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)

May 18, 2026 updated by: Inventiva Pharma

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

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3

Study Overview

Status

Active, not recruiting

Conditions

NASH - Nonalcoholic Steatohepatitis

Intervention / Treatment

Detailed 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)

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1280AEB
    - Hospital Britanico de Buenos Aires
  - Buenos Aires, Argentina, C1124AAD
    - Hospital De Alta Complejidad en Red El Cruce
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
    - Hospital Italiano de Buenos Aires
  - La Plata, Buenos Aires, Argentina, B1900AXI
    - Hospital Italiano La Plata
  - Pilar, Buenos Aires, Argentina, B1629AHJ
    - Hospital Universitario Austral
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2002KDS
    - Hospital Provincial del Centenario
Australia
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
  - Liverpool, New South Wales, Australia, 2170
    - Campbelltown Hospital
  - Penrith, New South Wales, Australia, 2750
    - Nepean Hospital
- Queensland
  - Greenslopes, Queensland, Australia, 4120
    - Gallipoli Medical Research Foundation
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women's Hospital
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Eastern Health - Australia
  - Clayton, Victoria, Australia, 3168
    - Monash Medical Centre
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital
  - Perth, Western Australia, Australia, 6000
    - Royal Perth Hospital
Belgium
- - Brussels, Belgium, 1200
    - Cliniques Universitaires Saint-luc
  - Liège, Belgium, B-4000
    - Centre Hospitalier Universitaire de Liège Site Sart Tilman
- Antwerpen
  - Edegem, Antwerpen, Belgium, 2650
    - Universitair Ziekenhuis Antwerpen
- Brussels Capital
  - Brussels, Brussels Capital, Belgium, 1070
    - Hôpital Erasme
- Flemish Brabant
  - Leuven, Flemish Brabant, Belgium, 3000
    - Universitair Ziekenhuis Leuven - Campus Gasthuisberg
- Limburg
  - Genk, Limburg, Belgium, 3600
    - Ziekenhuis Oost-Limburg - Campus Sint-Jan
- Oost-Vlaaderen
  - Ghent, Oost-Vlaaderen, Belgium, 9000
    - Algemeen Ziekenhuis Maria Middelares
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - Universitair Ziekenhuis Gent
  - Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
    - Vitaz
- West-Vlaanderen
  - Roeselare, West-Vlaanderen, Belgium, 8800
    - Algemeen Ziekenhuis Delta - Campus Rumbeke
Brazil
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brazil, 30130-100
    - Hospital das Clinicas da Universidade Federal de Minas Gerais
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
- São Paulo
  - Cerqueira César, São Paulo, Brazil, 05403-000
    - Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo
  - Ribeirão Preto, São Paulo, Brazil, 14051-140
    - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto
Bulgaria
- - Sofia, Bulgaria, 1407
    - Acibadem City Clinic Tokuda Hospital
  - Sofia, Bulgaria, 1431
    - Diagnostic Consultative Center Aleksandrovska
  - Sofia, Bulgaria, 1618
    - Diagnostic Consulting Center 20 - Sofia Еооd
  - Veliko Tarnovo, Bulgaria, 5006
    - Medical Center Medica Plus
- Sofia-Grad
  - Sofia, Sofia-Grad, Bulgaria, 1431
    - University Multiprofile Hospital for Active Treatment St. Ivan Rilski
  - Sofia, Sofia-Grad, Bulgaria, 1612
    - University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4Z6
    - Heritage Medical Research Centre
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - William Osler Health System - Brampton Civic Hospital
  - Hamilton, Ontario, Canada, L8N 4A6
    - St. Joseph's Healthcare Hamilton - Charlton Campus
  - Toronto, Ontario, Canada, M5G 2C4
    - University Health Network
  - Vaughan, Ontario, Canada, L4L 4Y7
    - Toronto Digestive Disease Associates
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre
  - Terrebonne, Quebec, Canada, J6X 497
    - Centre de Medecine Metabolique de Lanaudiere
Chile
- - Santiago, Chile, 8320000
    - Pontificia Universidad Católica de Chile - Escuela de Medicina
- Coquimbo Region
  - La Serena, Coquimbo Region, Chile, 1700000
    - Hospital San Juan de Dios de La Serena
- Valparaiso
  - Viña del Mar, Valparaiso, Chile, 2540364
    - Centro de Investigaciones Clinicas Viña del Mar
China
- - Changchun, China
    - The First Hospital of Jilin University
  - Changsha, China
    - Xiangya Hospital - Central South University
  - Chengdu, China
    - West China Hospital Sichuan University
  - Chongqing, China
    - The Second Affiliated Hospital of Chongqing Medical University
  - Fuzhou, China
    - Mengchao Hepatobiliary Hospital of Fujian Medical University
  - Guangzhou, China
    - Guangdong Provincial People's Hospital
  - Guangzhou, China
    - The Third Affiliated Hospital, Sun Yat-sen University
  - Hangzhou, China
    - Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Qingchun Campus
  - Heping, China
    - General Hospital of Tianjin Medical University
  - Ningbo, China
    - Ningbo No.2 Hospital (Hwa Mei Hospital)
  - Qingdao, China
    - Qingdao Municipal Hospital
