneer Research Solutions | Houston Texas, United States, 77099Summit - Pinnacle Clinical Research - Austin | Live Oak Texas, United States, 78233GI Alliance - Lubbock Digestive Disease Associates - Lubbock | Lubbock Texas, United States, 79410GI Alliance - Mansfield | Mansfield Texas, United States, 76063Koncord Research - McAllen LLC | McAllen Texas, United States, 78504Koncord Research-McAllen LLC | McAllen Texas, United States, 78504Quality Research - San Antonio | San Antonio Texas, United States, 78209Sun Research Institute | San Antonio Texas, United States, 78215Texas Liver Institute/American Research Corporation | San Antonio Texas, United States, 78215University of California San Diego | San Antonio Texas, United States, 78215Pinnacle Clinical Research - San Antonio | San Antonio Texas, United States, 78229Sherman Clinical Research | Sherman Texas, United States, 75092Olympus Clinical Research | Sugar Land Texas, United States, 77478Impact Research Institute | Waco Texas, United States, 76710Digestive Health Research of Central Texas | Waco Texas, United States, 76712GI Alliance - Bay Area Gastroenterology - Webster | Webster Texas, United States, 77598Digestive Health Research of North Texas | Wichita Falls Texas, United States, 76301Lone Peak Family Health | Draper Utah, United States, 84020Physicians' Research Options LLC - Draper UT/Lone Peak Family Clinic | Draper Utah, United States, 84020University of Utah School of Medicine | Salt Lake City Utah, United States, 84132University of Vermont Medical Center | Burlington Vermont, United States, 05401University of Virginia Health System | Charlottesville Virginia, United States, 22903Emeritas Research Group | Leesburg Virginia, United States, 20176Topography Health, Inc. | Manassas Virginia, United States, 20110Bon Secours Liver Institute of Hampton Roads | Newport News Virginia, United States, 23602Digestive & Liver Disease Specialists | Norfolk Virginia, United States, 23502GI Select Health Research, LLC | Richmond Virginia, United States, 23236Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond | Richmond Virginia, United States, 23249Virginia Commonwealth University | Richmond Virginia, United States, 23284Liver Institute Northwest | Seattle Washington, United States, 98105Froedtert and Medical College of Wisconsin | Milwaukee Wisconsin, United States, 53226Hospital Italiano de Buenos Aires | Ciudad Autónoma de Buenos Aires Buenos Aires, Argentina, C1199ABBHospital Italiano La Plata | La Plata Buenos Aires, Argentina, B1900AXIHospital Universitario Austral | Pilar Buenos Aires, Argentina, B1629AHJHospital Provincial del Centenario | Rosario Santa Fe Province, Argentina, S2002KDSHospital De Alta Complejidad en Red El Cruce | Buenos Aires , Argentina, C1124AADHospital Británico de Buenos Aires | Buenos Aires , Argentina, C1280AEBConcord Repatriation General Hospital | Concord New South Wales, Australia, 2139Campbelltown Hospital | Liverpool New South Wales, Australia, 2170Liverpool Hospital | Liverpool New South Wales, Australia, 2170Nepean Hospital | Penrith New South Wales, Australia, 2750Gallipoli Medical Research Foundation | Greenslopes Queensland, Australia, 4120Royal Brisbane and Women's Hospital | Herston Queensland, Australia, 4029Eastern Health - Australia | Box Hill Victoria, Australia, 3128Monash Medical Centre | Clayton Victoria, Australia, 3168Austin Health | Heidelberg Victoria, Australia, 3084Fiona Stanley Hospital | Murdoch Western Australia, Australia, 6150Royal Perth Hospital | Perth Western Australia, Australia, 6000Universitair Ziekenhuis Antwerpen | Edegem Antwerpen, Belgium, 2650Hôpital