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)
NASH - Nonalcoholic Steatohepatitis
About this trial
This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis focused on measuring Phase III, Nonalcoholic Steatohepatitis, NASH, Peroxisome proliferator-activated receptor (PPAR), Liver Diseases, Fibrosis
Eligibility Criteria
Inclusion Criteria:
- 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
Stable 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): Stable dose for at least 3 months
- Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months
- Statins: Stable dose for at least 3 months
- All other chronically administered drugs must be stable 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.
Exclusion Criteria:
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
- 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
- Diabetes mellitus other than type 2
- Current treatment with insulin
Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs])
Obesity related:
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:
- History of heart failure with reduced left ventricular ejection fraction (LVEF)
- Atrial fibrillation requiring anticoagulation
- Unstable heart failure
Uncontrolled hypertension at Screening (values >160/100 mm Hg)
General safety:
- Women currently breastfeeding
- Previous exposure to lanifibranor
- Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer
- Concomitant treatment with PPAR-alpha agonists (fibrates)
Sites / Locations
- Pinnacle Research GroupRecruiting
- Objective Health - Birmingham Gastroenterology AssociatesRecruiting
- Digestive Health Specialist of the SoutheastRecruiting
- North Alabama GI Research Center llcRecruiting
- The Institute For Liver Health - ChandlerRecruiting
- Arizona Liver Health - PeoriaRecruiting
- Saint Joseph's Hospital and Medical CenterRecruiting
- Arizona Digestive Health - Sun CityRecruiting
- Adobe GastroenterologyRecruiting
- Arizona Liver HealthRecruiting
- Del Sol Research Management - Tucson EastRecruiting
- ARcare Center for Clinical Research - ConwayRecruiting
- ARcare Center for Clinical ResearchRecruiting
- Arkansas Diagnostic CenterRecruiting
- Arkansas GastroenterologyRecruiting
- Office of Franco Felizarta, MDRecruiting
- FomatmedicalresearchRecruiting
- Precision Research Institute
- GW ResearchRecruiting
- Velocity Clinical Research, Chula VistaRecruiting
- TriWest Research Associates
- Cure Clinical Research, LLCRecruiting
- SC Clinical Research
- National Research Institute - Santa AnaRecruiting
- The Clinical Trials Network - Gastro Care InstituteRecruiting
- National Research Institute - WestlakeRecruiting
- National Research Institute - Panorama CityRecruiting
- California Liver ReearchRecruiting
- Cadena Care InstituteRecruiting
- Prospective Research Innovations Inc.Recruiting
- Stanford University Medical CenterRecruiting
- Inland Empire Liver FoundationRecruiting
- Research and Education, Inc.Recruiting
- California Pacific Medical Center Research InstituteRecruiting
- Quest Clinical ResearchRecruiting
- Silicon Valley Research InstituteRecruiting
- Clinical Trial Management ServicesRecruiting
- San Fernando Valley Health InstituteRecruiting
- South Denver Gastroenterology - Swedish Medical Center OfficeRecruiting
- Bridgeport HospitalRecruiting
- Yale School of MedicineRecruiting
- MedBio Trials
- Excel Medical Clinical Trials, LLCRecruiting
- Synergy HealthcareRecruiting
- Tampa Bay Medical ResearchRecruiting
- Gastro FloridaRecruiting
- Hi Tech and Global Research, LLCRecruiting
- American Research Institute, INC
- JY Research Institute Inc.