  - Shanghai, China
    - Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  - Shenyang, China
    - Shengjing Hospital Of China Medical University
  - Shenzhen, China
    - The University of Hong Kong-Shenzhen Hospital
  - Tianjin, China
    - Tianjin Third Central Hospital
  - Zhengzhou, China
    - the First Affiliated Hospital of Zhengzhou University
  - Zhengzhou, China
    - Zhengzhou People's Hospital
- Anhui
  - Hefei, Anhui, China, 230022
    - The First Affiliated Hospital of Anhui Medical University
- Beijing Municipality
  - Beijing, Beijing Municipality, China
    - Peking University People's Hospital
  - Beijing, Beijing Municipality, China
    - Peking University First Hospital
  - Beijing, Beijing Municipality, China
    - Beijing Ditan Hospital, Capital Medical University
  - Beijing, Beijing Municipality, China, 100010
    - Beijing Ditan Hospital Capital Medical University
- Chongging
  - Chongqing, Chongging, China
    - Chongqing University Three Gorges Hospital
  - Chongqing, Chongging, China
    - First Affiliated Hospital of the Army Military Medical University (Southwest Hospital)
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, China
    - The First Affiliated Hospital of Chongqing Medical University
- Fengtai
  - Beijing, Fengtai, China
    - Beijing You'an Hospital,Capital Medical University
- Fujian
  - Fuzhou, Fujian, China
    - The First Affiliated Hospital of Fujian Medical University
- Gansu
  - Lanzhou, Gansu, China
    - The First Hospital of Lanzhou University
- Guangdong
  - Guangzhou, Guangdong, China
    - Guangzhou First People's Hospital
  - Guangzhou, Guangdong, China
    - Nanfang Hospital of Southern Medical University
  - Guangzhou, Guangdong, China
    - The First Affiliated Hospital Sun Yat-sen University
  - Guangzhou, Guangdong, China
    - The Eighth Affiliated Hospital,GuangZhou Medical University
  - Shenzhen, Guangdong, China, 518036
    - Peking University Shenzhen Hospital
- Guangxi
  - Nanning, Guangxi, China
    - The First Affiliated Hospital of Guangxi Medical University
- Guizhou
  - Guiyang, Guizhou, China
    - Guizhou Provincial People's Hospital
  - Guiyang, Guizhou, China
    - The Affiliated Hospital of Guizhou Medical University
- Hebei
  - Shijiazhuang, Hebei, China, 050052
    - The Third Hospital of Hebei Medical University
- Heilongjiang
  - Harbin, Heilongjiang, China, 150036
    - Heilongjiang Provincial Hospital
  - Harbin, Heilongjiang, China
    - Fourth Affiliated Hospital of Harbin Medical University
- Henan
  - Luoyang, Henan, China
    - The First Affiliated Hospital of Henan University of Science and Technology
  - Sanmenxia, Henan, China
    - Sanmenxia Central Hospital
  - Xinxiang, Henan, China, 453000
    - The Third Affiliated Hospital of Xinxiang Medical University
  - Zhengzhou, Henan, China
    - The Sixth People's Hospital of Zhengzhou
  - Zhengzhou, Henan, China
    - Zhengzhou First People's Hospital
  - Zhengzhou, Henan, China
    - Henan Provincal People's Hospital
- Hubei
  - Wuhan, Hubei, China
    - Union Hospital Tongji Medical College Huazhong University of Science and Technology
- Hunan
  - Changsha, Hunan, China, 410699
    - The Second Xiangya Hospital of Central South University
  - Yueyang, Hunan, China, 414000
    - Yue Yang Central Hospital
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Nanjing Drum Tower Hospital
  - Nanjing, Jiangsu, China
    - The Second Hospital of Nanjing
  - Nanjing, Jiangsu, China
    - Jiangsu Provincial People's Hospital
  - Nantong, Jiangsu, China
    - Affiliated Hospital of Nantong University
  - Suzhou, Jiangsu, China
    - The Fifth People's Hospital of Suzhou
  - Wuxi, Jiangsu, China
    - Wuxi No.5 People's Hospital
  - Zhenjiang, Jiangsu, China
    - Third People's Hospital of Zhenjiang
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - The First Affiliated Hospital of Nanchang University
  - Nanchang, Jiangxi, China
    - The Second Affiliated Hospital of Nanchang University
- Liaoning
  - Shenyang, Liaoning, China
    - First Affiliated Hospital of China Medical University
  - Shenyang, Liaoning, China
    - The Sixth People' s Hospital Of ShenYang
- Shaanxi
  - Xi'an, Shaanxi, China
    - Xi'an International Medical Center
  - Xi'an, Shaanxi, China, 710126
    - Xi'an International Medical Center
- Shandong
  - Jinan, Shandong, China, 250012
    - Qilu Hospital of Shandong University
  - Qingdao, Shandong, China
    - Qingdao Central Hospital
- Shanxi
  - Taiyuan, Shanxi, China
    - Xu, Jun The First Hospital of Shanxi Medical University Taiyun Shanxi
  - Xi’an, Shanxi, China
    - The First Affiliated Hospital Of Xi'an Jiaotong University
- Sichuan Shi
  - Chengdu, Sichuan Shi, China
    - Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
- Yunnan
  - Kunming, Yunnan, China
    - The First People's Hospital of Yunnan Province
- Zhejiang
  - Hangzhou, Zhejiang, China
    - The First Affiliated Hospital , Zhejiang University School of Medicine
  - Ruian, Zhejiang, China
    - RuiAn People's Hospital - Ruixiang Branch
  - Wenzhou, Zhejiang, China
    - The First Affiliated Hospital of Wenzhou Medical University
