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 )

Purpose

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

Condition

  • NASH - Nonalcoholic Steatohepatitis

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Male or female, aged ≥18 years at the time of signing informed consent 2. 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 3. 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 4. No qualitative change in dose for all other chronically administered drugs for at least 3 months prior to Screening 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) 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.

Exclusion Criteria

Liver-related: 1. Documented causes of chronic liver disease other than NASH 2. Histologically documented liver cirrhosis (fibrosis stage F4) 3. History or current diagnosis of hepatocellular carcinoma (HCC) 4. History of or planned liver transplant 5. Positive human immunodeficiency virus (HIV) serology 6. ALT or AST >5 × ULN 7. AST<0.6 ULN if the liver biopsy has to be performed in the scope of the study 8. Abnormal synthetic liver function as defined by Screening central laboratory evaluation 9. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males 10. Patient currently receiving any approved treatment for NASH or obesity 11. Current or recent history (<5 years) of significant alcohol consumption 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 Glycaemia related: 13. HbA1c >9% at Screening 14. Diabetes mellitus other than type 2 15. Current treatment with insulin 16. Treatment with PPAR-gamma agonists (thiazolidinediones [TZDs]) 12 months before screening or historical biopsy. Obesity related: 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. Cardiovascular related: 18. History of heart failure with reduced left ventricular ejection fraction (LVEF) 19. Atrial fibrillation requiring anticoagulation 20. Unstable heart failure 21. Uncontrolled hypertension at Screening (values >160/100 mm Hg) General safety: 22. Women currently breastfeeding 23. Previous exposure to lanifibranor 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. Concomitant treatment with PPAR-alpha agonists (fibrates)

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Pinnacle Research Group
Anniston, Alabama 36207
Contact:
Pankaj Kashyap, Doctor

Objective Health - Birmingham Gastroenterology Associates
Birmingham, Alabama 35209
Contact:
Charles Dasher, Doctor

Digestive Health Specialist of the Southeast
Dothan, Alabama 36305
Contact:
Samuel Tarwater, Doctor

North Alabama GI Research Center llc
Madison, Alabama 60602
Contact:
Jason Lockette, Doctor

The Institute For Liver Health - Chandler
Chandler, Arizona 85224-5688
Contact:
Anita Kohli, Doctor

Arizona Liver Health - Peoria
Peoria, Arizona 85381
Contact:
Ann Moore, Doctor

Saint Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
Contact:
Justin Reynolds, Doctor

Arizona Digestive Health - Sun City
Tucson, Arizona 85351
Contact:
Parag Chokshi, Droctor

Adobe Gastroenterology
Tucson, Arizona 85712
Contact:
Sam Moussa, Doctor

Arizona Liver Health
Tucson, Arizona 85712
Contact:
Naim Alkhouri, Doctor

Del Sol Research Management - Tucson East
Tucson, Arizona 85715
Contact:
Fadi Deeb, Doctor

ARcare Center for Clinical Research - Conway
Conway, Arkansas 72032
Contact:
Landon Humphrey, Doctor

ARcare Center for Clinical Research
Little Rock, Arkansas 72205
Contact:
Senthil Raghavan, Doctor

Arkansas Diagnostic Center
Little Rock, Arkansas 72205
Contact:
Alonzo Williams, Doctor

Arkansas Gastroenterology
North Little Rock, Arkansas 72117
Contact:
Scott Wofford, Doctor

Office of Franco Felizarta, MD
Bakersfield, California 93301
Contact:
Franco Felizarta, Doctor

Fomatmedicalresearch
Camarillo, California 93011
Contact:
Karen Simon, Doctor

GW Research
Chula Vista, California 91910
Contact:
Gregory Wiener, Doctor

Velocity Clinical Research, Chula Vista
Chula Vista, California 91911
Contact:
Michael Waters, Doctor

Cure Clinical Research, LLC
Fountain Valley, California 92708
Contact:
Ramprasad Dandillaya, Doctor

National Research Institute - Santa Ana
Huntington Park, California 92704
Contact:
Julie Vu, Doctor

