RECRUITING

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 )

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Conditions

NASH - Nonalcoholic SteatohepatitisPhase IIINonalcoholic SteatohepatitisNASHPeroxisome proliferator-activated receptor (PPAR)Liver DiseasesFibrosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2021-08-19
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04849728

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.

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

Contacts and Locations

Study Contact

Pascaline Clerc
CONTACT
2024998937/0644637545
clinical.contact@inventivapharma.com

Principal Investigator

Arun J Sanyal, MD
PRINCIPAL_INVESTIGATOR
VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
Sven Francque, MD
PRINCIPAL_INVESTIGATOR
Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium

Study Locations (Sites)

Pinnacle Research Group
Anniston, Alabama, 36207
United States
Objective Health - Birmingham Gastroenterology Associates
Birmingham, Alabama, 35209
United States
Digestive Health Specialist of the Southeast
Dothan, Alabama, 36305
United States
North Alabama GI Research Center llc
Madison, Alabama, 60602
United States
The Institute For Liver Health - Chandler
Chandler, Arizona, 85224-5688
United States
Arizona Liver Health - Peoria
Peoria, Arizona, 85381
United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
United States
Arizona Digestive Health - Sun City
Tucson, Arizona, 85351
United States
Adobe Gastroenterology
Tucson, Arizona, 85712
United States
Arizona Liver Health
Tucson, Arizona, 85712
United States
Del Sol Research Management - Tucson East
Tucson, Arizona, 85715
United States
ARcare Center for Clinical Research - Conway
Conway, Arkansas, 72032
United States
ARcare Center for Clinical Research
Little Rock, Arkansas, 72205
United States
Arkansas Diagnostic Center
Little Rock, Arkansas, 72205
United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
United States
Office of Franco Felizarta, MD
Bakersfield, California, 93301
United States
Fomatmedicalresearch
Camarillo, California, 93011
United States
Precision Research Institute
Chula Vista, California, 91909
United States
GW Research
Chula Vista, California, 91910
United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, 91911
United States
TriWest Research Associates
El Cajon, California, 92020
United States
Cure Clinical Research, LLC
Fountain Valley, California, 92708
United States
SC Clinical Research
Garden Grove, California, 92844
United States
National Research Institute - Santa Ana
Huntington Park, California, 92704
United States
The Clinical Trials Network - Gastro Care Institute
Lancaster, California, 93534
United States
National Research Institute - Westlake
Los Angeles, California, 90057
United States
National Research Institute - Panorama City
Panorama City, California, 91402
United States
California Liver Reearch
Pasadena, California, 91105
United States
Cadena Care Institute
Poway, California, 92064
United States
Prospective Research Innovations Inc.
Rancho Cucamonga, California, 91730
United States
Stanford University Medical Center
Redwood City, California, 94063
United States
Inland Empire Liver Foundation
Rialto, California, 92377
United States
Research and Education, Inc.
San Diego, California, 92111
United States
California Pacific Medical Center Research Institute
San Francisco, California, 64107
United States
Quest Clinical Research
San Francisco, California, 94115
United States
Silicon Valley Research Institute
San Jose, California, 95128
United States
Clinical Trial Management Services
Thousand Oaks, California, 91360
United States
San Fernando Valley Health Institute
Van Nuys, California, 91405
United States
South Denver Gastroenterology - Swedish Medical Center Office
Englewood, Colorado, 80113
United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610
United States
Yale School of Medicine
New Haven, Connecticut, 06520
United States
MedBio Trials
Adventura, Florida, 33180
United States
Excel Medical Clinical Trials, LLC
Boca Raton, Florida, 33434
United States
Synergy Healthcare
Bradenton, Florida, 34208
United States
Tampa Bay Medical Research
Clearwater, Florida, 33761
United States
Gastro Florida