- Top Medical ResearchRecruiting
- Doral Medical Research, LLC
- Palmetto Research
- Florida Research InstituteRecruiting
- Galenus GroupRecruiting
- Accel Research Sites
- Centor for Advanced Gastroenterology - Main Office - Maitland
- Florida Vascular ResearchRecruiting
- Life Medical Research GroupRecruiting
- Optimus U CorporationRecruiting
- Schiff Center for Liver DiseasesRecruiting
- D&H National Research CentersRecruiting
- USPA Advance Concept Medical Research GroupRecruiting
- Future Care SolutionRecruiting
- Genoma Research GroupRecruiting
- Gastro Health - GallowayRecruiting
- Pro Live Medical ResearchRecruiting
- Miami Dade Medical Research InstituteRecruiting
- Clinical Trials Services Corporation
- Advanced Research InstituteRecruiting
- Sensible Healthcare Clinical ResearchRecruiting
- AdventHealth Transplant InstituteRecruiting
- Digestive and Liver Center of Florida - OrlandoRecruiting
- IMIC Research - International Medical Investigations CentersRecruiting
- American Research Centers of FloridaRecruiting
- Pensacola GI Research CenterRecruiting
- Eminat, LLCRecruiting
- NAPA ResearchRecruiting
- Covenant Metabolic Specialists LLC - SarasotaRecruiting
- Tampa General HospitalRecruiting
- GI Alliance - Gastroenterology Associates of Florida - WellingtonRecruiting
- Florida Medical Clinic - ZephyrhillsRecruiting
- Athens Gastroenterology AssociationRecruiting
- Digestive Healthcare of GeorgiaRecruiting
- Research and Education Foundation of Atlanta Medical Center
- Oracle Clinical ResearchRecruiting
- IACT HealthRecruiting
- Southeast Clinical Research CenterRecruiting
- Regional Infectious Diseases and Infusion CenterRecruiting
- Grand Teton Research Group, PLLC
- University of ChicagoRecruiting
- NorthShore University HealthSystemRecruiting
- ASHA Clinical Research - MunsterRecruiting
- Heartland Medical ResearchRecruiting
- University of Iowa Hospitals and ClinicsRecruiting
- Arizona Digestive Health - Sun CityRecruiting
- University of Kansas Medical Center Research InstituteRecruiting
- Kansas Medical Clinic - GastroenterologyRecruiting
- University of KentuckyRecruiting
- Gastroenterology Associates - Baton RougeRecruiting
- Tandem Clinical Research GIRecruiting
- Combined Gastro Research LLCRecruiting
- Tandem Clinical Research
- Metropolitan Gastroenterology Associates - MetairieRecruiting
- Tandem Clinical Research GI, LLCRecruiting
- Louisiana Research Center LLCRecruiting
- Investigative Clinical Research - AnnapolisRecruiting
- Mercy Medical Center - Mcauley PlazaRecruiting
- The Johns Hopkins HospitalRecruiting
- Digestive Disease Associates - Catonsville
- Chevy Chase Clinical ResearchRecruiting
- Gastro Center of Maryland - ColumbiaRecruiting
- Mid-Atlantic GI ResearchRecruiting
- Meritus Center for Clinical Research
- Massachusetts General HospitalRecruiting
- Boston Medical CenterRecruiting
- Beth Israel Deaconess Medical Center - Liver CenterRecruiting
- NECCR Prima Care Research, LLC
- Clinical Research Institute of MichiganRecruiting
- Henry Ford Health SystemRecruiting
- Gastroenterology Associates of Western MichiganRecruiting
- University of Michigan Health-West HospitalRecruiting
- MNGI Digestive Health - Northeast Minneapolis ClinicRecruiting
- Mayo Clinic - RochesterRecruiting
- Gastrointestinal Associates & Endoscopy Center - FlowoodRecruiting
- SKYCRNG - Quinn Healthcare
- Galen ResearchRecruiting
- Gastrointestinal (GI) Associates L.L.P.Recruiting
- Saint Luke's Hospital of Kansas City
- Kansas City Research InstituteRecruiting
- SSM Health Saint Louis University HospitalRecruiting
- Washington University School of Medicine in St. LouisRecruiting
- Southwest Gastroenterology AssociatesRecruiting
- State University of New York - University at BuffaloRecruiting
- Weill Cornell Medical CollegeRecruiting
- Icahn School of Medicine at Mount SinaiRecruiting
- Tandem Clinical Research - New York ClinicRecruiting
- University of Rochester Medical CenterRecruiting
- Richmond University Medical CenterRecruiting
- Charlotte Gastroenterology and Hepatology - Randolph Road OfficeRecruiting
- ObjectiveGI - Northeast GI ResearchRecruiting
- Duke University Medical CenterRecruiting
- Cumberland Research AssociatesRecruiting
- Carolina Digestive Diseases