The Clinical Trials Network - Gastro Care Institute
Lancaster, California 93534
Contact:
Kumaravel Perumalsamy, Doctor

National Research Institute - Westlake
Los Angeles, California 90057
Contact:
Leibowitz Mark, Doctor

National Research Institute - Panorama City
Panorama City, California 91402
Contact:
Robert Jenders, Doctor

California Liver Reearch
Pasadena, California 91105
Contact:
Edward Mena, MD

Cadena Care Institute
Poway, California 92064
Contact:
Kevin Merkes, Doctor

Prospective Research Innovations Inc.
Rancho Cucamonga, California 91730
Contact:
David Scarpino, Doctor

Stanford University Medical Center
Redwood City, California 94063
Contact:
Natalie Torok, Doctor

Inland Empire Liver Foundation
Rialto, California 92377
Contact:
Zeid Kayali, MD

Research and Education, Inc.
San Diego, California 92111
Contact:
Tuan Nguyen, Doctor

California Pacific Medical Center Research Institute
San Francisco, California 64107
Contact:
Raphael Merriman, Doctor

Quest Clinical Research
San Francisco, California 94115
Contact:
Maurizio Bonacini, Doctor

Silicon Valley Research Institute
San Jose, California 95128
Contact:
Huy Trinh, Doctor

Clinical Trial Management Services
Thousand Oaks, California 91360
Contact:
Mahendra Patel, Doctor

San Fernando Valley Health Institute
Van Nuys, California 91405
Contact:
Jeffrey London, Doctor

South Denver Gastroenterology - Swedish Medical Center Office
Englewood, Colorado 80113
Contact:
Marcelo Kugelmas, MD

Bridgeport Hospital
Bridgeport, Connecticut 06610
Contact:
Caroline Loeser, Doctor

Yale School of Medicine
New Haven, Connecticut 06520
Contact:
Joseph Lim, Doctor

Excel Medical Clinical Trials, LLC
Boca Raton, Florida 33434
Contact:
Seth Baum, Doctor

Synergy Healthcare
Bradenton, Florida 34208
Contact:
Patrick Weston, Doctor

Tampa Bay Medical Research
Clearwater, Florida 33761
Contact:
Sureka Bollepalli, Doctor

Gastro Florida
Clearwater, Florida 33762
Contact:
Glamour Tejinder, Doctor

Hi Tech and Global Research, LLC
Coral Gables, Florida 33134
Contact:
Jorge Beato, Doctor

Top Medical Research
Cutler Bay, Florida 33189
Contact:
Jose Ruiz, Doctor

Florida Research Institute
Lakewood Ranch, Florida 34211
Contact:
Souvik Sarkar, Doctor

Galenus Group
Lehigh Acres, Florida 33936
Contact:
Edgardo Castillo, Doctor

Florida Vascular Research
Miami, Florida 33012
Contact:
Pablo Guala, Doctor

Life Medical Research Group
Miami, Florida 33122
Contact:
Sander Fernandez, Doctor

Optimus U Corporation
Miami, Florida 33125
Contact:
Yaneicy Gonzalez Rojas, Doctor

Schiff Center for Liver Diseases
Miami, Florida 33136
Contact:
Eugene Schiff, Doctor

D&H National Research Centers
Miami, Florida 33155
Contact:
Jorge Amaya, Doctor

USPA Advance Concept Medical Research Group
Miami, Florida 33157
Contact:
Francisco Macias, Doctor

Future Care Solution
Miami, Florida 33165
Contact:
Pilar Trueba, Doctor

Genoma Research Group
Miami, Florida 33165
Contact:
Angel Vento, Doctor

Gastro Health - Galloway
Miami, Florida 33173
Contact:
Maria Hernandez, Doctor

Pro Live Medical Research
Miami, Florida 33175
Contact:
Rosa Suarez, Doctor

Miami Dade Medical Research Institute
Miami, Florida 33176
Contact:
Orlando Puente, Doctor