  - Yiwu, Zhejiang, China, 322000
    - Yiwu Central Hospital
Czechia
- - Prague, Czechia, 120 00
    - Synexus Czech - DRS Prague
France
- Auvergne-Rhône-Alpes
  - Lyon, Auvergne-Rhône-Alpes, France, 69317
    - Hôpital de la Croix Rousse
- Bas-Rhin
  - Strasbourg, Bas-Rhin, France, 67200
    - Hôpital Hautepierre
- Bouches-du-Rhône
  - Marseille, Bouches-du-Rhône, France, 13008
    - Hôpital Saint-Joseph
- Cantal
  - Dijon, Cantal, France
    - CHU Dijon Bourgogne - Hôpital François Mitterrand
- Franche-Comté
  - Besançon, Franche-Comté, France, 25030
    - CHRU de Besançon - Hôpital Jean-Minjoz
- Hauts-de-France
  - Lille, Hauts-de-France, France, 59037
    - CHU de LILLE - Hopital Claude Huriez
- Ille-et-Vilaine
  - Rennes, Ille-et-Vilaine, France, 35033
    - Centre Hospitalier Universitaire de Rennes
- Isère
  - Grenoble, Isère, France, 38043
    - Centre Hospitalier Universitaire Grenoble Alpes
- Limousin
  - Limoges, Limousin, France, 87042
    - CHU de Limoges
- Loire Atlantique
  - Nantes, Loire Atlantique, France, 44903
    - Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
- Lorraine
  - Vandœuvre-lès-Nancy, Lorraine, France, 54511
    - Hopitaux de Brabois
  - Vandœuvre-lès-Nancy, Lorraine, France
    - Hopitaux de Brabois
- Maine-et-Loire
  - Angers, Maine-et-Loire, France, 49933
    - Centre Hosptitalier Universitaire d'Angers
  - Angers, Maine-et-Loire, France
    - Centre Hosptitalier Universitaire d'Angers
- Nantes Cedex 1
  - Nantes, Nantes Cedex 1, France
    - Centre Hospitalier Universitaire de Nantes - Hopital Nord Laennec
- New Aquitaine
  - Pessac, New Aquitaine, France, 33604
    - Hôpital Haut-Lévêque
  - Pessac, New Aquitaine, France
    - Hôpital Haut-Lévêque
- Occitanie
  - Montpellier, Occitanie, France, 34295
    - CHU Saint-Eloi
  - Toulouse, Occitanie, France, 31059
    - Hôpital Rangueil
  - Toulouse, Occitanie, France, 31076
    - Clinique Pasteur
- Provence-Alpes-Côte d'Azur Region
  - Nice, Provence-Alpes-Côte d'Azur Region, France, 06200
    - Hôpital l'Archet
- Puy-de-Dôme
  - Clermont-Ferrand, Puy-de-Dôme, France, 63003
    - Centre Hospitalier Universitaire Estaing
- Île-de-France Region
  - Clichy, Île-de-France Region, France, 92118
    - Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon
  - Créteil, Île-de-France Region, France, 94000
    - Hôpitaux Universitaires Henri Mondor
  - Paris, Île-de-France Region, France, 75013
    - Hôpital Universitaire Pitié Salpêtrière
  - Paris, Île-de-France Region, France, 75571
    - Hôpital Saint-Antoine
  - Villejuif, Île-de-France Region, France, 94804
    - Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse
Germany
- - Berlin, Germany, 13353
    - Charité Universitätsmedizin Berlin
  - Berlin, Germany, 10825
    - Gastroenterologie am Bayerischen Platz
  - Berlin, Germany, 10787
    - EPIMED
  - Cologne, Germany
    - Uniklinik Koln
  - Northeim, Germany
    - Universitätsklinikum Düsseldorf
- Hesse
  - Wiesbaden, Hesse, Germany, 65189
    - St. Josefs-Hospital Wiesbaden
- Rhineland-Palatinate
  - Mainz, Rhineland-Palatinate, Germany, 55131
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Saarland
  - Homburg, Saarland, Germany, 66421
    - Universitatsklinikum des Saarlandes
- Saxony
  - Chemnitz, Saxony, Germany, 09116
    - Klinikum Chemnitz
  - Dresden, Saxony, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus Dresden
  - Leipzig, Saxony, Germany, 04103
    - EUGASTRO
- Schleswig-Holstein
  - Lübeck, Schleswig-Holstein, Germany
    - Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Hungary
- - Budapest, Hungary, 1064
    - High Tech Medical Kft.
  - Budapest, Hungary, 1024
    - MIND Klinika
- Central Hungary
  - Budapest, Central Hungary, Hungary, 1036
    - SYNEXUS Magyarország Egészségügyi Szolgáltató KFT
- Hajdú-Bihar
  - Debrecen, Hajdú-Bihar, Hungary, 4031
    - Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus
  - Debrecen, Hajdú-Bihar, Hungary, 4025
    - Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
Israel
- - Haifa, Israel, 3109601
    - Rambam Health Care Campus
  - Tel Aviv, Israel, 69710
    - The Chaim Sheba Medical Center
- Gush Dan
  - Tel Aviv, Gush Dan, Israel, 64239
    - Tel Aviv Sourasky Medical Center
- Haifa District
  - Haifa, Haifa District, Israel, 3436212
    - Carmel Medical Center
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 9103102
    - Shaare Zedek Medical Center
  - Jerusalem, Jerusalem, Israel, 9112001
    - Hadassah University Hospital Ein Kerem
- Northern District
  - Nahariya, Northern District, Israel, 22100
    - Western Galilee Hospital-Nahariya
- Southern District
  - Beersheba, Southern District, Israel, 84101
    - Soroka Medical Center
- Tel Aviv
  - Ramat Gan, Tel Aviv, Israel, 52621
    - The Chaim Sheba Medical Center
Italy
- - Bologna, Italy
    - Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
  - Milan, Italy, 20122
    - Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
  - Naples, Italy
    - Università degli Studi di Napoli Federico II
  - Novara, Italy, 28100
    - Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
  - Palermo, Italy
    - Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
