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 )
NATiV3
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
1 other identifier
interventional
1,000
24 countries
428
Brief Summary
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2021
Longer than P75 for phase_3
428 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 19, 2021
CompletedStudy Start
First participant enrolled
August 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2026
March 27, 2026
March 1, 2026
5.4 years
April 16, 2021
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Part A: Date of randomisation until the date of biopsy at Week 72
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.
48 weeks after completion of DBPC period
Study Arms (3)
Lanifibranor (IVA 337) (800 mg/day)
EXPERIMENTAL2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --\> once a day (quaque die, QD)
Lanifibranor (IVA 337) (1200 mg/day)
EXPERIMENTAL3 Lanifibranor tablets 400mg with food --\> once a day (quaque die, QD)
Matching placebo
PLACEBO COMPARATOR3 Placebo to match tablets with food --\> once a day (quaque die, QD)
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Male or female, aged ≥18 years at the time of signing informed consent
- Upon central biopsy reading process: diagnosis of NASH according to the Steatosis-Activity-Fibrosis (SAF):
- Steatosis score ≥1
- Activity score: A3 or A4
- Fibrosis score: F2 or F3
- No qualitative change in dose for the drugs listed below:
- 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
- Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
- Statins: for at least 3 months
- No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening
- Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)
- 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.
You may not qualify if:
- Liver-related:
- Documented causes of chronic liver disease other than NASH
- Histologically documented liver cirrhosis (fibrosis stage F4)
- History or current diagnosis of hepatocellular carcinoma (HCC)
- History of or planned liver transplant
- Positive human immunodeficiency virus (HIV) serology
- ALT or AST \>5 × ULN
- AST\<0.6 ULN if the liver biopsy has to be performed in the scope of the study
- Abnormal synthetic liver function as defined by Screening central laboratory evaluation
- Haemoglobin \<110 g/L (11 g/dL) for females and \<120 g/L (12 g/dL) for males
- Patient currently receiving any approved treatment for NASH or obesity
- Current or recent history (\<5 years) of significant alcohol consumption
- 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:
- HbA1c \>9% at Screening
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Inventiva Pharmalead
Study Sites (428)
Objective Health - Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209, United States
Digestive Health Specialist of the Southeast
Dothan, Alabama, 36305, United States
North Alabama GI Research Center llc
Madison, Alabama, 60602, United States
The Institute For Liver Health - Chandler
Chandler, Arizona, 85224-5688, United States
Arizona Liver Health - Peoria
Peoria, Arizona, 85381, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
Adobe Gastroenterology
Tucson, Arizona, 85712, United States
Arizona Liver Health
Tucson, Arizona, 85712, United States
ARcare Center for Clinical Research - Conway
Conway, Arkansas, 72032, United States
ARcare Center for Clinical Research
Little Rock, Arkansas, 72205, United States
Arkansas Diagnostic Center
Little Rock, Arkansas, 72205, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
Fomatmedicalresearch
Camarillo, California, 93011, United States
GW Research
Chula Vista, California, 91910, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911, United States
TriWest Research Associates
El Cajon, California, 92020, United States
Cure Clinical Research, LLC
Fountain Valley, California, 92708, United States
SC Clinical Research
Garden Grove, California, 92844, United States
National Research Institute - Santa Ana
Huntington Park, California, 92704, United States
The Clinical Trials Network - Gastro Care Institute
Lancaster, California, 93534, United States
National Research Institute - Westlake
Los Angeles, California, 90057, United States
National Research Institute - Panorama City
Panorama City, California, 91402, United States
California Liver Reearch
Pasadena, California, 91105, United States
Cadena Care Institute
Poway, California, 92064, United States
Stanford University Medical Center
Redwood City, California, 94063, United States
Research and Education, Inc.
