AzTrials
AzTrials

NASH - Nonalcoholic SteatohepatitisPhase 3NATiV3NCT04849728

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 )

A Phase 3 study testing IVA337 in people with NASH - Nonalcoholic Steatohepatitis, run by Inventiva Pharma at 459 sites in 24 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
NASH - Nonalcoholic Steatohepatitis
What is being tested?
IVA337
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,000 participants
Where
459 sitesin 24 countries
Study dates
19 Aug 2021to 30 Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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
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  • 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)

Trial locations and contacts

459 sites in 24 countries.

459 sites in 24 countries

United States194 sites

  • Southwest Gastroenterology Associates

    Albuquerque, New Mexico, 87109

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Digestive Healthcare of Georgia

    Atlanta, Georgia, 30309

  • Accelemed Research Institute

    Austin, Texas, 78745

  • Mercy Medical Center - Mcauley Plaza

    Baltimore, Maryland, 21202

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Objective Health - Birmingham Gastroenterology Associates

    Birmingham, Alabama, 35209

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center - Liver Center

    Boston, Massachusetts, 02215

  • Synergy Healthcare

    Bradenton, Florida, 34208

  • Florida Research Institute

    Bradenton, Florida, 34209

  • South Texas Research Institute - Brownsville

    Brownsville, Texas, 78520

  • State University of New York - University at Buffalo

    Buffalo, New York, 14203

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Fomatmedicalresearch

    Camarillo, California, 93011

  • Digestive Disease Associates - Catonsville

    Catonsville, Maryland, 21228

  • Velocity Clinical Research - Austin

    Cedar Park, Texas, 78613

  • The Institute For Liver Health - Chandler

    Chandler, Arizona, 85224-5688

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Charlotte Gastroenterology and Hepatology - Randolph Road Office

    Charlotte, North Carolina, 28207

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan, 48047

  • Galen Research

    Chesterfield, Missouri, 63005

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60611

  • GW Research

    Chula Vista, California, 91910

  • Velocity Clinical Research, Chula Vista

    Chula Vista, California, 91911

  • Consultants for Clinical Research - Montgomery Office

    Cincinnati, Ohio, 45249

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Gastro Florida

    Clearwater, Florida, 33762

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Heartland Medical Research

    Clive, Iowa, 50325

  • Oracle Clinical Research

    College Park, Georgia, 30349

  • Gastrointestinal (GI) Associates L.L.P.

    Columbia, Missouri, 65201

  • IACT Health

    Columbus, Georgia, 31904

  • The Ohio State University

    Columbus, Ohio, 43201

  • Aventiv Research - Columbus

    Columbus, Ohio, 43213

  • Centricity (Aventiv) Research - Columbus

    Columbus, Ohio, 43213

  • ARcare Center for Clinical Research - Conway

    Conway, Arkansas, 72032

  • Hi Tech and Global Research, LLC

    Coral Gables, Florida, 33134

  • JY Research Institute Inc.

    Cutler Bay, Florida, 33189

  • Top Medical Research

    Cutler Bay, Florida, 33189

  • The Liver Institute at Methodist Dallas

    Dallas, Texas, 75203

  • Liver Center of Texas

    Dallas, Texas, 75234

  • GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown

    Dallas, Texas, 75246

  • Southeast Clinical Research Center

    Dalton, Georgia, 30720

  • Digestive Specialists - Dayton

    Dayton, Ohio, 45414

  • Soma Clinical Trials

    Denison, Texas, 75020

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Digestive Health Specialist of the Southeast

    Dothan, Alabama, 36305

  • Lone Peak Family Health

    Draper, Utah, 84020

  • Physicians' Research Options LLC - Draper UT/Lone Peak Family Clinic

    Draper, Utah, 84020

  • Ohio Gastroenterology Group, Inc. - Olentangy Office

    Dublin, Ohio, 43016

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Icahn School of Medicine at Mount Sinai