  - Roma, Italy
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  - Roma, Italy
    - UOSD Interdipartimentale Degenza Medica a ciclo breve
  - Torino, Italy, 10126
    - Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - Ospedale Casa Sollievo della Sofferenza
- Milan
  - Milan, Milan, Italy, 20162
    - Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Mexico
- - Metepec, 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.
  - Mexico City, 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, 03330
    - Centro de Investigacion y Gastroenterologia, S.C.
  - Monterrey, Mexico
    - Hospital Universitario Dr. Jose Eleuterio Gonzalez
  - Monterrey, Mexico
    - Hospital Universitario "Dr. Jose Eleuterio Gonzalez" (Servicio de Gastroenterologia)
  - Monterrey, Mexico
    - Hospital Universitario "Dr. José Eleuterio González" (Servicio de Endocrinología)
  - Oaxaca City, Mexico
    - Oaxaca Site Management Organization S.C.
  - Zumpango, Mexico
    - Hospital Regional de Alta Especialidad de Zumpango
- Jalisco
  - Guadalajara, Jalisco, Mexico
    - Centro de Investigacion Medico Biologica y Terapia Avanzada
- Mexico City
  - Cuauhtémoc, Mexico City, Mexico, 06700
    - Centro de Investigacion y Gastroenterologia
  - Mexico City, Mexico City, Mexico, 7760
    - Organismo Publico Descentralizado Hospital Juarez de Mexico
- Morelos
  - Cuernavaca, Morelos, Mexico
    - PanAmerican Clinical Research Mexico - Cuernavaca
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Hospital Universitario Doctor José Eleuterio Gonzalez
  - Monterrey, Nuevo León, Mexico, 64000
    - Investigaciones Médicas Cisneros
- Yucatán
  - Mérida, Yucatán, Mexico, 97070
    - Medical Care and Research S.A. de C.V.
Netherlands
- - Rotterdam, Netherlands
    - Franciscus Gasthuis & Vlietland
  - Utrecht, Netherlands, 3584 CX
    - Universitair Medisch Centrum Utrecht
- North Brabant
  - Tilburg, North Brabant, Netherlands, 5000 LC
    - Elisabeth-TweeSteden Ziekenhuis
- North Brabent
  - Uden, North Brabent, Netherlands, 5400
    - Ziekenhuis Bernhoven
- North Holland
  - Amsterdam, North Holland, Netherlands, 1081 HV
    - Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum
- South Holland
  - Rotterdam, South Holland, Netherlands, 3015 GD
    - Erasmus Medisch Centrum
Poland
- - Gdansk, Poland, 80-382
    - Synexus Polska Sp. z o.o. Oddzial w Gdansku
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 60-702
    - Synexus - Poznań
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Poland, 50-381
    - Synexus - Wrocław
  - Wroclaw, Lower Silesian Voivodeship, Poland, 51-162
    - Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 01-192
    - Synexus - Warszawa
- Pomeranian Voivodeship
  - Gdynia, Pomeranian Voivodeship, Poland, 81-537
    - Synexus - Gdynia
- Silesian Voivodeship
  - Częstochowa, Silesian Voivodeship, Poland, 42-202
    - Synexus - Częstochowa
  - Katowice, Silesian Voivodeship, Poland, 40-040
    - Synexus - Katowice
  - Katowice, Silesian Voivodeship, Poland, 40-081
    - Centrum Medyczne Pratia - Katowice
  - Mysłowice, Silesian Voivodeship, Poland, 41-400
    - ID Clinic
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 90-127
    - Synexus - Łódź
Portugal
- - Braga, Portugal, 4710-243
    - Hospital de Braga
  - Lisbon, Portugal, 1649-035
    - Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
  - Porto, Portugal, 4200-319
    - Centro Hospitalar Universitario de Sao Joao
  - Senhora da Hora, Portugal, Senhora Da Hora
    - Hospital Pedro Hispano
  - Vila Real, Portugal
    - Centro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. Pedro
- Braga District
  - Guimarães, Braga District, Portugal, 4835-044
    - Hospital da Senhora da Oliveira - Guimarães
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Fundación de Investigación de Diego Clinical Research
- Pureto Rico
  - Manati, Pureto Rico, Puerto Rico, 00674
    - Galenus Group of Pureto Rico
South Africa
- - Pretoria, South Africa, 0184
    - Synexus Clinical Research SA- Watermeyer
- Gauteng
  - Kempton Park, Gauteng, South Africa, 1619
    - Clinresco Centres
  - Pretoria, Gauteng, South Africa, 184
    - Synexus Clinical Research SA- Watermeyer
- Western Cape
  - Cape Town, Western Cape, South Africa, 7800
    - Synexus - Mediclinic Southern Africa - Constantiaberg
  - Cape Town, Western Cape, South Africa, 7130
    - CTN (Clinical Trials Network): Somerset
  - Somerset West, Western Cape, South Africa, 7130
    - Synexus - Helderberg Clinical Research Centre - Somerset West
Spain
- - Almería, Spain, 04009
    - Complejo Hospitalario Torrecárdenas
  - Badalona, Spain, 08916
    - Hospital Germans Trias i Pujol
  - Barcelona, Spain, 08036
    - Hospital Clinic De Barcelona
  - Barcelona, Spain, 08025
    - Hospital De La Santa Creu I Sant Pau
  - Barcelona, Spain, 08035
    - Hospital Universitari Vall d'Hebron
  - León, Spain, 24080
    - Complejo Asistencial Universitario de Leon
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28027
    - Clinica Universidad de Navarra
  - Pontevedra, Spain, 36004
    - Complejo Hospitalario de Pontevedra
  - Seville, Spain, 41011