San Diego, California, 92111, United States
California Pacific Medical Center Research Institute
San Francisco, California, 64107, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Silicon Valley Research Institute
San Jose, California, 95128, United States
Clinical Trial Management Services
Thousand Oaks, California, 91360, United States
San Fernando Valley Health Institute
Van Nuys, California, 91405, United States
South Denver Gastroenterology - Swedish Medical Center Office
Englewood, Colorado, 80113, United States
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Synergy Healthcare
Bradenton, Florida, 34208, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Gastro Florida
Clearwater, Florida, 33762, United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134, United States
JY Research Institute Inc.
Cutler Bay, Florida, 33189, United States
Top Medical Research
Cutler Bay, Florida, 33189, United States
Doral Medical Research, LLC
Hialeah, Florida, 33016, United States
Palmetto Research
Hialeah, Florida, 33016, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Galenus Group
Lehigh Acres, Florida, 33936, United States
Accel Research Sites
Maitland, Florida, 32751, United States
Centor for Advanced Gastroenterology - Main Office - Maitland
Maitland, Florida, 32751, United States
Florida Vascular Research
Miami, Florida, 33012, United States
Life Medical Research Group
Miami, Florida, 33122, United States
Schiff Center for Liver Diseases
Miami, Florida, 33136, United States
D&H National Research Centers
Miami, Florida, 33155, United States
Future Care Solution
Miami, Florida, 33165, United States
Genoma Research Group
Miami, Florida, 33165, United States
Gastro Health - Galloway
Miami, Florida, 33173, United States
Pro Live Medical Research
Miami, Florida, 33175, United States
Miami Dade Medical Research Institute
Miami, Florida, 33176, United States
Clinical Trials Services Corporation
Miami, Florida, 33181, United States
Advanced Research Institute
New Port Richey, Florida, 34653, United States
Sensible Healthcare Clinical Research
Ocoee, Florida, 34761, United States
AdventHealth Transplant Institute
Orlando, Florida, 32804, United States
Digestive and Liver Center of Florida - Orlando
Orlando, Florida, 32825, United States
IMIC Research - International Medical Investigations Centers
Palmetto Bay, Florida, 33157, United States
American Research Centers of Florida
Pembroke Pines, Florida, 33027, United States
Pensacola GI Research Center
Pensacola, Florida, 32503, United States
Eminat, LLC
Plantation, Florida, 33317, United States
NAPA Research
Pompano Beach, Florida, 33064, United States
Covenant Metabolic Specialists LLC - Sarasota
Sarasota, Florida, 34420, United States
Tampa General Hospital
Tampa, Florida, 33606, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Florida Medical Clinic - Zephyrhills
Zephyrhills, Florida, 33542, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Oracle Clinical Research
College Park, Georgia, 30349, United States
IACT Health
Columbus, Georgia, 31904, United States
Southeast Clinical Research Center
Dalton, Georgia, 30720, United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60611, United States
NorthShore University HealthSystem
Skokie, Illinois, 60077, United States
ASHA Clinical Research - Munster
Hammond, Indiana, 46324, United States
Heartland Medical Research
Clive, Iowa, 50325, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Arizona Digestive Health - Sun City
Kansas City, Kansas, 66160, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160, United States
Kansas Medical Clinic - Gastroenterology
Topeka, Kansas, 66606, United States
University of Kentucky
Lexington, Kentucky, 40506-0032, United States
Tandem Clinical Research GI
Houma, Louisiana, 70363, United States
Combined Gastro Research LLC
Lafayette, Louisiana, 70503, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Metropolitan Gastroenterology Associates - Metairie
Metairie, Louisiana, 70006, United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71103, United States
Mercy Medical Center - Mcauley Plaza
Baltimore, Maryland, 21202, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Digestive Disease Associates - Catonsville
Catonsville, Maryland, 21228, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Mid-Atlantic GI Research
Greenbelt, Maryland, 20770, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center - Liver Center
Boston, Massachusetts, 02215, United States
NECCR Prima Care Research, LLC
Fall River, Massachusetts, 02721, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519, United States
MNGI Digestive Health - Northeast Minneapolis Clinic
Minneapolis, Minnesota, 55413, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood, Mississippi, 39232, United States
Galen Research
Chesterfield, Missouri, 63005, United States
Gastrointestinal (GI) Associates L.L.P.