Advanced Research Institute
New Port Richey, Florida 34653
Contact:
Curtis Freedland, Doctor

Sensible Healthcare Clinical Research
Ocoee, Florida 34761
Contact:
William Kelly Bowman, Doctor

AdventHealth Transplant Institute
Orlando, Florida 32804
Contact:
Ayman Koteish, Doctor

Digestive and Liver Center of Florida - Orlando
Orlando, Florida 32825
Contact:
Sheela Harinath, MD

IMIC Research - International Medical Investigations Centers
Palmetto Bay, Florida 33157
Contact:
Miguel Rodriguez, Doctor

American Research Centers of Florida
Pembroke Pines, Florida 33027
Contact:
Luis del Prado Rodriguez, Doctor

Pensacola GI Research Center
Pensacola, Florida 32503
Contact:
Elizabeth Maley, Doctor

Eminat, LLC
Plantation, Florida 33317
Contact:
Yaneth Trujillo, Doctor

NAPA Research
Pompano Beach, Florida 33064
Contact:
Naval Parikh, Doctor

Covenant Metabolic Specialists LLC - Sarasota
Sarasota, Florida 34420
Contact:
Guy Neff, Doctor

Tampa General Hospital
Tampa, Florida 33606
Contact:
Nyingi Kemmer, Doctor

GI Alliance - Gastroenterology Associates of Florida - Wellington
Wellington, Florida 33414
Contact:
Lyle Hurwitz, MD

Cleveland Clinic Florida
Weston, Florida 33331
Contact:
Zaralambos Zervos, MD

Florida Medical Clinic - Zephyrhills
Zephyrhills, Florida 33542
Contact:
Tawfik Chami, MD

Athens Gastroenterology Association
Athens, Georgia 30607
Contact:
Jeffrey Williams, Doctor

Digestive Healthcare of Georgia
Atlanta, Georgia 30309
Contact:
Michael Galambos, Doctor

Oracle Clinical Research
College Park, Georgia 30349
Contact:
Linda Martinez, Doctor

IACT Health
Columbus, Georgia 31904
Contact:
Michael Steinbook, Doctor

Southeast Clinical Research Center
Dalton, Georgia 30720
Contact:
Pablo E. Perez, Doctor

Regional Infectious Diseases and Infusion Center
LaGrange, Georgia 30240
Contact:
Ravi Kamepalli, Doctor

Northwestern University
Chicago, Illinois 60611
Contact:
Amanda Cheung, MD

University of Chicago
Chicago, Illinois 60611
Contact:
Mary Rinella, MD

NorthShore University HealthSystem
Skokie, Illinois 60077
Contact:
Liana Billings, Doctor

ASHA Clinical Research - Munster
Hammond, Indiana 46324
Contact:
Mohan Kesani, Doctor

Heartland Medical Research
Clive, Iowa 50325
Contact:
Rajalakshmi Iyer, Doctor

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
Contact:
Antonio Sanchez, Doctor

Arizona Digestive Health - Sun City
Kansas City, Kansas 66160
Contact:
Parag Chokshi, Doctor

University of Kansas Medical Center Research Institute
Kansas City, Kansas 66160
Contact:
Winston Dunn, Doctor

Kansas Medical Clinic - Gastroenterology
Topeka, Kansas 66606
Contact:
Shekhar Challa, Doctor

University of Kentucky
Lexington, Kentucky 40506-0032
Contact:
Alla Grigorian, Doctor

Gastroenterology Associates - Baton Rouge
Baton Rouge, Louisiana 70809
Contact:
John McDonald, Doctor

Tandem Clinical Research GI
Houma, Louisiana 70363
Contact:
Conar Fitton, Doctor

Combined Gastro Research LLC
Lafayette, Louisiana 70503
Contact:
Stephen Abshire, Doctor

Metropolitan Gastroenterology Associates - Metairie
Metairie, Louisiana 70006
Contact:
George Catinis, Doctor

Tandem Clinical Research GI, LLC
Metairie, Louisiana 70006
Contact:
Adil Fatakia, Doctor