- Lucas Research, IncRecruiting
- Consultants for Clinical Research - Montgomery OfficeRecruiting
- University Hospitals Case Medical CenterRecruiting
- The Ohio State UniversityRecruiting
- Aventiv Research - ColumbusRecruiting
- Digestive Specialists - DaytonRecruiting
- Great Lakes Gastroenterology Research - MentorRecruiting
- North Shore GastroenterologyRecruiting
- INTEGRIS Baptist Medical CenterRecruiting
- Options Health ResearchRecruiting
- Veterans Affairs Pittsburgh Healthcare System - University Drive CampusRecruiting
- University of Pittsburgh Medical CenterRecruiting
- Medical University of South CarolinaRecruiting
- Palmetto Clinical ResearchRecruiting
- Clinovacare Medical Clinical Research CenterRecruiting
- Rapid City Medical Center
- Gastro One - Germantown Office - Wolf Park DriveRecruiting
- Vanderbilt University Medical CenterRecruiting
- Texas Clinical Research InstituteRecruiting
- Accelemed Research InstituteRecruiting
- Pinnacle Clinical Research - AustinRecruiting
- Gadolin Research
- South Texas Research Institute - BrownsvilleRecruiting
- PanAmerican Clinical Research - US Headquarters
- Velocity Clinical Research - AustinRecruiting
- The Liver Institute at Methodist DallasRecruiting
- Liver Center of TexasRecruiting
- GI Alliance - Texas Digestive Disease Consultants - Fort Worth - DowntownRecruiting
- Soma Clinical TrialsRecruiting
- South Texas Research Institute - EdinburgRecruiting
- Gastro Clinic
- Care United Medical Center - ForneyRecruiting
- Brooke Army Medical CenterRecruiting
- Allure Health, LlcRecruiting
- Digestive Health Associates of Texas - RockwallRecruiting
- Summitt - Pinnacle Clinical Research - GeorgetownRecruiting
- Advanced Medical TrialsRecruiting
- Houston Methodist HospitalRecruiting
- Liver Associates of TexasRecruiting
- Liver Specialists of TexasRecruiting
- Liver Specialists of TexasRecruiting
- Gastroenterology Consultants - EllingtonRecruiting
- Alpha Research Institute, LLCRecruiting
- Houston Research Institute (HRI)Recruiting
- Headlands - Centex Studies - Westfield
- Pioneer Research SolutionsRecruiting
- GI Alliance - Lubbock Digestive Disease Associates - LubbockRecruiting
- GI Alliance - MansfieldRecruiting
- Koncord Research - McAllen LLCRecruiting
- Koncord Research-McAllen LLCRecruiting
- Quality Research - San AntonioRecruiting
- Sun Research InstituteRecruiting
- Texas Liver Institute/American Research CorporationRecruiting
- University of California San DiegoRecruiting
- Pinnacle Clinical Research - San AntonioRecruiting
- Sherman Clinical ResearchRecruiting
- Impact Research InstituteRecruiting
- Digestive Health Research of Central TexasRecruiting
- GI Alliance - Bay Area Gastroenterology - WebsterRecruiting
- Tranquil Clinical ResearchRecruiting
- Digestive Health Research of North TexasRecruiting
- Lone Peak Family HealthRecruiting
- University of Utah School of MedicineRecruiting
- University of Vermont Medical CenterRecruiting
- University of Virginia Health SystemRecruiting
- Gastroenterology Associates of Northern VirginiaRecruiting
- Inova Medical Group - Fairfax HospitalRecruiting
- Emeritas Research Group
- Topography Health, Inc.Recruiting
- Bon Secours Liver Institute of Hampton RoadsRecruiting
- Digestive & Liver Disease SpecialistsRecruiting
- GI Select Health Research, LLCRecruiting
- Virginia Commonwealth UniversityRecruiting
- Liver Institute NorthwestRecruiting
- Froedtert and Medical College of WisconsinRecruiting
- Hospital Italiano de Buenos AiresRecruiting
- Hospital Italiano La PlataRecruiting
- Hospital Universitario AustralRecruiting
- Hospital De Alta Complejidad en Red El CruceRecruiting
- Hospital Provincial del CentenarioRecruiting
- Hospital Británico de Buenos AiresRecruiting
- Concord Repatriation General HospitalRecruiting
- Campbelltown HospitalRecruiting
- Liverpool HospitalRecruiting
- John Hunter HospitalRecruiting
- Nepean HospitalRecruiting
- Gallipoli Medical Research FoundationRecruiting
- Royal Brisbane and Women's HospitalRecruiting
- Eastern Health - AustraliaRecruiting
- Monash Medical CentreRecruiting
- Austin HealthRecruiting
- Fiona Stanley HospitalRecruiting
- Royal Perth HospitalRecruiting
- Medizinische Universität InnsbruckRecruiting
- Universitair Ziekenhuis AntwerpenRecruiting