Columbia, Missouri, 65201, United States
Kansas City Research Institute
Kansas City, Missouri, 64131, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Sierra Clinical Research - Las Vegas
Las Vegas, Nevada, 89106, United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109, United States
State University of New York - University at Buffalo
Buffalo, New York, 14203, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Tandem Clinical Research - New York Clinic
New York, New York, 10033, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
Charlotte Gastroenterology and Hepatology - Randolph Road Office
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304, United States
Carolina Digestive Diseases
Greenville, North Carolina, 27834, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Gastroenterology of the Piedmont, PA - Salem Office
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research - Montgomery Office
Cincinnati, Ohio, 45249, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
The Ohio State University
Columbus, Ohio, 43201, United States
Aventiv Research - Columbus
Columbus, Ohio, 43213, United States
Digestive Specialists - Dayton
Dayton, Ohio, 45414, United States
Ohio Gastroenterology Group, Inc. - Olentangy Office
Dublin, Ohio, 43016, United States
Great Lakes Gastroenterology Research - Mentor
Mentor, Ohio, 44060, United States
North Shore Gastroenterology
Westlake, Ohio, 44145, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
Veterans Affairs Pittsburgh Healthcare System - University Drive Campus
Pittsburgh, Pennsylvania, 15240, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Palmetto Clinical Research
Summerville, South Carolina, 29485, United States
Clinovacare Medical Clinical Research Center
West Columbia, South Carolina, 29169, United States
Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
Gastro One - Germantown Office - Wolf Park Drive
Germantown, Tennessee, 38138, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Accelemed Research Institute
Austin, Texas, 78745, United States
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520, United States
Velocity Clinical Research - Austin
Cedar Park, Texas, 78613, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203, United States
Liver Center of Texas
Dallas, Texas, 75234, United States
GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown
Dallas, Texas, 75246, United States
Soma Clinical Trials
Denison, Texas, 75020, United States
South Texas Research Institute - Edinburg
Edinburg, Texas, 78539, United States
Care United Medical Center - Forney
Forney, Texas, 75126, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
Digestive Health Associates of Texas - Rockwall
Garland, Texas, 75044, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Liver Associates of Texas
Houston, Texas, 77030, United States
Liver Specialists of Texas
Houston, Texas, 77030, United States
Houston Research Institute (HRI)
Houston, Texas, 77079, United States
Pioneer Research Solutions
Houston, Texas, 77099, United States
GI Alliance - Lubbock Digestive Disease Associates - Lubbock
Lubbock, Texas, 79410, United States
GI Alliance - Mansfield
Mansfield, Texas, 76063, United States
Koncord Research - McAllen LLC
McAllen, Texas, 78504, United States
Koncord Research-McAllen LLC
McAllen, Texas, 78504, United States
Quality Research - San Antonio
San Antonio, Texas, 78209, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Texas Liver Institute/American Research Corporation
San Antonio, Texas, 78215, United States
University of California San Diego
San Antonio, Texas, 78215, United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229, United States
Sherman Clinical Research
Sherman, Texas, 75092, United States
Impact Research Institute
Waco, Texas, 76710, United States
Digestive Health Research of Central Texas
Waco, Texas, 76712, United States
GI Alliance - Bay Area Gastroenterology - Webster
Webster, Texas, 77598, United States
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301, United States
Lone Peak Family Health
Draper, Utah, 84020, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132, United States
University of Vermont Medical Center
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22903, United States
Emeritas Research Group
Leesburg, Virginia, 20176, United States
Topography Health, Inc.