    Durham, North Carolina, 27710

  • South Texas Research Institute - Edinburg

    Edinburg, Texas, 78539

  • TriWest Research Associates

    El Cajon, California, 92020

  • South Denver Gastroenterology - Swedish Medical Center Office

    Englewood, Colorado, 80113

  • NECCR Prima Care Research, LLC

    Fall River, Massachusetts, 02721

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • Gastrointestinal Associates & Endoscopy Center - Flowood

    Flowood, Mississippi, 39232

  • Care United Medical Center - Forney

    Forney, Texas, 75126

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Cure Clinical Research, LLC

    Fountain Valley, California, 92708

  • SC Clinical Research

    Garden Grove, California, 92844

  • Velocity Clinical Research - Gardena

    Gardena, California, 90247

  • Digestive Health Associates of Texas - Rockwall

    Garland, Texas, 75044

  • Gastro One - Germantown Office - Wolf Park Drive

    Germantown, Tennessee, 38138

  • Mid-Atlantic GI Research

    Greenbelt, Maryland, 20770

  • Carolina Digestive Diseases

    Greenville, North Carolina, 27834

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • ASHA Clinical Research - Munster

    Hammond, Indiana, 46324

  • Doral Medical Research, LLC

    Hialeah, Florida, 33016

  • Palmetto Research

    Hialeah, Florida, 33016

  • Tandem Clinical Research GI

    Houma, Louisiana, 70363

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Liver Associates of Texas

    Houston, Texas, 77030

  • Liver Specialists of Texas

    Houston, Texas, 77030

  • Houston Research Institute (HRI)

    Houston, Texas, 77079

  • Pioneer Research Solutions

    Houston, Texas, 77099

  • National Research Institute - Santa Ana

    Huntington Park, California, 92704

  • Grand Teton Research Group, PLLC

    Idaho Falls, Idaho, 83404

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Arizona Digestive Health - Sun City

    Kansas City, Kansas, 66160

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Combined Gastro Research LLC

    Lafayette, Louisiana, 70503

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • The Clinical Trials Network - Gastro Care Institute

    Lancaster, California, 93534

  • Sierra Clinical Research - Las Vegas

    Las Vegas, Nevada, 89106

  • Emeritas Research Group

    Leesburg, Virginia, 20176

  • Galenus Group

    Lehigh Acres, Florida, 33936

  • University of Kentucky

    Lexington, Kentucky, 40506-0032

  • ARcare Center for Clinical Research

    Little Rock, Arkansas, 72205

  • Arkansas Diagnostic Center

    Little Rock, Arkansas, 72205

  • Summit - Pinnacle Clinical Research - Austin

    Live Oak, Texas, 78233

  • National Research Institute - Westlake

    Los Angeles, California, 90057

  • GI Alliance - Lubbock Digestive Disease Associates - Lubbock

    Lubbock, Texas, 79410

  • North Alabama GI Research Center llc

    Madison, Alabama, 60602

  • Accel Research Sites

    Maitland, Florida, 32751

  • Centor for Advanced Gastroenterology - Main Office - Maitland

    Maitland, Florida, 32751

  • Topography Health, Inc.

    Manassas, Virginia, 20110

  • GI Alliance - Mansfield

    Mansfield, Texas, 76063

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • Koncord Research - McAllen LLC

    McAllen, Texas, 78504

  • Koncord Research-McAllen LLC

    McAllen, Texas, 78504

  • Great Lakes Gastroenterology Research - Mentor

    Mentor, Ohio, 44060

  • Metropolitan Gastroenterology Associates - Metairie

    Metairie, Louisiana, 70006

  • Florida Vascular Research

    Miami, Florida, 33012

  • Life Medical Research Group

    Miami, Florida, 33122

  • Schiff Center for Liver Diseases

    Miami, Florida, 33136

  • D&H National Research Centers

    Miami, Florida, 33155

  • Future Care Solution

    Miami, Florida, 33165

  • Genoma Research Group

    Miami, Florida, 33165

  • Gastro Health - Galloway

    Miami, Florida, 33173

  • Pro Live Medical Research

    Miami, Florida, 33175

  • Miami Dade Medical Research Institute

    Miami, Florida, 33176

  • Clinical Trials Services Corporation

    Miami, Florida, 33181

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • MNGI Digestive Health - Northeast Minneapolis Clinic