Louisiana Research Center LLC
Shreveport, Louisiana 71103
Contact:
Humberto Aguilar, Doctor

Investigative Clinical Research - Annapolis
Annapolis, Maryland 21401
Contact:
Epstein Michael, Doctor

Mercy Medical Center - Mcauley Plaza
Baltimore, Maryland 21202
Contact:
Paul Thuluvath, Doctor

The Johns Hopkins Hospital
Baltimore, Maryland 21287
Contact:
James Hamilton

Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
Contact:
Mohammed Ali, Doctor

Gastro Center of Maryland - Columbia
Columbia, Maryland 21045
Contact:
Rudrajit Rai, Doctor

Mid-Atlantic GI Research
Greenbelt, Maryland 20770
Contact:
Raja Mohi-ud-din, Doctor

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kathleen Corey, Doctor

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Arpan Mohanty, Doctor

Beth Israel Deaconess Medical Center - Liver Center
Boston, Massachusetts 02215
Contact:
Michelle Lai, Doctor

Clinical Research Institute of Michigan
Chesterfield, Michigan 48047
Contact:
Ronald Fogel, Doctor

Henry Ford Health System
Detroit, Michigan 48202
Contact:
Humberto Gonzalez, Doctor

Gastroenterology Associates of Western Michigan
Wyoming, Michigan 49519
Contact:
Allan Coates, Doctor

University of Michigan Health-West Hospital
Wyoming, Michigan 49519
Contact:
Ammar Hassan, Doctor

MNGI Digestive Health - Northeast Minneapolis Clinic
Minneapolis, Minnesota 55413
Contact:
Ibrahim Hanouneh, Doctor

Mayo Clinic - Rochester
Rochester, Minnesota 55905
Contact:
Harmeet Malhi, Doctor

Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood, Mississippi 39232
Contact:
Pierce Dotherow, Doctor

Galen Research
Chesterfield, Missouri 63005
Contact:
Alexander Beyzer, Doctor

Gastrointestinal (GI) Associates L.L.P.
Columbia, Missouri 65201
Contact:
Michael D. Williams, Doctor

Kansas City Research Institute
Kansas City, Missouri 64131
Contact:
Bradley Freilich, MD

SSM Health Saint Louis University Hospital
Saint Louis, Missouri 63104
Contact:
Brent Neuschwander-Tetri, Doctor

Washington University School of Medicine in St. Louis
Saint Louis, Missouri 63110
Contact:
Kevin Korenblat, Doctor

Sierra Clinical Research - Las Vegas
Las Vegas, Nevada 89106
Contact:
Vishvinder Sharma, MD

Southwest Gastroenterology Associates
Albuquerque, New Mexico 87109
Contact:
Antoine Jakiche, Doctor

State University of New York - University at Buffalo
Buffalo, New York 14203
Contact:
Ajay Chaudhuri, Doctor

Weill Cornell Medical College
New York, New York 10021
Contact:
Sonal Kumar, Doctor

Icahn School of Medicine at Mount Sinai
New York, New York 10029
Contact:
Augusto Villanueva, Doctor

Tandem Clinical Research - New York Clinic
New York, New York 10033
Contact:
Lincoln Hernandez, MD

University of Rochester Medical Center
Rochester, New York 14642
Contact:
Jonathan Huang, MD

Richmond University Medical Center
Staten Island, New York 10310
Contact:
Kavan Patel, Doctor

Charlotte Gastroenterology and Hepatology - Randolph Road Office
Charlotte, North Carolina 28207
Contact:
Jason Wilson, Doctor

ObjectiveGI - Northeast GI Research
Concord, North Carolina 28027
Contact:
Matthew Myers, Doctor

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Anna Mae Diehl, Doctor

Cumberland Research Associates
Fayetteville, North Carolina 28304
Contact:
John Poulos, Doctor

Lucas Research, Inc
Morehead City, North Carolina 28557
Contact:
Kathryn Lucas, Doctor