Manassas, Virginia, 20110, United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602, United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, 23502, United States
GI Select Health Research, LLC
Richmond, Virginia, 23236, United States
Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249, United States
Virginia Commonwealth University
Richmond, Virginia, 23284, United States
Liver Institute Northwest
Seattle, Washington, 98105, United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Hospital Británico de Buenos Aires
Buenos Aires, Buenos Aires, C1280AEB, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina
Hospital Italiano La Plata
La Plata, Buenos Aires, B1900AXI, Argentina
Hospital Universitario Austral
Pilar, Buenos Aires, B1629AHJ, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, S2002KDS, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
Campbelltown Hospital
Liverpool, New South Wales, 2170, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Nepean Hospital
Penrith, New South Wales, 2750, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, 4120, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Eastern Health - Australia
Box Hill, Victoria, 3128, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health
Heidelberg, Victoria, 3084, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Universitair Ziekenhuis Antwerpen
Edegem, Antwerpen, 2650, Belgium
Hôpital Erasme
Brussels, Brussels Capital, 1070, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Flemish Brabant, 3000, Belgium
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk, Limburg, 3600, Belgium
Centre Hospitalier Universitaire de Liège Site Sart Tilman
Liège, Liège, B-4000, Belgium
Algemeen Ziekenhuis Maria Middelares
Ghent, Oost-Vlaaderen, 9000, Belgium
Universitair Ziekenhuis Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
Vitaz
Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium
Algemeen Ziekenhuis Delta - Campus Rumbeke
Roeselare, West-Vlaanderen, 8800, Belgium
Hospital das Clinicas da Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130-100, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Cerqueira César, São Paulo, 05403-000, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Ribeirão Preto, São Paulo, 14051-140, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 15090-000, Brazil
Acibadem City Clinic Tokuda Hospital
Sofia, Sofia, 1407, Bulgaria
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia, 1431, Bulgaria
Diagnostic Consulting Center 20 - Sofia Еооd
Sofia, Sofia, 1618, Bulgaria
University Multiprofile Hospital for Active Treatment St. Ivan Rilski
Sofia, Sofia-Grad, 1431, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov
Sofia, Sofia-Grad, 1612, Bulgaria
Medical Center Medica Plus
Veliko Tarnovo, Veliko Tarnovo, 5006, Bulgaria
Heritage Medical Research Centre
Calgary, Alberta, T2N 4Z6, Canada
William Osler Health System - Brampton Civic Hospital
Brampton, Ontario, L6R 3J7, Canada
St. Joseph's Healthcare Hamilton - Charlton Campus
Hamilton, Ontario, L8N 4A6, Canada
University Health Network
Toronto, Ontario, M5G 2C4, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, L4L 4Y7, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
Centre de Médecine Métabolique de Lanaudière
Terrebonne, Quebec, J6X 497, Canada
Hospital San Juan de Dios de La Serena
La Serena, Coquimbo Region, 1700000, Chile
Centro De Investigaciones Clínicas Viña Del Mar
Viña del Mar, Región de Valparaíso, 2540364, Chile
Pontificia Universidad Católica de Chile - Escuela de Medicina
Santiago, Santiago Metropolitan, 8320000, Chile
Beijing 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
The 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
Fourth 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
Henan 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
Jiangsu 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 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
Qingdao 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
The 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, 120 00, Czechia
Hôpital de la Croix Rousse
Lyon, Auvergne-Rhône-Alpes, 69317, France
Hôpital Hautepierre
Strasbourg, Bas-Rhin, 67200, France
Hôpital Saint-Joseph
Marseille, Bouches-du-Rhône, 13008, France
CHU Dijon Bourgogne - Hôpital François Mitterrand