Erasme | Brussels Brussels Capital, Belgium, 1070Universitair Ziekenhuis Leuven - Campus Gasthuisberg | Leuven Flemish Brabant, Belgium, 3000Ziekenhuis Oost-Limburg - Campus Sint-Jan | Genk Limburg, Belgium, 3600Algemeen Ziekenhuis Maria Middelares | Ghent Oost-Vlaaderen, Belgium, 9000Universitair Ziekenhuis Gent | Ghent Oost-Vlaanderen, Belgium, 9000Vitaz | Sint-Niklaas Oost-Vlaanderen, Belgium, 9100Algemeen Ziekenhuis Delta - Campus Rumbeke | Roeselare West-Vlaanderen, Belgium, 8800Cliniques Universitaires Saint-Luc | Brussels , Belgium, 1200Centre Hospitalier Universitaire de Liège Site Sart Tilman | Liège , Belgium, B-4000Hospital das Clinicas da Universidade Federal de Minas Gerais | Belo Horizonte Minas Gerais, Brazil, 30130-100Hospital de Clínicas de Porto Alegre | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | Cerqueira César São Paulo, Brazil, 05403-000Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | Ribeirão Preto São Paulo, Brazil, 14051-140Fundação Faculdade Regional de Medicina de São José do Rio Preto | São José do Rio Preto São Paulo, Brazil, 15090-000University Multiprofile Hospital for Active Treatment St. Ivan Rilski | Sofia Sofia-Grad, Bulgaria, 1431University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov | Sofia Sofia-Grad, Bulgaria, 1612Acibadem City Clinic Tokuda Hospital | Sofia , Bulgaria, 1407Diagnostic Consultative Center Aleksandrovska | Sofia , Bulgaria, 1431Diagnostic Consulting Center 20 - Sofia Еооd | Sofia , Bulgaria, 1618Medical Center Medica Plus | Veliko Tarnovo , Bulgaria, 5006Heritage Medical Research Centre | Calgary Alberta, Canada, T2N 4Z6William Osler Health System - Brampton Civic Hospital | Brampton Ontario, Canada, L6R 3J7St. Joseph's Healthcare Hamilton - Charlton Campus | Hamilton Ontario, Canada, L8N 4A6University Health Network | Toronto Ontario, Canada, M5G 2C4Toronto Digestive Disease Associates | Vaughan Ontario, Canada, L4L 4Y7McGill University Health Centre | Montreal Quebec, Canada, H4A 3J1Centre de Médecine Métabolique de Lanaudière | Terrebonne Quebec, Canada, J6X 497Hospital San Juan de Dios de La Serena | La Serena Coquimbo Region, Chile, 1700000Centro De Investigaciones Clínicas Viña Del Mar | Viña del Mar Valparaiso, Chile, 2540364Pontificia Universidad Católica de Chile - Escuela de Medicina | Santiago , Chile, 8320000The First Affiliated Hospital of Anhui Medical University | Hefei Anhui, China, 230022Beijing Ditan Hospital Capital Medical University | Beijing Beijing Municipality, China, 100010Beijing Ditan Hospital, Capital Medical University | Beijing Beijing Municipality, China, Peking University First Hospital | Beijing Beijing Municipality, China, Peking University People's Hospital | Beijing Beijing Municipality, China, Chongqing university three gorges hospital | Chongqing Chongging, China, First Affiliated Hospital of the Army Military Medical University (Southwest Hospital) | Chongqing Chongging, China, The First Affiliated Hospital of Chongqing Medical University | Chongqing Chongqing Municipality, China, Beijing You'an Hospital,Capital Medical University | Beijing Fengtai, China, The First Affiliated Hospital of Fujian Medical University | Fuzhou Fujian, China, The First Hospital of Lanzhou University | Lanzhou Gansu, China, Guangzhou First People's Hospital | Guangzhou Guangdong, China, Nanfang Hospital of Southern Medical University | Guangzhou Guangdong, China, The Eighth Affiliated Hospital,GuangZhou Medical University | Guangzhou Guangdong, China, The First Affiliated Hospital Sun Yat-sen University | Guangzhou Guangdong, China, Peking University Shenzhen Hospital | Shenzhen