Gastroenterology of the Piedmont, PA - Salem Office
Winston-Salem, North Carolina 27103
Contact:
Laura Patwa, MD

Consultants for Clinical Research - Montgomery Office
Cincinnati, Ohio 45249
Contact:
Ravi Ravinuthala, Doctor

University Hospitals Case Medical Center
Cleveland, Ohio 44106
Contact:
Pierre Gholam, Doctor

The Ohio State University
Columbus, Ohio 43201
Contact:
Na Li, MD

Aventiv Research - Columbus
Columbus, Ohio 43213
Contact:
Samir Arora, Doctor

Digestive Specialists - Dayton
Dayton, Ohio 45414
Contact:
Cassandra Steimle, Doctor

Ohio Gastroenterology Group, Inc. - Olentangy Office
Dublin, Ohio 43016
Contact:
Ryan Gaible, MD

Great Lakes Gastroenterology Research - Mentor
Mentor, Ohio 44060
Contact:
Keith Friedenberg, Doctor

North Shore Gastroenterology
Westlake, Ohio 44145
Contact:
Mousab Tabbaa, Doctor

INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma 73112
Contact:
Joykumar Patel, Doctor

Options Health Research
Tulsa, Oklahoma 74104
Contact:
Harvey Tatum, Doctor

Veterans Affairs Pittsburgh Healthcare System - University Drive Campus
Pittsburgh, Pennsylvania 15240
Contact:
Obaid Shaikh, Doctor

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15261
Contact:
Jaideep Behari, Doctor

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Don Rockey, Doctor

Palmetto Clinical Research
Summerville, South Carolina 29485
Contact:
Colby Grossman, Doctor

Clinovacare Medical Clinical Research Center
West Columbia, South Carolina 29169
Contact:
Tasha Boone, MD

Gastro One - Germantown Office - Wolf Park Drive
Germantown, Tennessee 38138
Contact:
Ziad Younes, Doctor

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Andrew Scanga, Doctor

Texas Clinical Research Institute
Arlington, Texas 76012
Contact:
Reem Ghalib, Doctor

Accelemed Research Institute
Austin, Texas 78745
Contact:
Nomita Kim, Doctor

Pinnacle Clinical Research - Austin
Austin, Texas 78757
Contact:
Jacques Benun, Doctor

South Texas Research Institute - Brownsville
Brownsville, Texas 78520
Contact:
Dimple Desai, Doctor

Velocity Clinical Research - Austin
Cedar Park, Texas 78613
Contact:
Michael Zimmerman, Doctor

The Liver Institute at Methodist Dallas
Dallas, Texas 75203
Contact:
Parvez Mantry, Doctor

Liver Center of Texas
Dallas, Texas 75234
Contact:
Abdullah Mubarak, MD

GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown
Dallas, Texas 75246
Contact:
Apurva Modi, Doctor

Soma Clinical Trials
Denison, Texas 75020
Contact:
Hesham Elgouhari, Doctor

South Texas Research Institute - Edinburg
Edinburg, Texas 78539
Contact:
Rashmee Patil, Doctor

Care United Medical Center - Forney
Forney, Texas 75126
Contact:
Shilpi Mittal, Doctor

Brooke Army Medical Center
Fort Sam Houston, Texas 78234
Contact:
Johanna Hollweg, Doctor

Allure Health, Llc
Friendswood, Texas 77546
Contact:
Soto Efrain, Doctor

Digestive Health Associates of Texas - Rockwall
Garland, Texas 75044
Contact:
Harry Sarles, Doctor

Summitt - Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626
Contact:
Jacques Benun, Doctor

Advanced Medical Trials
Georgetown, Texas 78628
Contact:
Murray Snook, Doctor

Houston Methodist Hospital
Houston, Texas 77030
Contact:
David Victor, Doctor

Liver Associates of Texas
Houston, Texas 77030
Contact:
Victor Ankoma-Sey, Doctor