Dijon, Cantal, France
CHRU de Besançon - Hôpital Jean-Minjoz
Besançon, Franche-Comté, 25030, France
CHU de Lille - Hôpital Claude Huriez
Lille, Hauts-de-France, 59037, France
Centre Hospitalier Universitaire de Rennes
Rennes, Ille-et-Vilaine, 35033, France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, Isère, 38043, France
CHU de Limoges
Limoges, Limousin, 87042, France
Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec
Nantes, Loire Atlantique, 44903, France
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, 54511, France
Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Lorraine, France
Centre Hosptitalier Universitaire d'Angers
Angers, Maine-et-Loire, 49933, France
Centre 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, Nouvelle-Aquitaine, 33604, France
Hôpital Haut-Lévêque
Pessac, Nouvelle-Aquitaine, France
CHU Saint-Eloi
Montpellier, Occitanie, 34295, France
Hôpital Rangueil
Toulouse, Occitanie, 31059, France
Clinique Pasteur
Toulouse, Occitanie, 31076, France
Hôpital l'Archet
Nice, Provence-Alpes-Côte d'Azur Region, 06200, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Puy-de-Dôme, 63003, France
Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon
Clichy, Île-de-France Region, 92118, France
Hôpitaux Universitaires Henri Mondor
Créteil, Île-de-France Region, 94000, France
Hôpital Universitaire Pitié Salpêtrière
Paris, Île-de-France Region, 75013, France
Hôpital Saint-Antoine
Paris, Île-de-France Region, 75571, France
Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse
Villejuif, Île-de-France Region, 94804, France
St. Josefs-Hospital Wiesbaden
Wiesbaden, Hesse, 65189, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Universitätsklinikum des Saarlandes
Homburg, Saarland, 66421, Germany
Klinikum Chemnitz
Chemnitz, Saxony, 09116, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Saxony, 01307, Germany
Eugastro
Leipzig, Saxony, 04103, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
EPIMED
Berlin, State of Berlin, 10787, Germany
Gastroenterologie am Bayerischen Platz
Berlin, State of Berlin, 10825, Germany
Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 13353, Germany
Uniklinik Köln
Cologne, Germany
Universitätsklinikum Düsseldorf
Northeim, Germany
MIND Klinika
Budapest, Budapest, 1024, Hungary
SYNEXUS Magyarország Egészségügyi Szolgáltató KFT
Budapest, Central Hungary, 1036, Hungary
Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
Debrecen, Hajdú-Bihar, 4025, Hungary
Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus
Debrecen, Hajdú-Bihar, 4031, Hungary
High Tech Medical Kft.
Budapest, 1064, Hungary
Tel Aviv Sourasky Medical Center
Tel Aviv, Gush Dan, 64239, Israel
Rambam Health Care Campus
Haifa, Haifa District, 3109601, Israel
Carmel Medical Center
Haifa, Haifa District, 3436212, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9103102, Israel
Hadassah University Hospital Ein Kerem
Jerusalem, Jerusalem, 9112001, Israel
Western Galilee Hospital-Nahariya
Nahariya, Northern District, 22100, Israel
Soroka Medical Center
Beersheba, Southern District, 84101, Israel
The Chaim Sheba Medical Center
Ramat Gan, Tel Aviv, 52621, Israel
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, 71013, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milan, 20122, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Milan, 20162, Italy
Università degli Studi di Napoli Federico II
Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Palermo, Palermo, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Roma, Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
Bologna, Italy
Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, 28100, Italy
UOSD Interdipartimentale Degenza Medica a ciclo breve
Roma, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, 10126, Italy
Centro de Investigacion Medico Biologica y Terapia Avanzada
Guadalajara, Jalisco, Mexico
Centro de Investigación y Gastroenterología
Cuauhtémoc, Mexico City, 06700, Mexico
Centro de Investigacion y Gastroenterologia, S.C.
Mexico City, Mexico City, 03330, Mexico
PanAmerican Clinical Research Mexico - Cuernavaca
Cuernavaca, Morelos, Mexico
Investigaciones Medicas Cisneros
Monterrey, Nuevo León, 64000, Mexico
Hospital Universitario Doctor José Eleuterio Gonzalez
Monterrey, Nuevo León, 64460, Mexico
Medical Care and Research S.A. de C.V.