    Minneapolis, Minnesota, 55413

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale School of Medicine

    New Haven, Connecticut, 06520

  • Advanced Research Institute

    New Port Richey, Florida, 34653

  • New York University Langone Gastroenterology Associates

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Tandem Clinical Research - New York Clinic

    New York, New York, 10033

  • Bon Secours Liver Institute of Hampton Roads

    Newport News, Virginia, 23602

  • Digestive & Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Summit - Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Sensible Healthcare Clinical Research

    Ocoee, Florida, 34761

  • AdventHealth Transplant Institute

    Orlando, Florida, 32804

  • Digestive and Liver Center of Florida - Orlando

    Orlando, Florida, 32825

  • IMIC Research - International Medical Investigations Centers

    Palmetto Bay, Florida, 33157

  • National Research Institute - Panorama City

    Panorama City, California, 91402

  • California Liver Reearch

    Pasadena, California, 91105

  • American Research Centers of Florida

    Pembroke Pines, Florida, 33027

  • Pensacola GI Research Center

    Pensacola, Florida, 32503

  • Arizona Liver Health - Peoria

    Peoria, Arizona, 85381

  • Dignity Health - St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Veterans Affairs Pittsburgh Healthcare System - University Drive Campus

    Pittsburgh, Pennsylvania, 15240

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15261

  • Eminat, LLC

    Plantation, Florida, 33317

  • D & H Pompano Research Center

    Pompano Beach, Florida, 33064

  • NAPA Research

    Pompano Beach, Florida, 33064

  • Cadena Care Institute

    Poway, California, 92064

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • Stanford University Medical Center

    Redwood City, California, 94063

  • GI Select Health Research, LLC

    Richmond, Virginia, 23236

  • Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23284

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • University of Utah School of Medicine

    Salt Lake City, Utah, 84132

  • Quality Research - San Antonio

    San Antonio, Texas, 78209

  • Sun Research Institute

    San Antonio, Texas, 78215

  • Texas Liver Institute/American Research Corporation

    San Antonio, Texas, 78215

  • University of California San Diego

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Research and Education, Inc.

    San Diego, California, 92111

  • California Pacific Medical Center Research Institute

    San Francisco, California, 64107

  • Quest Clinical Research

    San Francisco, California, 94115

  • Silicon Valley Research Institute

    San Jose, California, 95128

  • Covenant Metabolic Specialists LLC - Sarasota

    Sarasota, Florida, 34420

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Sherman Clinical Research

    Sherman, Texas, 75092

  • Louisiana Research Center LLC

    Shreveport, Louisiana, 71103

  • NorthShore University HealthSystem

    Skokie, Illinois, 60077

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110

  • Richmond University Medical Center

    Staten Island, New York, 10310

  • Olympus Clinical Research

    Sugar Land, Texas, 77478

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Clinical Trial Management Services

    Thousand Oaks, California, 91360

  • Kansas Medical Clinic - Gastroenterology

    Topeka, Kansas, 66606

  • Adobe Gastroenterology

    Tucson, Arizona, 85712

  • Arizona Liver Health

    Tucson, Arizona, 85712

  • Options Health Research

    Tulsa, Oklahoma, 74104

  • San Fernando Valley Health Institute

    Van Nuys, California, 91405

  • Impact Research Institute

    Waco, Texas, 76710

  • Digestive Health Research of Central Texas

    Waco, Texas, 76712

  • GI Alliance - Bay Area Gastroenterology - Webster

    Webster, Texas, 77598

  • Clinovacare Medical Clinical Research Center

    West Columbia, South Carolina, 29169

  • North Shore Gastroenterology

    Westlake, Ohio, 44145

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • Digestive Health Research of North Texas