- Hôpital ErasmeRecruiting
- Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
- Ziekenhuis Oost-Limburg - Campus Sint-JanRecruiting
- Algemeen Ziekenhuis Maria MiddelaresRecruiting
- Universitair Ziekenhuis GentRecruiting
- VitazRecruiting
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-JanRecruiting
- Algemeen Ziekenhuis Delta - Campus RumbekeRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- Centre Hospitalier Universitaire de Liège Site Sart TilmanRecruiting
- Hospital das Clinicas da Universidade Federal de Minas GeraisRecruiting
- Hospital Ernesto DornellesRecruiting
- Hospital de Clínicas de Porto AlegreRecruiting
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloRecruiting
- Hospital das Clínicas da Faculdade de Medicina de Ribeirão PretoRecruiting
- Fundação Faculdade Regional de Medicina de São José do Rio PretoRecruiting
- University Multiprofile Hospital for Active Treatment St. Ivan RilskiRecruiting
- University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. PirogovRecruiting
- Acibadem City Clinic Tokuda HospitalRecruiting
- Diagnostic Consultative Center AleksandrovskaRecruiting
- Diagnostic Consulting Center 20 - Sofia ЕооdRecruiting
- Nov Rehabilitatsionen Tsentar EOOD
- Medical Center Medica PlusRecruiting
- Heritage Medical Research CentreRecruiting
- William Osler Health System - Brampton Civic HospitalRecruiting
- St. Joseph's Healthcare Hamilton - Charlton CampusRecruiting
- University Health NetworkRecruiting
- Toronto Digestive Disease AssociatesRecruiting
- McGill University Health CentreRecruiting
- Centre de Médecine Métabolique de LanaudièreRecruiting
- Hospital San Juan de Dios de La SerenaRecruiting
- Centro De Investigaciones Clínicas Viña Del MarRecruiting
- Pontificia Universidad Católica de Chile - Escuela de MedicinaRecruiting
- Beijing Ditan Hospital, Capital Medical University
- Peking University First Hospital
- Peking University People's Hospital
- Chongqing university three gorges hospital
- First Affiliated Hospital of the Army Military Medical University (Southwest Hospital)
- The First Affiliated Hospital of Chongqing Medical University
- Beijing You'an Hospital,Capital Medical University
- The First Affiliated Hospital of Fujian Medical University
- The First Hospital of Lanzhou University
- Guangzhou First People's Hospital
- Nanfang Hospital of Southern Medical University
- The Eighth Affiliated Hospital,GuangZhou Medical University
- The First Affiliated Hospital Sun Yat-sen University
- The First Affiliated Hospital of Guangxi Medical University
- Guizhou Provincial People's Hospital
- The Affiliated Hospital of Guizhou Medical University
- Fourth Affiliated Hospital of Harbin Medical University
- The First Affiliated Hospital of Henan University of Science and Technology
- The First Affiliated Hospital of Nanyang Medical College
- Sanmenxia Central Hospital
- Henan Provincal People's Hospital
- Zhengzhou First People's Hospital
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Jiangsu Provincial People's Hospital
- The Second Hospital of NanjingRecruiting
- Affiliated Hospital of Nantong University
- The Fifth People's Hospital of Suzhou
- Wuxi No.5 People's Hospital
- Third People's Hospital of Zhenjiang
- The Second Affiliated Hospital of Nanchang University
- First Affiliated Hospital of China Medical University
- The Sixth People' s Hospital Of ShenYang
- Xi'an International Medical Center
- Qingdao Central Hospital
- Xu, Jun The First Hospital of Shanxi Medical University Taiyun Shanxi
- The First Affiliated Hospital of Xi'an Jiaotong University
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
- The Second Hospital of Tianjin Medical University
- The First People's Hospital of Yunnan Province
- The First Affiliated Hospital , Zhejiang University School of Medicine
- RuiAn People's Hospital - Ruixiang Branch
- The First Affiliated Hospital of Wenzhou Medical University
- The First Hospital of Jilin University
- Xiangya Hospital - Central South University
- West china hospital Sichuan University
- The Second Affiliated Hospital of Chongqing Medical University
- Second Affiliated Hospital of Dalian Medical University
- Mengchao Hepatobiliary Hospital of FuJian Medical University
- Guangdong Provincial people's hospital