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46014
    - Consorci Hospital General Universitari de València
  - Valladolid, Spain, 47012
    - Hospital Universitario Río Hortega
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
- Balearic Islands
  - Palma de Mallorca, Balearic Islands, Spain, 07120
    - Hospital Universitario Son Espases
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Consorci Corporació Sanitària Parc Taulí de Sabadell
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Majadahonda
Ukraine
- - Kyiv, Ukraine, 3037
    - Medical Center Medbud-Clinic, LLC
  - Kyiv, Ukraine, 4210
    - Medical Center Center of Family Medicine Plus, LLC
United Kingdom
- - London, United Kingdom
    - Royal Free London NHS Foundation Trust
- England
  - London, England, United Kingdom, SE5 9RS
    - King's College Hospital NHS Foundation Trust
  - London, England, United Kingdom, E1 1BB
    - Barts Health NHS Trust
  - London, England, United Kingdom, EN1 1LJ
    - Panthera Biopartners - North London
  - Manchester, England, United Kingdom, OL11 4AU
    - Panthera Biopartners - Manchester
  - Manchester, England, United Kingdom
    - Panthera Biopartners - Manchester
  - Newcastle upon Tyne, England, United Kingdom, NE7 7DN
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
  - Nottingham, England, United Kingdom
    - Nottingham University Hospitals Nhs Trust
  - Preston, England, United Kingdom, PR2 9QB
    - Panthera Biopartners - Preston
  - Sheffield, England, United Kingdom
    - Sheffield Teaching Hospitals NHS FT
  - Surrey Quays, England, United Kingdom, GU2 7XX
    - Royal Surrey County Hospital NHS Foundation Trust
- North Lanarkshire
  - Glasgow, North Lanarkshire, United Kingdom, G51 4TF
    - Panthera Biopartners - Glasgow
United States
- Alabama
  - Birmingham, Alabama, United States, 35209
    - Objective Health - Birmingham Gastroenterology Associates
  - Dothan, Alabama, United States, 36305
    - Digestive Health Specialist of the Southeast
  - Madison, Alabama, United States, 60602
    - North Alabama GI Research Center llc
- Arizona
  - Chandler, Arizona, United States, 85224-5688
    - The Institute for Liver Health - Chandler
  - Peoria, Arizona, United States, 85381
    - Arizona Liver Health - Peoria
  - Phoenix, Arizona, United States, 85013
    - Saint Joseph's Hospital and Medical Center
  - Phoenix, Arizona, United States, 85013
    - Dignity Health - St. Joseph's Hospital and Medical Center
  - Tucson, Arizona, United States, 85712
    - Adobe Gastroenterology
  - Tucson, Arizona, United States, 85712
    - Arizona Liver Health
- Arkansas
  - Conway, Arkansas, United States, 72032
    - ARcare Center for Clinical Research - Conway
  - Little Rock, Arkansas, United States, 72205
    - Arkansas Diagnostic Center
  - Little Rock, Arkansas, United States, 72205
    - ARcare Center for Clinical Research
  - North Little Rock, Arkansas, United States, 72117
    - Arkansas Gastroenterology
  - North Little Rock, Arkansas, United States, 72117
    - Summit - Arkansas Gastroenterology
- California
  - Camarillo, California, United States, 93011
    - Fomatmedicalresearch
  - Chula Vista, California, United States, 91911
    - Velocity Clinical Research, Chula Vista
  - Chula Vista, California, United States, 91910
    - GW Research
  - El Cajon, California, United States, 92020
    - TriWest Research Associates
  - Fountain Valley, California, United States, 92708
    - Cure Clinical Research, LLC
  - Garden Grove, California, United States, 92844
    - SC Clinical Research
  - Gardena, California, United States, 90247
    - Velocity Clinical Research - Gardena
  - Huntington Park, California, United States, 92704
    - National Research Institute - Santa Ana
  - Lancaster, California, United States, 93534
    - The Clinical Trials Network - Gastro Care Institute
  - Los Angeles, California, United States, 90057
    - National Research Institute - Westlake
  - Panorama City, California, United States, 91402
    - National Research Institute - Panorama City
  - Pasadena, California, United States, 91105
    - California Liver Reearch
  - Poway, California, United States, 92064
    - Cadena Care Institute
  - Redwood City, California, United States, 94063
    - Stanford University Medical Center
  - San Diego, California, United States, 92111
    - Research and Education, Inc.
  - San Francisco, California, United States, 94115
    - Quest Clinical Research
  - San Francisco, California, United States, 64107
    - California Pacific Medical Center Research Institute
  - San Jose, California, United States, 95128
    - Silicon Valley Research Institute
  - Thousand Oaks, California, United States, 91360
    - Clinical Trial Management Services
  - Van Nuys, California, United States, 91405
    - San Fernando Valley Health Institute
- Colorado
  - Englewood, Colorado, United States, 80113
    - South Denver Gastroenterology - Swedish Medical Center Office
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale School of Medicine
- Florida
  - Bradenton, Florida, United States, 34208
    - Synergy Healthcare
  - Bradenton, Florida, United States, 34209
    - Florida Research Institute