Clearwater, Florida, 33762
United States
Hi Tech and Global Research, LLC
Coral Gables, Florida, 33134
United States
American Research Institute, INC
Cutler Bay, Florida, 33157
United States
JY Research Institute Inc.
Cutler Bay, Florida, 33189
United States
Top Medical Research
Cutler Bay, Florida, 33189
United States
Doral Medical Research, LLC
Hialeah, Florida, 33016
United States
Palmetto Research
Hialeah, Florida, 33016
United States
Florida Research Institute
Lakewood Ranch, Florida, 34211
United States
Galenus Group
Lehigh Acres, Florida, 33936
United States
Accel Research Sites
Maitland, Florida, 32751
United States
Centor for Advanced Gastroenterology - Main Office - Maitland
Maitland, Florida, 32751
United States
Florida Vascular Research
Miami, Florida, 33012
United States
Life Medical Research Group
Miami, Florida, 33122
United States
Optimus U Corporation
Miami, Florida, 33125
United States
Schiff Center for Liver Diseases
Miami, Florida, 33136
United States
D&H National Research Centers
Miami, Florida, 33155
United States
USPA Advance Concept Medical Research Group
Miami, Florida, 33157
United States
Future Care Solution
Miami, Florida, 33165
United States
Genoma Research Group
Miami, Florida, 33165
United States
Gastro Health - Galloway
Miami, Florida, 33173
United States
Pro Live Medical Research
Miami, Florida, 33175
United States
Miami Dade Medical Research Institute
Miami, Florida, 33176
United States
Clinical Trials Services Corporation
Miami, Florida, 33181
United States
Advanced Research Institute
New Port Richey, Florida, 34653
United States
Sensible Healthcare Clinical Research
Ocoee, Florida, 34761
United States
AdventHealth Transplant Institute
Orlando, Florida, 32804
United States
Digestive and Liver Center of Florida - Orlando
Orlando, Florida, 32825
United States
IMIC Research - International Medical Investigations Centers
Palmetto Bay, Florida, 33157
United States
American Research Centers of Florida
Pembroke Pines, Florida, 33027
United States
Pensacola GI Research Center
Pensacola, Florida, 32503
United States
Eminat, LLC
Plantation, Florida, 33317
United States
NAPA Research
Pompano Beach, Florida, 33064
United States
Covenant Metabolic Specialists LLC - Sarasota
Sarasota, Florida, 34420
United States
Tampa General Hospital
Tampa, Florida, 33606
United States
GI Alliance - Gastroenterology Associates of Florida - Wellington
Wellington, Florida, 33414
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Florida Medical Clinic - Zephyrhills
Zephyrhills, Florida, 33542
United States
Athens Gastroenterology Association
Athens, Georgia, 30607
United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
United States
Research and Education Foundation of Atlanta Medical Center
Atlanta, Georgia, 30312
United States
Oracle Clinical Research
College Park, Georgia, 30349
United States
IACT Health
Columbus, Georgia, 31904
United States
Southeast Clinical Research Center
Dalton, Georgia, 30720
United States
Regional Infectious Diseases and Infusion Center
LaGrange, Georgia, 30240
United States
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago
Chicago, Illinois, 60611
United States
NorthShore University HealthSystem
Skokie, Illinois, 60077
United States
ASHA Clinical Research - Munster
Hammond, Indiana, 46324
United States
Heartland Medical Research
Clive, Iowa, 50325
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Arizona Digestive Health - Sun City
Kansas City, Kansas, 66160
United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
United States
Kansas Medical Clinic - Gastroenterology
Topeka, Kansas, 66606
United States
University of Kentucky
Lexington, Kentucky, 40506-0032
United States
Gastroenterology Associates - Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Tandem Clinical Research GI
Houma, Louisiana, 70363
United States
Combined Gastro Research LLC
Lafayette, Louisiana, 70503
United States
Tandem Clinical Research
Marrero, Louisiana, 70072
United States
Metropolitan Gastroenterology Associates - Metairie
Metairie, Louisiana, 70006
United States
Tandem Clinical Research GI, LLC
Metairie, Louisiana, 70006
United States
Louisiana Research Center LLC
Shreveport, Louisiana, 71103
United States
Investigative Clinical Research - Annapolis