Mérida, Yucatán, 97070, Mexico
Consultorio 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
Instituto 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, 5000 LC, Netherlands
Ziekenhuis Bernhoven
Uden, North Brabent, 5400, Netherlands
Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum
Amsterdam, North Holland, 1081 HV, Netherlands
Erasmus Medisch Centrum
Rotterdam, South Holland, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Utrecht, 3584 CX, Netherlands
Franciscus Gasthuis & Vlietland
Rotterdam, Netherlands
Synexus - Poznań
Poznan, Greater Poland Voivodeship, 60-702, Poland
Synexus - Wrocław
Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych
Wroclaw, Lower Silesian Voivodeship, 51-162, Poland
Synexus - Warszawa
Warsaw, Masovian Voivodeship, 01-192, Poland
Synexus - Gdynia
Gdynia, Pomeranian Voivodeship, 81-537, Poland
Synexus - Częstochowa
Częstochowa, Silesian Voivodeship, 42-202, Poland
Synexus - Katowice
Katowice, Silesian Voivodeship, 40-040, Poland
Centrum Medyczne Pratia - Katowice
Katowice, Silesian Voivodeship, 40-081, Poland
ID Clinic
Mysłowice, Silesian Voivodeship, 41-400, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdansku
Gdansk, 80-382, Poland
Synexus - Łódź
Lodz, Łódź Voivodeship, 90-127, Poland
Hospital de Braga
Braga, Braga District, 4710-243, Portugal
Hospital da Senhora da Oliveira - Guimarães
Guimarães, Braga District, 4835-044, Portugal
Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
Lisbon, Lisbon District, 1649-035, Portugal
Centro Hospitalar Universitário De São João
Porto, Porto District, 4200-319, Portugal
Hospital Pedro Hispano
Senhora da Hora, Senhora Da Hora, Senhora Da Hora, Portugal
Centro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. Pedro
Vila Real, Vila Real District, Portugal
Fundación de Investigación de Diego Clinical Research
San Juan, Puerto Rico, 00927, Puerto Rico
Galenus Group of Pureto Rico
Manatí, Pureto Rico, 00674, Puerto Rico
Synexus Clinical Research SA- Watermeyer
Pretoria, Pretoria, 0184, South Africa
Synexus - Mediclinic Southern Africa - Constantiaberg
Cape Town, Western Cape, 7800, South Africa
Synexus - Helderberg Clinical Research Centre - Somerset West
Somerset West, Western Cape, 7130, South Africa
Complejo Hospitalario Torrecárdenas
Almería, Almería, 04009, Spain
Hospital Germans Trias i Pujol
Badalona, Badalona, 08916, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, 08035, Spain
Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell
Sabadell, Barcelona, 08208, Spain
Complejo Asistencial Universitario de Leon
León, León, 24080, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Madrid, 28007, Spain
Clínica Universidad de Navarra
Madrid, Madrid, 28027, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, 28222, Spain
Complejo Hospitalario De Pontevedra
Pontevedra, Pontevedra, 36004, Spain
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41011, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, 46010, Spain
Consorci Hospital General Universitari de València
Valencia, Valencia, 46014, Spain
Hospital Universitario Rio Hortega
Valladolid, Valladolid, 47012, Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009, Spain
Hospital Universitario Miguel Servet
Zaragoza, Zaragoza, 50009, Spain
Medical Center Medbud-Clinic, LLC
Kyiv, Kyiv Oblast, 3037, Ukraine
Medical Center Center of Family Medicine Plus, LLC
Kyiv, Kyiv Oblast, 4210, Ukraine
Barts Health NHS Trust
London, England, E1 1BB, United Kingdom
Panthera Biopartners - North London
London, England, EN1 1LJ, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS, United Kingdom
Panthera Biopartners - Manchester
Manchester, England, OL11 4AU, United Kingdom
Panthera Biopartners - Manchester
Manchester, England, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, England, NE7 7DN, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, England, United Kingdom
Panthera Biopartners - Preston
Preston, England, PR2 9QB, United Kingdom
Sheffield Teaching Hospitals NHS FT
Sheffield, England, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Surrey Quays, England, GU2 7XX, United Kingdom
Panthera Biopartners - Glasgow
Glasgow, North Lanarkshire, G51 4TF, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arun J Sanyal, MD
VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
- PRINCIPAL INVESTIGATOR
Sven Francque, MD
Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2021
First Posted
April 19, 2021
Study Start
August 19, 2021
Primary Completion (Estimated)
December 30, 2026
Study Completion (Estimated)
December 30, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03