- The Third Affiliated Hospital, Sun Yat-Sen University
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Qingchun Campus
- General Hospital of Tianjin Medical University
- Ningbo No.2 HospitalRecruiting
- Qingdao Municipal Hospital
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine
- Shengjing Hospital of China Medical University
- The University of Hong Kong-Shenzhen Hospital
- Tianjin Third Central Hospital
- The First Affiliated Hospital of Zhengzhou University
- Zhengzhou People's Hospital
- Research Site s.r.o.Recruiting
- Synexus Czech - DRS PragueRecruiting
- Hôpital HautepierreRecruiting
- Hôpital Saint-JosephRecruiting
- CHU Dijon Bourgogne - Hôpital François MitterrandRecruiting
- CHRU de Besançon - Hôpital Jean-MinjozRecruiting
- CHU de Lille - Hôpital Claude HuriezRecruiting
- Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital BeaujonRecruiting
- Hôpitaux Universitaires Henri MondorRecruiting
- Hôpital Universitaire Pitié SalpêtrièreRecruiting
- Hôpital Saint-AntoineRecruiting
- Hôpitaux Universitaires Paris-Sud - Hôpital Paul BrousseRecruiting
- Centre Hospitalier Universitaire de RennesRecruiting
- Centre Hospitalier Universitaire Grenoble AlpesRecruiting
- CHU de LimogesRecruiting
- Centre Hospitalier Universitaire De Nantes - Hôpital Nord LaennecRecruiting
- Hôpitaux de BraboisRecruiting
- Hôpitaux de BraboisRecruiting
- Centre Hosptitalier Universitaire d'AngersRecruiting
- Centre Hosptitalier Universitaire d'AngersRecruiting
- Centre Hospitalier Universitaire De Nantes - Hôpital Nord LaennecRecruiting
- Hôpital Haut-LévêqueRecruiting
- Hôpital Haut-LévêqueRecruiting
- CHU Saint-EloiRecruiting
- Hôpital RangueilRecruiting
- Clinique PasteurRecruiting
- Hôpital l'ArchetRecruiting
- Centre Hospitalier Universitaire EstaingRecruiting
- Hôpital de la Croix RousseRecruiting
- Hôpital CochinRecruiting
- Klinische Forschung Karlsruhe GmbHRecruiting
- St. Josefs-Hospital WiesbadenRecruiting
- Gastroenterologische Gemeinschaftspraxis HerneRecruiting
- Universitätsmedizin der Johannes Gutenberg-Universität MainzRecruiting
- Universitätsklinikum des SaarlandesRecruiting
- Klinikum ChemnitzRecruiting
- Universitätsklinikum Carl Gustav Carus DresdenRecruiting
- EugastroRecruiting
- Universitätsklinikum Schleswig-Holstein - Campus LübeckRecruiting
- EPIMEDRecruiting
- Gastroenterologie am Bayerischen PlatzRecruiting
- Charité Universitätsmedizin BerlinRecruiting
- Uniklinik KölnRecruiting
- Universitätsklinikum DüsseldorfRecruiting
- SYNEXUS Magyarország Egészségügyi Szolgáltató KFTRecruiting
- Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
- Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus
- MIND KlinikaRecruiting
- High Tech Medical Kft.Recruiting
- Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai IntézetRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- Carmel Medical CenterRecruiting
- Shaare Zedek Medical CenterRecruiting
- Hadassah University Hospital Ein KeremRecruiting
- Western Galilee Hospital-NahariyaRecruiting
- Soroka Medical CenterRecruiting
- The Chaim Sheba Medical CenterRecruiting
- Rambam Health Care CampusRecruiting
- Ospedale Casa Sollievo della SofferenzaRecruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
- Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-MalpighiRecruiting
- Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
- Università degli Studi di Napoli Federico IIRecruiting
- Azienda Ospedaliero-Universitaria Maggiore della Carità di NovaraRecruiting
- Azienda Ospedaliera Universitaria Policlinico Paolo GiacconeRecruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
- UOSD Interdipartimentale Degenza Medica a ciclo breveRecruiting
- Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di TorinoRecruiting
- Centro de Investigación y GastroenterologíaRecruiting
- Centro de Investigacion Medico Biologica y Terapia AvanzadaRecruiting
- PanAmerican Clinical Research Mexico - CuernavacaRecruiting
- Investigaciones Medicas CisnerosRecruiting
- Hospital Universitario Doctor José Eleuterio GonzalezRecruiting
- Medical Care and Research S.A. de C.V.Recruiting
- Medical Care and Research S.A. de C.V.Recruiting
- Centro de Investigacion y Gastroenterologia, S.C.Recruiting
- Consultorio de la Dra. Maria Sarai Gonzalez HuezoRecruiting