Guangdong, China, 518036The First Affiliated Hospital of Guangxi Medical University | Nanning Guangxi, China, Guizhou Provincial People's Hospital | Guiyang Guizhou, China, The Affiliated Hospital of Guizhou Medical University | Guiyang Guizhou, China, The Third Hospital of Hebei Medical University | Shijiazhuang Hebei, China, 050052Heilongjiang Provincial Hospital | Harbin Heilongjiang, China, 150036Fourth Affiliated Hospital of Harbin Medical University | Harbin Heilongjiang, China, The First Affiliated Hospital of Henan University of Science and Technology | Luoyang Henan, China, Sanmenxia Central Hospital | Sanmenxia Henan, China, The Third Affiliated Hospital Of Xinxiang Medical University | Xinxiang Henan, China, 453000Henan Provincal People's Hospital | Zhengzhou Henan, China, The Sixth People's Hospital of Zhengzhou | Zhengzhou Henan, China, Zhengzhou First People's Hospital | Zhengzhou Henan, China, Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan Hubei, China, The Second Xiangya Hospital of Central South University | Changsha Hunan, China, 410699Yue Yang Central Hospital | Yueyang Hunan, China, 414000Nanjing Drum Tower Hospital | Nanjing Jiangsu, China, 210008Jiangsu Provincial People's Hospital | Nanjing Jiangsu, China, The Second Hospital of Nanjing | Nanjing Jiangsu, China, Affiliated Hospital of Nantong University | Nantong Jiangsu, China, The Fifth People's Hospital of Suzhou | Suzhou Jiangsu, China, Wuxi No.5 People's Hospital | Wuxi Jiangsu, China, Third People's Hospital of Zhenjiang | Zhenjiang Jiangsu, China, The First Affiliated Hospital of Nanchang University | Nanchang Jiangxi, China, 330006The Second Affiliated Hospital of Nanchang University | Nanchang Jiangxi, China, First Affiliated Hospital of China Medical University | Shenyang Liaoning, China, The Sixth People' s Hospital Of ShenYang | Shenyang Liaoning, China, Xi'an International Medical Center | Xi'an Shaanxi, China, 710126Xi'an International Medical Center | Xi'an Shaanxi, China, Qilu Hospital of Shandong University | Jinan Shandong, China, 250012Qingdao Central Hospital | Qingdao Shandong, China, Xu, Jun The First Hospital of Shanxi Medical University Taiyun Shanxi | Taiyuan Shanxi, China, The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an Shanxi, China, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chengdu Sichuan Shi, China, The First People's Hospital of Yunnan Province | Kunming Yunnan, China, The First Affiliated Hospital , Zhejiang University School of Medicine | Hangzhou Zhejiang, China, RuiAn People's Hospital - Ruixiang Branch | Ruian Zhejiang, China, The First Affiliated Hospital of Wenzhou Medical University | Wenzhou Zhejiang, China, Yiwu Central Hospital | Yiwu Zhejiang, China, 322000The First Hospital of Jilin University | Changchun , China, Xiangya Hospital - Central South University | Changsha , China, West china hospital Sichuan University | Chengdu , China, The Second Affiliated Hospital of Chongqing Medical University | Chongqing , China, Mengchao Hepatobiliary Hospital of FuJian Medical University | Fuzhou , China, Guangdong Provincial people's hospital | Guangzhou , China, The Third Affiliated Hospital, Sun Yat-Sen University | Guangzhou , China, Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Qingchun Campus | Hangzhou , China, General Hospital of Tianjin Medical University | Heping , China, Ningbo No.2 Hospital (Hwa Mei Hospital) | Ningbo , China, Qingdao Municipal Hospital | Qingdao , China, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai , China, Shengjing Hospital of China Medical University | Shenyang , China, The University of Hong Kong-Shenzhen