  - Clearwater, Florida, United States, 33761
    - Tampa Bay Medical Research
  - Clearwater, Florida, United States, 33762
    - Gastro Florida
  - Coral Gables, Florida, United States, 33134
    - Hi Tech and Global Research, LLC
  - Cutler Bay, Florida, United States, 33189
    - Top Medical Research
  - Cutler Bay, Florida, United States, 33189
    - JY Research Institute Inc.
  - Hialeah, Florida, United States, 33016
    - Palmetto Research
  - Hialeah, Florida, United States, 33016
    - Doral Medical Research, LLC
  - Lakewood Rch, Florida, United States, 34211
    - Florida Research Institute
  - Lehigh Acres, Florida, United States, 33936
    - Galenus Group
  - Maitland, Florida, United States, 32751
    - Accel Research Sites
  - Maitland, Florida, United States, 32751
    - Centor for Advanced Gastroenterology - Main Office - Maitland
  - Miami, Florida, United States, 33176
    - Miami Dade Medical Research Institute
  - Miami, Florida, United States, 33136
    - Schiff Center for Liver Diseases
  - Miami, Florida, United States, 33165
    - Genoma Research Group
  - Miami, Florida, United States, 33165
    - Future Care Solution
  - Miami, Florida, United States, 33155
    - D&H National Research Centers
  - Miami, Florida, United States, 33175
    - Pro Live Medical Research
  - Miami, Florida, United States, 33012
    - Florida Vascular Research
  - Miami, Florida, United States, 33122
    - Life Medical Research Group
  - Miami, Florida, United States, 33173
    - Gastro Health - Galloway
  - Miami, Florida, United States, 33181
    - Clinical Trials Services Corporation
  - New Port Richey, Florida, United States, 34653
    - Advanced Research Institute
  - Ocoee, Florida, United States, 34761
    - Sensible Healthcare Clinical Research
  - Orlando, Florida, United States, 32804
    - AdventHealth Transplant Institute
  - Orlando, Florida, United States, 32825
    - Digestive and Liver Center of Florida - Orlando
  - Palmetto Bay, Florida, United States, 33157
    - IMIC Research - International Medical Investigations Centers
  - Pembroke Pines, Florida, United States, 33027
    - American Research Centers of Florida
  - Pensacola, Florida, United States, 32503
    - Pensacola GI Research Center
  - Plantation, Florida, United States, 33317
    - Eminat, LLC
  - Pompano Beach, Florida, United States, 33064
    - NAPA Research
  - Pompano Beach, Florida, United States, 33064
    - D & H Pompano Research Center
  - Sarasota, Florida, United States, 34420
    - Covenant Metabolic Specialists LLC - Sarasota
  - Tampa, Florida, United States, 33606
    - Tampa General Hospital
  - Weston, Florida, United States, 33331
    - Cleveland Clinic Florida
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic - Zephyrhills
- Georgia
  - Atlanta, Georgia, United States, 30309
    - Digestive Healthcare of Georgia
  - College Park, Georgia, United States, 30349
    - Oracle Clinical Research
  - Columbus, Georgia, United States, 31904
    - IACT Health
  - Dalton, Georgia, United States, 30720
    - Southeast Clinical Research Center
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Grand Teton Research Group, PLLC
- Illinois
  - Chicago, Illinois, United States, 60611
    - Northwestern University
  - Chicago, Illinois, United States, 60611
    - University of Chicago
  - Skokie, Illinois, United States, 60077
    - Northshore University Healthsystem
- Indiana
  - Hammond, Indiana, United States, 46324
    - ASHA Clinical Research - Munster
- Iowa
  - Clive, Iowa, United States, 50325
    - Heartland Medical Research
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Medical Center Research Institute
  - Kansas City, Kansas, United States, 66160
    - Arizona Digestive Health - Sun City
  - Topeka, Kansas, United States, 66606
    - Kansas Medical Clinic - Gastroenterology
- Kentucky
  - Lexington, Kentucky, United States, 40506-0032
    - University Of Kentucky
- Louisiana
  - Houma, Louisiana, United States, 70363
    - Tandem Clinical Research GI
  - Lafayette, Louisiana, United States, 70503
    - Combined Gastro Research LLC
  - Marrero, Louisiana, United States, 70072
    - Tandem Clinical Research
  - Metairie, Louisiana, United States, 70006
    - Metropolitan Gastroenterology Associates - Metairie
  - Shreveport, Louisiana, United States, 71103
    - Louisiana Research Center LLC
- Maryland
  - Baltimore, Maryland, United States, 21287
    - The Johns Hopkins Hospital
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center - Mcauley Plaza
  - Catonsville, Maryland, United States, 21228
    - Digestive Disease Associates - Catonsville
  - Chevy Chase, Maryland, United States, 20815
    - Chevy Chase Clinical Research
  - Greenbelt, Maryland, United States, 20770
    - Mid-Atlantic GI Research
  - Hagerstown, Maryland, United States, 21742
    - Meritus Center for Clinical Research
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Massachusetts General Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Boston, Massachusetts, United States, 02215
    - Beth Israel Deaconess Medical Center - Liver Center
  - Fall River, Massachusetts, United States, 02721