- Instituto de Seguridad Social del Estado de Mexico y MunicipiosRecruiting
- Oaxaca Site Management Organization S.C.Recruiting
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.Recruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" (Servicio de Gastroenterologia)Recruiting
- Hospital Universitario "Dr. José Eleuterio González" (Servicio de Endocrinología)Recruiting
- Hospital Universitario Dr. José Eleuterio GonzálezRecruiting
- Hospital Universitario Dr. José Eleuterio GonzálezRecruiting
- Oaxaca Site Management Organization S.C.Recruiting
- PanAmerican Clinical Research S.A. de C.V.Recruiting
- Hospital Regional de Alta Especialidad de ZumpangoRecruiting
- Radboud Universitair Medisch CentrumRecruiting
- Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch CentrumRecruiting
- Elisabeth-TweeSteden ZiekenhuisRecruiting
- Ziekenhuis BernhovenRecruiting
- Erasmus Medisch CentrumRecruiting
- Franciscus Gasthuis & VlietlandRecruiting
- Universitair Medisch Centrum UtrechtRecruiting
- Synexus - WrocławRecruiting
- Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan KlinicznychRecruiting
- Synexus - Warszawa
- Synexus - GdyniaRecruiting
- ID ClinicRecruiting
- Synexus - KatowiceRecruiting
- Centrum Medyczne Pratia - KatowiceRecruiting
- Synexus - PoznańRecruiting
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Synexus - ŁódźRecruiting
- Synexus - CzęstochowaRecruiting
- Hospital da Senhora da Oliveira - GuimarãesRecruiting
- Hospital de BragaRecruiting
- Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa MariaRecruiting
- Centro Hospitalar Universitário De São JoãoRecruiting
- Hospital Pedro HispanoRecruiting
- Unidade Local Saúde Alto Minho - Hospital de Santa LuziaRecruiting
- Centro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. PedroRecruiting
- Fundación de Investigación de Diego Clinical ResearchRecruiting
- Sefako Makgatho Health Sciences University
- Synexus - Mediclinic Southern Africa - Constantiaberg
- Synexus - Helderberg Clinical Research Centre - Somerset WestRecruiting
- Synexus Clinical Research SA- WatermeyerRecruiting
- Hospital Universitario Son EspasesRecruiting
- Consorci Corporació Sanitària Parc Taulí de SabadellRecruiting
- Hospital Universitario Marqués de ValdecillaRecruiting
- Hospital Clínico Universitario de SantiagoRecruiting
- Hospital Universitario Fundación Alcorcón
- Hospital Universitario Puerta de Hierro - MajadahondaRecruiting
- Complejo Hospitalario TorrecárdenasRecruiting
- Hospital Germans Trias i PujolRecruiting
- Hospital de la Santa Creu i Sant PauRecruiting
- Hospital Universitari Vall d'HebrónRecruiting
- Hospital Clínic de BarcelonaRecruiting
- Complejo Asistencial Universitario de LeonRecruiting
- Hospital General Universitario Gregorio MarañónRecruiting
- Clínica Universidad de NavarraRecruiting
- Hospital Universitario Virgen de la VictoriaRecruiting
- Complejo Hospitalario De PontevedraRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Universitario Virgen de ValmeRecruiting
- Hospital Clínico Universitario de ValenciaRecruiting
- Consorci Hospital General Universitari de ValènciaRecruiting
- Hospital Universitario Rio HortegaRecruiting
- Hospital Clinico Universitario Lozano Blesa
- Hospital Universitario Miguel ServetRecruiting
- Medical Center Edelweiss Medics, LLC
- Medical Center Medbud-Clinic, LLC
- Medical Center Center of Family Medicine Plus, LLC
- Barts Health NHS TrustRecruiting
- Panthera Biopartners - North London
- King's College Hospital NHS Foundation TrustRecruiting
- Panthera Biopartners - ManchesterRecruiting
- Panthera Biopartners - ManchesterRecruiting
- The Newcastle Upon Tyne Hospitals NHS Foundation TrustRecruiting
- Nottingham University Hospitals NHS TrustRecruiting
- Panthera Biopartners - Preston
- Sheffield Teaching Hospitals NHS FTRecruiting
- Royal Surrey County Hospital NHS Foundation TrustRecruiting
- Panthera Biopartners - GlasgowRecruiting
- Royal Free London NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Lanifibranor (IVA 337) (800 mg/day)
Lanifibranor (IVA 337) (1200 mg/day)
Matching placebo
2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)
3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)
3 Placebo to match tablets with food --> once a day (quaque die, QD)