Hospital | Shenzhen , China, Tianjin Third Central Hospital | Tianjin , China, The First Affiliated Hospital of Zhengzhou University | Zhengzhou , China, Zhengzhou People's Hospital | Zhengzhou , China, Synexus Czech - DRS Prague | Prague , Czechia, 120 00Hôpital de la Croix Rousse | Lyon Auvergne-Rhône-Alpes, France, 69317Hôpital Hautepierre | Strasbourg Bas-Rhin, France, 67200Hôpital Saint-Joseph | Marseille Bouches-du-Rhône, France, 13008CHU Dijon Bourgogne - Hôpital François Mitterrand | Dijon Cantal, France, CHRU de Besançon - Hôpital Jean-Minjoz | Besançon Franche-Comté, France, 25030CHU de Lille - Hôpital Claude Huriez | Lille Hauts-de-France, France, 59037Centre Hospitalier Universitaire de Rennes | Rennes Ille-et-Vilaine, France, 35033Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Isère, France, 38043CHU de Limoges | Limoges Limousin, France, 87042Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec | Nantes Loire Atlantique, France, 44903Hôpitaux de Brabois | Vandœuvre-lès-Nancy Lorraine, France, 54511Hôpitaux de Brabois | Vandœuvre-lès-Nancy Lorraine, France, Centre Hosptitalier Universitaire d'Angers | Angers Maine-et-Loire, France, 49933Centre Hosptitalier Universitaire d'Angers | Angers Maine-et-Loire, France, Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec | Nantes Nantes Cedex 1, France, Hôpital Haut-Lévêque | Pessac New Aquitaine, France, 33604Hôpital Haut-Lévêque | Pessac New Aquitaine, France, CHU Saint-Eloi | Montpellier Occitanie, France, 34295Hôpital Rangueil | Toulouse Occitanie, France, 31059Clinique Pasteur | Toulouse Occitanie, France, 31076Hôpital l'Archet | Nice Provence-Alpes-Côte d'Azur Region, France, 06200Centre Hospitalier Universitaire Estaing | Clermont-Ferrand Puy-de-Dôme, France, 63003Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon | Clichy Île-de-France Region, France, 92118Hôpitaux Universitaires Henri Mondor | Créteil Île-de-France Region, France, 94000Hôpital Universitaire Pitié Salpêtrière | Paris Île-de-France Region, France, 75013Hôpital Saint-Antoine | Paris Île-de-France Region, France, 75571Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse | Villejuif Île-de-France Region, France, 94804St. Josefs-Hospital Wiesbaden | Wiesbaden Hesse, Germany, 65189Universitätsmedizin der Johannes Gutenberg-Universität Mainz | Mainz Rhineland-Palatinate, Germany, 55131Universitätsklinikum des Saarlandes | Homburg Saarland, Germany, 66421Klinikum Chemnitz | Chemnitz Saxony, Germany, 09116Universitätsklinikum Carl Gustav Carus Dresden | Dresden Saxony, Germany, 01307Eugastro | Leipzig Saxony, Germany, 04103Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck Schleswig-Holstein, Germany, EPIMED | Berlin , Germany, 10787Gastroenterologie am Bayerischen Platz | Berlin , Germany, 10825Charité Universitätsmedizin Berlin | Berlin , Germany, 13353Uniklinik Köln | Cologne , Germany, Universitätsklinikum Düsseldorf | Northeim , Germany, SYNEXUS Magyarország Egészségügyi Szolgáltató KFT | Budapest Central Hungary, Hungary, 1036Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen | Debrecen Hajdú-Bihar, Hungary, 4025Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus | Debrecen Hajdú-Bihar, Hungary, 4031MIND Klinika | Budapest , Hungary, 1024High Tech Medical Kft. | Budapest , Hungary, 1064Tel Aviv Sourasky Medical Center | Tel Aviv Gush Dan, Israel, 64239Carmel Medical Center | Haifa Haifa District, Israel, 3436212Shaare Zedek Medical Center | Jerusalem Jerusalem, Israel, 9103102Hadassah University Hospital Ein Kerem | Jerusalem Jerusalem, Israel, 9112001Western Galilee Hospital-Nahariya | Nahariya Northern District, Israel, 