    - NECCR Prima Care Research, LLC
- Michigan
  - Chesterfield, Michigan, United States, 48047
    - Clinical Research Institute of Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System
  - Wyoming, Michigan, United States, 49519
    - Gastroenterology Associates of Western Michigan
- Minnesota
  - Minneapolis, Minnesota, United States, 55413
    - MNGI Digestive Health - Northeast Minneapolis Clinic
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic - Rochester
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Gastrointestinal Associates & Endoscopy Center - Flowood
- Missouri
  - Chesterfield, Missouri, United States, 63005
    - Galen Research
  - Columbia, Missouri, United States, 65201
    - Gastrointestinal (GI) Associates L.L.P.
  - Kansas City, Missouri, United States, 64131
    - Kansas City Research Institute
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine in St. Louis
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Sierra Clinical Research - Las Vegas
- New Mexico
  - Albuquerque, New Mexico, United States, 87109
    - Southwest Gastroenterology Associates
- New York
  - Buffalo, New York, United States, 14203
    - State University of New York - University at Buffalo
  - New York, New York, United States, 10029
    - Icahn School Of Medicine At Mount Sinai
  - New York, New York, United States, 10021
    - Weill Cornell Medical College
  - New York, New York, United States, 10033
    - Tandem Clinical Research - New York Clinic
  - New York, New York, United States, 10016
    - New York University Langone Gastroenterology Associates
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center
  - Staten Island, New York, United States, 10310
    - Richmond University Medical Center
- North Carolina
  - Charlotte, North Carolina, United States, 28207
    - Charlotte Gastroenterology and Hepatology - Randolph Road Office
  - Durham, North Carolina, United States, 27710
    - Duke University Medical Center
  - Durham, North Carolina, United States, 27710
    - Icahn School Of Medicine At Mount Sinai
  - Fayetteville, North Carolina, United States, 28304
    - Cumberland Research Associates
  - Greenville, North Carolina, United States, 27834
    - Carolina Digestive Diseases
  - Morehead City, North Carolina, United States, 28557
    - Lucas Research, Inc
  - Winston-Salem, North Carolina, United States, 27103
    - Gastroenterology of the Piedmont, PA - Salem Office
- Ohio
  - Cincinnati, Ohio, United States, 45249
    - Consultants for Clinical Research - Montgomery Office
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Case Medical Center
  - Columbus, Ohio, United States, 43201
    - The Ohio State University
  - Columbus, Ohio, United States, 43213
    - Aventiv Research - Columbus
  - Columbus, Ohio, United States, 43213
    - Centricity (Aventiv) Research - Columbus
  - Dayton, Ohio, United States, 45414
    - Digestive Specialists - Dayton
  - Dublin, Ohio, United States, 43016
    - Ohio Gastroenterology Group, Inc. - Olentangy Office
  - Mentor, Ohio, United States, 44060
    - Great Lakes Gastroenterology Research - Mentor
  - Westlake, Ohio, United States, 44145
    - North Shore Gastroenterology
- Oklahoma
  - Tulsa, Oklahoma, United States, 74104
    - Options Health Research
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15261
    - University of Pittsburgh Medical Center
  - Pittsburgh, Pennsylvania, United States, 15240
    - Veterans Affairs Pittsburgh Healthcare System - University Drive Campus
- South Carolina
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Summerville, South Carolina, United States, 29485
    - Palmetto Clinical Research
  - West Columbia, South Carolina, United States, 29169
    - Clinovacare Medical Clinical Research Center
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Medical Center
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Gastro One - Germantown Office - Wolf Park Drive
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center
- Texas
  - Arlington, Texas, United States, 76012
    - Texas Clinical Research Institute
  - Austin, Texas, United States, 78745
    - Accelemed Research Institute
  - Brownsville, Texas, United States, 78520
    - South Texas Research Institute - Brownsville
  - Cedar Park, Texas, United States, 78613
    - Velocity Clinical Research - Austin
  - Dallas, Texas, United States, 75203
    - The Liver Institute At Methodist Dallas
  - Dallas, Texas, United States, 75234
    - Liver Center of Texas
  - Dallas, Texas, United States, 75246
    - GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown
  - Denison, Texas, United States, 75020
    - Soma Clinical Trials
  - Edinburg, Texas, United States, 78539
    - South Texas Research Institute - Edinburg
  - Forney, Texas, United States, 75126
    - Care United Medical Center - Forney
  - Fort Sam Houston, Texas, United States, 78234
    - Brooke Army Medical Center
  - Garland, Texas, United States, 75044
    - Digestive Health Associates of Texas - Rockwall
  - Houston, Texas, United States, 77030
    - Houston Methodist Hospital
  - Houston, Texas, United States, 77030
    - Liver Associates of Texas
  - Houston, Texas, United States, 77099
    - Pioneer Research Solutions
  - Houston, Texas, United States, 77030
    - Liver Specialists of Texas
  - Houston, Texas, United States, 77079
    - Houston Research Institute (HRI)
  - Live Oak, Texas, United States, 78233
    - Summit - Pinnacle Clinical Research - Austin
  - Lubbock, Texas, United States, 79410
    - GI Alliance - Lubbock Digestive Disease Associates - Lubbock
  - Mansfield, Texas, United States, 76063
    - GI Alliance - Mansfield
  - McAllen, Texas, United States, 78504
    - Koncord Research - McAllen LLC
  - McAllen, Texas, United States, 78504
    - Koncord Research-McAllen LLC
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute
  - San Antonio, Texas, United States, 78215
    - Texas Liver Institute/American Research Corporation
  - San Antonio, Texas, United States, 78229
    - Pinnacle Clinical Research - San Antonio
  - San Antonio, Texas, United States, 78209
    - Quality Research - San Antonio
  - San Antonio, Texas, United States, 78215
    - University of California San Diego
  - Sherman, Texas, United States, 75092
    - Sherman Clinical Research
  - Sugar Land, Texas, United States, 77478
    - Olympus Clinical Research
  - Waco, Texas, United States, 76710
    - Impact Research Institute
  - Waco, Texas, United States, 76712
    - Digestive Health Research of Central Texas
  - Webster, Texas, United States, 77598
    - GI Alliance - Bay Area Gastroenterology - Webster
  - Wichita Falls, Texas, United States, 76301
    - Digestive Health Research of North Texas
- Utah
  - Draper, Utah, United States, 84020
    - Lone Peak Family Health
  - Draper, Utah, United States, 84020
    - Physicians' Research Options LLC - Draper UT/Lone Peak Family Clinic
  - Salt Lake City, Utah, United States, 84132
    - University of Utah School of Medicine
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
- Virginia
  - Charlottesville, Virginia, United States, 22903
    - University of Virginia Health System
  - Leesburg, Virginia, United States, 20176
    - Emeritas Research Group
  - Manassas, Virginia, United States, 20110
    - Topography Health, Inc.
  - Newport News, Virginia, United States, 23602
    - Bon Secours Liver Institute of Hampton Roads
  - Norfolk, Virginia, United States, 23502
    - Digestive & Liver Disease Specialists
  - Richmond, Virginia, United States, 23284
    - Virginia Commonwealth University
  - Richmond, Virginia, United States, 23236
    - GI Select Health Research, LLC
  - Richmond, Virginia, United States, 23249
    - Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond
- Washington
  - Seattle, Washington, United States, 98105
    - Liver Institute Northwest
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Froedtert and Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Prescreening Criteria:

Diagnosed with NASH on prior liver biopsy
Type 2 diabetes with high waist circumference or obesity or hepatic steatosis on ultrasound
At least 3 of the components of metabolic syndrome

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):
1. Steatosis score ≥1
2. Activity score: A3 or A4
3. Fibrosis score: F2 or F3
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
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.

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
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
Diabetes mellitus other than type 2
Current treatment with insulin
Treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 12 months before screening or historical biopsy.
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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. Other Names: Lanifibranor 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.
Experimental: 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. Other Names: Lanifibranor
Placebo Comparator: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of NASH and improvement of fibrosis Time Frame: Part A: Date of randomisation until the date of biopsy at Week 72	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 Time Frame: 48 weeks after completion of DBPC period	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inventiva Pharma

Investigators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

337HNAS20011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Corcept Therapeutics

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Al-Azhar University

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Clinical Trials on IVA337

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Proof-of-concept Trial of IVA337 in Diffuse Cutaneous Systemic Sclerosis (FASST)

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Phase 2b Study in NASH to Assess IVA337 (NATIVE)

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Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus (LEGEND)

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United States, Belgium, France, Netherlands, United Kingdom

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

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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