Liver Specialists of Texas
Houston, Texas 77030
Contact:
Joseph Galati, Doctor

Liver Specialists of Texas
Houston, Texas 77030
Contact:
Joseph Galati, MD

Gastroenterology Consultants - Ellington
Houston, Texas 77034
Contact:
Natarajan Bala, Doctor

Alpha Research Institute, LLC
Houston, Texas 77036
Contact:
Nicola Abate, Doctor

Houston Research Institute (HRI)
Houston, Texas 77079
Contact:
Mazen Noureddin, MD

Pioneer Research Solutions
Houston, Texas 77099
Contact:
Francisco Velazquez, Doctor

GI Alliance - Lubbock Digestive Disease Associates - Lubbock
Lubbock, Texas 79410
Contact:
Adam Hughston, MD

GI Alliance - Mansfield
Mansfield, Texas 76063
Contact:
Moustafa Youssef, MD

Koncord Research - McAllen LLC
McAllen, Texas 78504
Contact:
Mario Echavarria, MD

Koncord Research-McAllen LLC
McAllen, Texas 78504
Contact:
Mario Echavarria, MD

Quality Research - San Antonio
San Antonio, Texas 78209
Contact:
Robert Morin, Doctor

Sun Research Institute
San Antonio, Texas 78215
Contact:
Leonel Reyes, Doctor

Texas Liver Institute/American Research Corporation
San Antonio, Texas 78215
Contact:
Eric Lawitz, Doctor

University of California San Diego
San Antonio, Texas 78215
Contact:
Rohit Loomba, MD

Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229
Contact:
Madhavi Rudraraju, Doctor

Sherman Clinical Research
Sherman, Texas 75092
Contact:
Irfanullah Yusufzai, Doctor

Impact Research Institute
Waco, Texas 76710
Contact:
Nadege Gunn, Doctor

Digestive Health Research of Central Texas
Waco, Texas 76712
Contact:
Hanumantha Ancha, Doctor

GI Alliance - Bay Area Gastroenterology - Webster
Webster, Texas 77598
Contact:
Nikhil Inamdar, MD

Tranquil Clinical Research
Webster, Texas 77598
Contact:
Jignesh Shah, Doctor

Digestive Health Research of North Texas
Wichita Falls, Texas 76301
Contact:
Joshua Stagg, MD

Lone Peak Family Health
Draper, Utah 84020
Contact:
David Jack, Doctor

University of Utah School of Medicine
Salt Lake City, Utah 84132
Contact:
Juan Gallegos-Orozco, Doctor

University of Vermont Medical Center
Burlington, Vermont 05401
Contact:
Steven Lidofsky, MD

University of Virginia Health System
Charlottesville, Virginia 22903
Contact:
Stephen Caldwell, Doctor

Gastroenterology Associates of Northern Virginia
Fairfax, Virginia 22031
Contact:
Bezawit Tekola, Doctor

Inova Medical Group - Fairfax Hospital
Falls Church, Virginia 22042
Contact:
Stephen Clement, Doctor

Topography Health, Inc.
Manassas, Virginia 20110
Contact:
Myung Choi, Doctor

Bon Secours Liver Institute of Hampton Roads
Newport News, Virginia 23602
Contact:
Mitchell Shiffman, Doctor

Digestive & Liver Disease Specialists
Norfolk, Virginia 23502
Contact:
Alan Tieu, Doctor

GI Select Health Research, LLC
Richmond, Virginia 23236
Contact:
Omer Khalid, Doctor

Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond
Richmond, Virginia 23249
Contact:
Michael Fuchs, MD

Virginia Commonwealth University
Richmond, Virginia 23284
Contact:
Velimir Luketic, Doctor

Liver Institute Northwest
Seattle, Washington 98105
Contact:
Kris Kowdley, MD

Froedtert and Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Contact:
Kia Saeian, MD

Fundación de Investigación de Diego Clinical Research
San Juan, Puerto Rico 00927
Contact:
Grisell Ortiz-Lasanta, Doctor

More Details

NCT ID
NCT04849728
Status
Recruiting
Sponsor
Inventiva Pharma

Study Contact

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

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)

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center