22100Soroka Medical Center | Beersheba Southern District, Israel, 84101The Chaim Sheba Medical Center | Ramat Gan Tel Aviv, Israel, 52621Rambam Health Care Campus | Haifa , Israel, 3109601The Chaim Sheba Medical Center | Tel Aviv , Israel, 69710Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo Foggia, Italy, 71013Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan Milan, Italy, 20162Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi | Bologna , Italy, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan , Italy, 20122Università degli Studi di Napoli Federico II | Naples , Italy, Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara | Novara , Italy, 28100Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Palermo , Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma , Italy, UOSD Interdipartimentale Degenza Medica a ciclo breve | Roma , Italy, Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino | Torino , Italy, 10126Centro de Investigacion Medico Biologica y Terapia Avanzada | Guadalajara Jalisco, Mexico, Centro de Investigación y Gastroenterología | Cuauhtémoc Mexico City, Mexico, 06700Organismo Publico Descentralizado Hospital Juarez de Mexico | Mexico City Mexico City, Mexico, 7760PanAmerican Clinical Research Mexico - Cuernavaca | Cuernavaca Morelos, Mexico, Investigaciones Medicas Cisneros | Monterrey Nuevo León, Mexico, 64000Hospital Universitario Doctor José Eleuterio Gonzalez | Monterrey Nuevo León, Mexico, 64460Medical Care and Research S.A. de C.V. | Mérida Yucatán, Mexico, 97070Consultorio de la Dra. Maria Sarai Gonzalez Huezo | Metepec , Mexico, Instituto de Seguridad Social del Estado de Mexico y Municipios | Metepec , Mexico, Oaxaca Site Management Organization S.C. | Metepec , Mexico, Centro de Investigacion y Gastroenterologia, S.C. | Mexico City , Mexico, 03330Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) | Mexico City , Mexico, Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Mexico City , Mexico, Hospital Universitario "Dr. Jose Eleuterio Gonzalez" (Servicio de Gastroenterologia) | Monterrey , Mexico, Hospital Universitario "Dr. José Eleuterio González" (Servicio de Endocrinología) | Monterrey , Mexico, Hospital Universitario Dr. José Eleuterio González | Monterrey , Mexico, Oaxaca Site Management Organization S.C. | Oaxaca City , Mexico, Hospital Regional de Alta Especialidad de Zumpango | Zumpango , Mexico, Elisabeth-TweeSteden Ziekenhuis | Tilburg North Brabant, Netherlands, 5000 LCZiekenhuis Bernhoven | Uden North Brabent, Netherlands, 5400Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum | Amsterdam North Holland, Netherlands, 1081 HVErasmus Medisch Centrum | Rotterdam South Holland, Netherlands, 3015 GDFranciscus Gasthuis & Vlietland | Rotterdam , Netherlands, Universitair Medisch Centrum Utrecht | Utrecht , Netherlands, 3584 CXSynexus - Poznań | Poznan Greater Poland Voivodeship, Poland, 60-702Synexus - Wrocław | Wroclaw Lower Silesian Voivodeship, Poland, 50-381Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych | Wroclaw Lower Silesian Voivodeship, Poland, 51-162Synexus - Warszawa | Warsaw Masovian Voivodeship, Poland, 01-192Synexus - Gdynia | Gdynia Pomeranian Voivodeship, Poland, 81-537Synexus - Częstochowa | Częstochowa Silesian Voivodeship, Poland, 42-202Synexus - Katowice | Katowice Silesian Voivodeship, Poland, 40-040Centrum Medyczne Pratia - Katowice | Katowice Silesian Voivodeship, Poland, 40-081ID Clinic | Mysłowice Silesian Voivodeship, Poland, 41-400Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk , Poland, 80-382Synexus - Łódź | Lodz Łódź Voivodeship, Poland, 90-127Hospital da