    Wichita Falls, Texas, 76301

  • Gastroenterology of the Piedmont, PA - Salem Office

    Winston-Salem, North Carolina, 27103

  • Gastroenterology Associates of Western Michigan

    Wyoming, Michigan, 49519

  • Florida Medical Clinic - Zephyrhills

    Zephyrhills, Florida, 33542

Other trials in United States

China71 sites

  • Beijing Ditan Hospital Capital Medical University

    Beijing, Beijing Municipality, 100010

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • Peking University People's Hospital

    Beijing, Beijing Municipality

  • Beijing You'an Hospital,Capital Medical University

    Beijing, Fengtai

  • The First Hospital of Jilin University

    Changchun

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410699

  • Xiangya Hospital - Central South University

    Changsha

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan Shi

  • West china hospital Sichuan University

    Chengdu

  • Chongqing university three gorges hospital

    Chongqing, Chongging

  • First Affiliated Hospital of the Army Military Medical University (Southwest Hospital)

    Chongqing, Chongging

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Mengchao Hepatobiliary Hospital of FuJian Medical University

    Fuzhou

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong

  • The Eighth Affiliated Hospital,GuangZhou Medical University

    Guangzhou, Guangdong

  • The First Affiliated Hospital Sun Yat-sen University

    Guangzhou, Guangdong

  • Guangdong Provincial people's hospital

    Guangzhou

  • The Third Affiliated Hospital, Sun Yat-Sen University

    Guangzhou

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The First Affiliated Hospital , Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Qingchun Campus

    Hangzhou

  • Heilongjiang Provincial Hospital

    Harbin, Heilongjiang, 150036

  • Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • General Hospital of Tianjin Medical University

    Heping

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • Ningbo No.2 Hospital (Hwa Mei Hospital)

    Ningbo

  • Qingdao Central Hospital

    Qingdao, Shandong

  • Qingdao Municipal Hospital

    Qingdao

  • RuiAn People's Hospital - Ruixiang Branch

    Ruian, Zhejiang

  • Sanmenxia Central Hospital

    Sanmenxia, Henan

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

  • The Sixth People' s Hospital Of ShenYang

    Shenyang, Liaoning

  • Shengjing Hospital of China Medical University

    Shenyang

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050052

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu

  • Xu, Jun The First Hospital of Shanxi Medical University Taiyun Shanxi

    Taiyuan, Shanxi

  • Tianjin Third Central Hospital

    Tianjin

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • Wuxi No.5 People's Hospital

    Wuxi, Jiangsu

  • Xi'an International Medical Center

    Xi'an, Shaanxi, 710126

  • Xi'an International Medical Center

    Xi'an, Shaanxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • The Third Affiliated Hospital Of Xinxiang Medical University

    Xinxiang, Henan, 453000

  • Yiwu Central Hospital

    Yiwu, Zhejiang, 322000

  • Yue Yang Central Hospital

    Yueyang, Hunan, 414000

  • Henan Provincal People's Hospital

    Zhengzhou, Henan

  • The Sixth People's Hospital of Zhengzhou

    Zhengzhou, Henan

  • Zhengzhou First People's Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

  • Zhengzhou People's Hospital

    Zhengzhou

  • Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu

Other trials in China

France27 sites

  • Centre Hosptitalier Universitaire d'Angers

    Angers, Maine-et-Loire, 49933

  • Centre Hosptitalier Universitaire d'Angers

    Angers, Maine-et-Loire

  • CHRU de Besançon - Hôpital Jean-Minjoz

    Besançon, Franche-Comté, 25030

  • Centre Hospitalier Universitaire Estaing

    Clermont-Ferrand, Puy-de-Dôme, 63003

  • Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon

    Clichy, Île-de-France Region, 92118

  • Hôpitaux Universitaires Henri Mondor

    Créteil, Île-de-France Region, 94000

  • CHU Dijon Bourgogne - Hôpital François Mitterrand

    Dijon, Cantal

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, Isère, 38043

  • CHU de Lille - Hôpital Claude Huriez

    Lille, Hauts-de-France, 59037

  • CHU de Limoges

    Limoges, Limousin, 87042

  • Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes, 69317

  • Hôpital Saint-Joseph

    Marseille, Bouches-du-Rhône, 13008

  • CHU Saint-Eloi

    Montpellier, Occitanie, 34295

  • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

    Nantes, Loire Atlantique, 44903

  • Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec

    Nantes, Nantes Cedex 1

  • Hôpital l'Archet

    Nice, Provence-Alpes-Côte d'Azur Region, 06200

  • Hôpital Universitaire Pitié Salpêtrière

    Paris, Île-de-France Region, 75013

  • Hôpital Saint-Antoine

    Paris, Île-de-France Region, 75571

  • Hôpital Haut-Lévêque

    Pessac, New Aquitaine, 33604

  • Hôpital Haut-Lévêque

    Pessac, New Aquitaine

  • Centre Hospitalier Universitaire de Rennes

    Rennes, Ille-et-Vilaine, 35033

  • Hôpital Hautepierre

    Strasbourg, Bas-Rhin, 67200

  • Hôpital Rangueil

    Toulouse, Occitanie, 31059

  • Clinique Pasteur

    Toulouse, Occitanie, 31076

  • Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Lorraine, 54511

  • Hôpitaux de Brabois

    Vandœuvre-lès-Nancy, Lorraine

  • Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse

    Villejuif, Île-de-France Region, 94804

Other trials in France

Spain19 sites

  • Complejo Hospitalario Torrecárdenas

    Almería, Almería, 04009

  • Hospital Germans Trias i Pujol

    Badalona, Badalona, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona, 08035

  • Hospital Universitari Vall d'Hebrón

    Barcelona, Barcelona, 08035

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

  • Complejo Asistencial Universitario de Leon

    León, León, 24080

  • Hospital General Universitario Gregorio Marañón

    Madrid, Madrid, 28007

  • Clínica Universidad de Navarra

    Madrid, Madrid, 28027

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Complejo Hospitalario De Pontevedra

    Pontevedra, Pontevedra, 36004

  • Consorci Corporació Sanitària Parc Taulí de Sabadell

    Sabadell, Barcelona, 08208

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla, 41011

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Consorci Hospital General Universitari de València

    Valencia, Valencia, 46014

  • Hospital Universitario Rio Hortega

    Valladolid, Valladolid, 47012

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, Zaragoza, 50009

Other trials in Spain

Mexico18 sites

  • Centro de Investigación y Gastroenterología

    Cuauhtémoc, Mexico City, 06700

  • PanAmerican Clinical Research Mexico - Cuernavaca

    Cuernavaca, Morelos

  • Centro de Investigacion Medico Biologica y Terapia Avanzada

    Guadalajara, Jalisco

  • Medical Care and Research S.A. de C.V.

    Mérida, Yucatán, 97070

  • Consultorio de la Dra. Maria Sarai Gonzalez Huezo

    Metepec

  • Instituto de Seguridad Social del Estado de Mexico y Municipios

    Metepec

  • Oaxaca Site Management Organization S.C.

    Metepec

  • Centro de Investigacion y Gastroenterologia, S.C.

    Mexico City, Mexico City, 03330

  • Organismo Publico Descentralizado Hospital Juarez de Mexico

    Mexico City, Mexico City, 7760

  • Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)

    Mexico City

  • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

    Mexico City

  • Investigaciones Medicas Cisneros

    Monterrey, Nuevo León, 64000

  • Hospital Universitario Doctor José Eleuterio Gonzalez

    Monterrey, Nuevo León, 64460

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" (Servicio de Gastroenterologia)

    Monterrey

  • Hospital Universitario "Dr. José Eleuterio González" (Servicio de Endocrinología)

    Monterrey

  • Hospital Universitario Dr. José Eleuterio González

    Monterrey

  • Oaxaca Site Management Organization S.C.

    Oaxaca City

  • Hospital Regional de Alta Especialidad de Zumpango

    Zumpango

Other trials in Mexico

Germany12 sites

  • EPIMED

    Berlin, State of Berlin, 10787

  • Gastroenterologie am Bayerischen Platz

    Berlin, State of Berlin, 10825

  • Charité Universitätsmedizin Berlin

    Berlin, State of Berlin, 13353

  • Klinikum Chemnitz

    Chemnitz, Saxony, 09116

  • Uniklinik Köln

    Cologne

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum des Saarlandes

    Homburg, Saarland, 66421

  • Eugastro

    Leipzig, Saxony, 04103

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, Schleswig-Holstein

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Universitätsklinikum Düsseldorf

    Northeim

  • St. Josefs-Hospital Wiesbaden

    Wiesbaden, Hesse, 65189

Other trials in Germany

United Kingdom12 sites

  • Panthera Biopartners - Glasgow

    Glasgow, North Lanarkshire, G51 4TF

  • Barts Health NHS Trust

    London, England, E1 1BB

  • Panthera Biopartners - North London

    London, England, EN1 1LJ

  • King's College Hospital NHS Foundation Trust

    London, England, SE5 9RS

  • Royal Free London NHS Foundation Trust

    London

  • Panthera Biopartners - Manchester

    Manchester, England, OL11 4AU

  • Panthera Biopartners - Manchester

    Manchester, England

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, England, NE7 7DN

  • Nottingham University Hospitals NHS Trust

    Nottingham, England

  • Panthera Biopartners - Preston

    Preston, England, PR2 9QB

  • Sheffield Teaching Hospitals NHS FT

    Sheffield, England

  • Royal Surrey County Hospital NHS Foundation Trust

    Surrey Quays, England, GU2 7XX

Other trials in United Kingdom

Australia11 sites

  • Eastern Health - Australia

    Box Hill, Victoria, 3128

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • Gallipoli Medical Research Foundation

    Greenslopes, Queensland, 4120

  • Austin Health

    Heidelberg, Victoria, 3084

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Campbelltown Hospital

    Liverpool, New South Wales, 2170

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

  • Nepean Hospital

    Penrith, New South Wales, 2750

  • Royal Perth Hospital

    Perth, Western Australia, 6000

Other trials in Australia

Poland11 sites

  • Synexus - Częstochowa

    Częstochowa, Silesian Voivodeship, 42-202

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80-382

  • Synexus - Gdynia

    Gdynia, Pomeranian Voivodeship, 81-537

  • Synexus - Katowice

    Katowice, Silesian Voivodeship, 40-040

  • Centrum Medyczne Pratia - Katowice

    Katowice, Silesian Voivodeship, 40-081

  • Synexus - Łódź

    Lodz, Łódź Voivodeship, 90-127

  • ID Clinic

    Mysłowice, Silesian Voivodeship, 41-400

  • Synexus - Poznań

    Poznan, Greater Poland Voivodeship, 60-702

  • Synexus - Warszawa

    Warsaw, Masovian Voivodeship, 01-192

  • Synexus - Wrocław

    Wroclaw, Lower Silesian Voivodeship, 50-381

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych

    Wroclaw, Lower Silesian Voivodeship, 51-162

Other trials in Poland

Belgium10 sites

  • Hôpital Erasme

    Brussels, Brussels Capital, 1070

  • Cliniques Universitaires Saint-Luc

    Brussels, Brussels Capital, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerpen, 2650

  • Ziekenhuis Oost-Limburg - Campus Sint-Jan

    Genk, Limburg, 3600

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaaderen, 9000

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen, 9000

  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, Flemish Brabant, 3000

  • Centre Hospitalier Universitaire de Liège Site Sart Tilman

    Liège, Liège, B-4000

  • Algemeen Ziekenhuis Delta - Campus Rumbeke

    Roeselare, West-Vlaanderen, 8800

  • Vitaz

    Sint-Niklaas, Oost-Vlaanderen, 9100

Other trials in Belgium

Italy10 sites

  • Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi

    Bologna

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Milan, 20122

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Milan, 20162

  • Università degli Studi di Napoli Federico II

    Naples, Napoli

  • Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

    Novara, 28100

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

    Palermo, Palermo

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Roma

  • UOSD Interdipartimentale Degenza Medica a ciclo breve

    Roma

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Israel9 sites

  • Soroka Medical Center

    Beersheba, Southern District, 84101

  • Rambam Health Care Campus

    Haifa, Haifa District, 3109601

  • Carmel Medical Center

    Haifa, Haifa District, 3436212

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9103102

  • Hadassah University Hospital Ein Kerem

    Jerusalem, Jerusalem, 9112001

  • Western Galilee Hospital-Nahariya

    Nahariya, Northern District, 22100

  • The Chaim Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Gush Dan, 64239

  • The Chaim Sheba Medical Center

    Tel Aviv, Tel Aviv, 69710

Other trials in Israel

Canada7 sites

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • Heritage Medical Research Centre

    Calgary, Alberta, T2N 4Z6

  • St. Joseph's Healthcare Hamilton - Charlton Campus

    Hamilton, Ontario, L8N 4A6

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Centre de Médecine Métabolique de Lanaudière

    Terrebonne, Quebec, J6X 497

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Toronto Digestive Disease Associates

    Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Argentina6 sites

  • Hospital De Alta Complejidad en Red El Cruce

    Buenos Aires, Buenos Aires, C1124AAD

  • Hospital Británico de Buenos Aires

    Buenos Aires, Buenos Aires, C1280AEB

  • Hospital Italiano de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB

  • Hospital Italiano La Plata

    La Plata, Buenos Aires, B1900AXI

  • Hospital Universitario Austral

    Pilar, Buenos Aires, B1629AHJ

  • Hospital Provincial del Centenario

    Rosario, Santa Fe Province, S2002KDS

Other trials in Argentina

Bulgaria6 sites

  • Acibadem City Clinic Tokuda Hospital

    Sofia, Sofia, 1407

  • Diagnostic Consultative Center Aleksandrovska

    Sofia, Sofia, 1431

  • Diagnostic Consulting Center 20 - Sofia Еооd

    Sofia, Sofia, 1618

  • University Multiprofile Hospital for Active Treatment St. Ivan Rilski

    Sofia, Sofia-Grad, 1431

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov

    Sofia, Sofia-Grad, 1612

  • Medical Center Medica Plus

    Veliko Tarnovo, Veliko Tarnovo, 5006

Other trials in Bulgaria

Netherlands6 sites

  • Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum

    Amsterdam, North Holland, 1081 HV

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 GD

  • Franciscus Gasthuis & Vlietland

    Rotterdam

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, North Brabant, 5000 LC

  • Ziekenhuis Bernhoven

    Uden, North Brabent, 5400

  • Universitair Medisch Centrum Utrecht

    Utrecht, Utrecht, 3584 CX

Other trials in Netherlands

Portugal6 sites

  • Hospital de Braga

    Braga, Braga District, 4710-243

  • Hospital da Senhora da Oliveira - Guimarães

    Guimarães, Braga District, 4835-044

  • Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria

    Lisbon, Lisbon District, 1649-035

  • Centro Hospitalar Universitário De São João

    Porto, Porto District, 4200-319

  • Hospital Pedro Hispano

    Senhora da Hora, Senhora Da Hora, Senhora Da Hora

  • Centro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. Pedro

    Vila Real, Vila Real District

Other trials in Portugal

South Africa6 sites

  • CTN (Clinical Trials Network): Somerset

    Cape Town, Western Cape, 7130

  • Synexus - Mediclinic Southern Africa - Constantiaberg

    Cape Town, Western Cape, 7800

  • Clinresco Centres

    Kempton Park, Gauteng, 1619

  • Synexus Clinical Research SA- Watermeyer

    Pretoria, Gauteng, 184

  • Synexus Clinical Research SA- Watermeyer

    Pretoria, Pretoria, 0184

  • Synexus - Helderberg Clinical Research Centre - Somerset West

    Somerset West, Western Cape, 7130

Other trials in South Africa

Brazil5 sites

  • Hospital das Clinicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    Cerqueira César, São Paulo, 05403-000

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

Other trials in Brazil

Hungary5 sites

  • MIND Klinika

    Budapest, Budapest, 1024

  • SYNEXUS Magyarország Egészségügyi Szolgáltató KFT

    Budapest, Central Hungary, 1036

  • High Tech Medical Kft.

    Budapest, 1064

  • Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen

    Debrecen, Hajdú-Bihar, 4025

  • Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus

    Debrecen, Hajdú-Bihar, 4031

Other trials in Hungary

Chile3 sites

  • Hospital San Juan de Dios de La Serena

    La Serena, Coquimbo Region, 1700000

  • Pontificia Universidad Católica de Chile - Escuela de Medicina

    Santiago, Santiago Metropolitan, 8320000

  • Centro De Investigaciones Clínicas Viña Del Mar

    Viña del Mar, Valparaiso, 2540364

Other trials in Chile

Puerto Rico2 sites

  • Galenus Group of Pureto Rico

    Manati, Pureto Rico, 00674

  • Fundación de Investigación de Diego Clinical Research

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

Ukraine2 sites

  • Medical Center Medbud-Clinic, LLC

    Kyiv, Kyiv Oblast, 3037

  • Medical Center Center of Family Medicine Plus, LLC

    Kyiv, Kyiv Oblast, 4210

Other trials in Ukraine

Czechia1 site

  • Synexus Czech - DRS Prague

    Prague, 120 00

Other trials in Czechia

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis Stages F2 and F3

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

Read the 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)
Being tested
IVA337, Placebo
Keywords
Phase III, Nonalcoholic Steatohepatitis, NASH, Peroxisome proliferator-activated receptor (PPAR), Liver Diseases, Fibrosis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Liver Diseases, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IVA337Drug

    Also called Lanifibranor

    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.

  • PlaceboDrug

    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.

Study groups in NCT04849728
Study groupRoleWhat they receive
Lanifibranor (IVA 337) (800 mg/day)Experimental2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)
Receives: Drug: IVA337; Drug: Placebo
Lanifibranor (IVA 337) (1200 mg/day)Experimental3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)
Receives: Drug: IVA337
Matching placeboPlacebo comparator3 Placebo to match tablets with food --> once a day (quaque die, QD)
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resolution of NASH and improvement of fibrosis

    Part A: DBPC: Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline

    Measured: Part A: Date of randomisation until the date of biopsy at Week 72

  2. Safety Analyses

    Part B: ATE:

    • Using the DBPC on-treatment period, comparing the 2 active arms versus placebo
    • Using the DBPC +ATE on treatment periods, assessing the 2 active arms. For adverse events, adjudicated liver events, and DILI and MACE events, in addition to the raw cumulative incidence proportions, the exposure-adjusted incidence rates will be provided based on the time patients are at risk.

    Measured: 48 weeks after completion of DBPC period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start19 Aug 2021
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04849728
Sponsor's protocol ID
337HNAS20011
Acronym
NATiV3
Status last verified
Mar 2026
First submitted
16 Apr 2021
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IVA337 in people with NASH - Nonalcoholic Steatohepatitis, run by Inventiva Pharma at 459 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 459 sites in United States, China, France, Spain, Mexico and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resolution of NASH and improvement of fibrosis (time frame: Part A: Date of randomisation until the date of biopsy at Week 72). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04849728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.

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