Annapolis, Maryland, 21401
United States
Mercy Medical Center - Mcauley Plaza
Baltimore, Maryland, 21202
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Digestive Disease Associates - Catonsville
Catonsville, Maryland, 21228
United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
United States
Gastro Center of Maryland - Columbia
Columbia, Maryland, 21045
United States
Mid-Atlantic GI Research
Greenbelt, Maryland, 20770
United States
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Beth Israel Deaconess Medical Center - Liver Center
Boston, Massachusetts, 02215
United States
NECCR Prima Care Research, LLC
Fall River, Massachusetts, 02721
United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519
United States
University of Michigan Health-West Hospital
Wyoming, Michigan, 49519
United States
MNGI Digestive Health - Northeast Minneapolis Clinic
Minneapolis, Minnesota, 55413
United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
United States
Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood, Mississippi, 39232
United States
SKYCRNG - Quinn Healthcare
Ridgeland, Mississippi, 39157
United States
Galen Research
Chesterfield, Missouri, 63005
United States
Gastrointestinal (GI) Associates L.L.P.
Columbia, Missouri, 65201
United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
United States
Kansas City Research Institute
Kansas City, Missouri, 64131
United States
SSM Health Saint Louis University Hospital
Saint Louis, Missouri, 63104
United States
Washington University School of Medicine in St. Louis
Saint Louis, Missouri, 63110
United States
Sierra Clinical Research - Las Vegas
Las Vegas, Nevada, 89106
United States
Southwest Gastroenterology Associates
Albuquerque, New Mexico, 87109
United States
State University of New York - University at Buffalo
Buffalo, New York, 14203
United States
Weill Cornell Medical College
New York, New York, 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Tandem Clinical Research - New York Clinic
New York, New York, 10033
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
Richmond University Medical Center
Staten Island, New York, 10310
United States
Charlotte Gastroenterology and Hepatology - Randolph Road Office
Charlotte, North Carolina, 28207
United States
ObjectiveGI - Northeast GI Research
Concord, North Carolina, 28027
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Cumberland Research Associates
Fayetteville, North Carolina, 28304
United States
Carolina Digestive Diseases
Greenville, North Carolina, 27834
United States
Lucas Research, Inc
Morehead City, North Carolina, 28557
United States
Gastroenterology of the Piedmont, PA - Salem Office
Winston-Salem, North Carolina, 27103
United States
Consultants for Clinical Research - Montgomery Office
Cincinnati, Ohio, 45249
United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
United States
The Ohio State University
Columbus, Ohio, 43201
United States
Aventiv Research - Columbus
Columbus, Ohio, 43213
United States
Digestive Specialists - Dayton
Dayton, Ohio, 45414
United States
Ohio Gastroenterology Group, Inc. - Olentangy Office
Dublin, Ohio, 43016
United States
Great Lakes Gastroenterology Research - Mentor
Mentor, Ohio, 44060
United States
North Shore Gastroenterology
Westlake, Ohio, 44145
United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
United States
Options Health Research
Tulsa, Oklahoma, 74104
United States
Veterans Affairs Pittsburgh Healthcare System - University Drive Campus
Pittsburgh, Pennsylvania, 15240
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Palmetto Clinical Research
Summerville, South Carolina, 29485
United States
Clinovacare Medical Clinical Research Center
West Columbia, South Carolina, 29169
United States
Rapid City Medical Center
Rapid City, South Dakota, 57701
United States
Gastro One - Germantown Office - Wolf Park Drive
Germantown, Tennessee, 38138
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Clinical Research Institute
Arlington, Texas, 76012
United States
Accelemed Research Institute
Austin, Texas, 78745
United States
Pinnacle Clinical Research - Austin
Austin, Texas, 78757
United States
Gadolin Research
Beaumont, Texas, 77702
United States
South Texas Research Institute - Brownsville
Brownsville, Texas, 78520
United States
PanAmerican Clinical Research - US Headquarters
Brownsville, Texas, 78521
United States
Velocity Clinical Research - Austin
Cedar Park, Texas, 78613
United States
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
United States
Liver Center of Texas
Dallas, Texas, 75234
United States
GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown
Dallas, Texas, 75246
United States
Soma Clinical Trials
Denison, Texas, 75020
United States
South Texas Research Institute - Edinburg
Edinburg, Texas, 78539
United States
Gastro Clinic
El Paso, Texas, 79936
United States
Care United Medical Center - Forney
Forney, Texas, 75126
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
United States
Allure Health, Llc
Friendswood, Texas, 77546
United States
Digestive Health Associates of Texas - Rockwall
Garland, Texas, 75044
United States
Summitt - Pinnacle Clinical Research - Georgetown
Georgetown, Texas, 78626
United States
Advanced Medical Trials
Georgetown, Texas, 78628
United States
Houston Methodist Hospital
Houston, Texas, 77030
United States
Liver Associates of Texas
Houston, Texas, 77030
United States
Liver Specialists of Texas
Houston, Texas, 77030
United States
Liver Specialists of Texas
Houston, Texas, 77030
United States
Gastroenterology Consultants - Ellington
Houston, Texas, 77034
United States
Alpha Research Institute, LLC
Houston, Texas, 77036
United States
Houston Research Institute (HRI)
Houston, Texas, 77079
United States
Headlands - Centex Studies - Westfield
Houston, Texas, 77090
United States
Pioneer Research Solutions
Houston, Texas, 77099
United States
GI Alliance - Lubbock Digestive Disease Associates - Lubbock
Lubbock, Texas, 79410
United States
GI Alliance - Mansfield
Mansfield, Texas, 76063
United States
Koncord Research - McAllen LLC
McAllen, Texas, 78504
United States
Koncord Research-McAllen LLC
McAllen, Texas, 78504
United States
Quality Research - San Antonio
San Antonio, Texas, 78209
United States
Sun Research Institute
San Antonio, Texas, 78215
United States
Texas Liver Institute/American Research Corporation
San Antonio, Texas, 78215
United States
University of California San Diego
San Antonio, Texas, 78215
United States
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
United States
Sherman Clinical Research
Sherman, Texas, 75092
United States
Impact Research Institute
Waco, Texas, 76710
United States
Digestive Health Research of Central Texas
Waco, Texas, 76712
United States
GI Alliance - Bay Area Gastroenterology - Webster
Webster, Texas, 77598
United States
Tranquil Clinical Research
Webster, Texas, 77598
United States
Digestive Health Research of North Texas
Wichita Falls, Texas, 76301
United States
Lone Peak Family Health
Draper, Utah, 84020
United States
University of Utah School of Medicine
Salt Lake City, Utah, 84132
United States
University of Vermont Medical Center
Burlington, Vermont, 05401
United States
University of Virginia Health System
Charlottesville, Virginia, 22903
United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, 22031
United States
Inova Medical Group - Fairfax Hospital
Falls Church, Virginia, 22042
United States
Emeritas Research Group
Leesburg, Virginia, 20176
United States
Topography Health, Inc.
Manassas, Virginia, 20110
United States
Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia, 23602
United States
Digestive & Liver Disease Specialists
Norfolk, Virginia, 23502
United States
GI Select Health Research, LLC
Richmond, Virginia, 23236
United States
Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States
Liver Institute Northwest
Seattle, Washington, 98105
United States
Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Inventiva Pharma

  • Arun J Sanyal, MD, PRINCIPAL_INVESTIGATOR, VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
  • Sven Francque, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-08-19
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2021-08-19
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • Phase III
  • Nonalcoholic Steatohepatitis
  • NASH
  • Peroxisome proliferator-activated receptor (PPAR)
  • Liver Diseases
  • Fibrosis

Additional Relevant MeSH Terms

  • NASH - Nonalcoholic Steatohepatitis