Senhora da Oliveira - Guimarães | Guimarães Braga District, Portugal, 4835-044Hospital de Braga | Braga , Portugal, 4710-243Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria | Lisbon , Portugal, 1649-035Centro Hospitalar Universitário De São João | Porto , Portugal, 4200-319Hospital Pedro Hispano | Senhora da Hora , Portugal, Senhora Da HoraCentro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. Pedro | Vila Real , Portugal, Galenus Group of Pureto Rico | Manati Pureto Rico, Puerto Rico, 00674Fundación de Investigación de Diego Clinical Research | San Juan , Puerto Rico, 00927Clinresco Centres | Kempton Park Gauteng, South Africa, 1619Synexus Clinical Research SA- Watermeyer | Pretoria Gauteng, South Africa, 184CTN (Clinical Trials Network): Somerset | Cape Town Western Cape, South Africa, 7130Synexus - Mediclinic Southern Africa - Constantiaberg | Cape Town Western Cape, South Africa, 7800Synexus - Helderberg Clinical Research Centre - Somerset West | Somerset West Western Cape, South Africa, 7130Synexus Clinical Research SA- Watermeyer | Pretoria , South Africa, 0184Hospital Universitario Son Espases | Palma de Mallorca Balearic Islands, Spain, 07120Consorci Corporació Sanitària Parc Taulí de Sabadell | Sabadell Barcelona, Spain, 08208Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda Madrid, Spain, 28222Complejo Hospitalario Torrecárdenas | Almería , Spain, 04009Hospital Germans Trias i Pujol | Badalona , Spain, 08916Hospital de la Santa Creu i Sant Pau | Barcelona , Spain, 08025Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital Universitari Vall d'Hebrón | Barcelona , Spain, 08035Hospital Clínic de Barcelona | Barcelona , Spain, 08036Complejo Asistencial Universitario de Leon | León , Spain, 24080Hospital General Universitario Gregorio Marañón | Madrid , Spain, 28007Clínica Universidad de Navarra | Madrid , Spain, 28027Complejo Hospitalario De Pontevedra | Pontevedra , Spain, 36004Hospital Universitario Virgen del Rocío | Seville , Spain, 41011Hospital Clínico Universitario de Valencia | Valencia , Spain, 46010Consorci Hospital General Universitari de València | Valencia , Spain, 46014Hospital Universitario Rio Hortega | Valladolid , Spain, 47012Hospital Clinico Universitario Lozano Blesa | Zaragoza , Spain, 50009Hospital Universitario Miguel Servet | Zaragoza , Spain, 50009Medical Center Medbud-Clinic, LLC | Kyiv , Ukraine, 3037Medical Center Center of Family Medicine Plus, LLC | Kyiv , Ukraine, 4210Barts Health NHS Trust | London England, United Kingdom, E1 1BBPanthera Biopartners - North London | London England, United Kingdom, EN1 1LJKing's College Hospital NHS Foundation Trust | London England, United Kingdom, SE5 9RSPanthera Biopartners - Manchester | Manchester England, United Kingdom, OL11 4AUPanthera Biopartners - Manchester | Manchester England, United Kingdom, The Newcastle Upon Tyne Hospitals NHS Foundation Trust | Newcastle upon Tyne England, United Kingdom, NE7 7DNNottingham University Hospitals NHS Trust | Nottingham England, United Kingdom, Panthera Biopartners - Preston | Preston England, United Kingdom, PR2 9QBSheffield Teaching Hospitals NHS FT | Sheffield England, United Kingdom, Royal Surrey County Hospital NHS Foundation Trust | Surrey Quays England, United Kingdom, GU2 7XXPanthera Biopartners - Glasgow | Glasgow North Lanarkshire, United Kingdom, G51 4TFRoyal Free London NHS Foundation Trust | London , United Kingdom,
Investigators
Principal Investigator: Arun J Sanyal, MD, VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USAPrincipal Investigator: Sven Francque, MD, Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium