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 Sex
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 4830198, Alabama 4829764 36207
Contact:
Pankaj Kashyap, Doctor

Objective Health - Birmingham Gastroenterology Associates
Birmingham 4049979, Alabama 4829764 35209
Contact:
Charles Dasher, Doctor

Digestive Health Specialist of the Southeast
Dothan 4059102, Alabama 4829764 36305
Contact:
Samuel Tarwater, Doctor

North Alabama GI Research Center llc
Madison 4074267, Alabama 4829764 60602
Contact:
Jason Lockette, Doctor

The Institute For Liver Health - Chandler
Chandler 5289282, Arizona 5551752 85224-5688
Contact:
Anita Kohli, Doctor

Arizona Liver Health - Peoria
Peoria 5308480, Arizona 5551752 85381
Contact:
Ann Moore, Doctor

Saint Joseph's Hospital and Medical Center
Phoenix 5308655, Arizona 5551752 85013
Contact:
Justin Reynolds, Doctor

Arizona Digestive Health - Sun City
Tucson 5318313, Arizona 5551752 85351
Contact:
Parag Chokshi, Droctor

Adobe Gastroenterology
Tucson 5318313, Arizona 5551752 85712
Contact:
Sam Moussa, Doctor

Arizona Liver Health
Tucson 5318313, Arizona 5551752 85712
Contact:
Naim Alkhouri, Doctor

Del Sol Research Management - Tucson East
Tucson 5318313, Arizona 5551752 85715
Contact:
Fadi Deeb, Doctor

ARcare Center for Clinical Research - Conway
Conway 4106458, Arkansas 4099753 72032
Contact:
Landon Humphrey, Doctor

ARcare Center for Clinical Research
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Senthil Raghavan, Doctor

Arkansas Diagnostic Center
Little Rock 4119403, Arkansas 4099753 72205
Contact:
Alonzo Williams, Doctor

Arkansas Gastroenterology
North Little Rock 4124112, Arkansas 4099753 72117
Contact:
Scott Wofford, Doctor

Office of Franco Felizarta, MD
Bakersfield 5325738, California 5332921 93301
Contact:
Franco Felizarta, Doctor

Fomatmedicalresearch
Camarillo 5333180, California 5332921 93011
Contact:
Karen Simon, Doctor

GW Research
Chula Vista 5336899, California 5332921 91910
Contact:
Gregory Wiener, Doctor

Velocity Clinical Research, Chula Vista
Chula Vista 5336899, California 5332921 91911
Contact:
Michael Waters, Doctor

Cure Clinical Research, LLC
Fountain Valley 5350207, California 5332921 92708
Contact:
Ramprasad Dandillaya, Doctor

National Research Institute - Santa Ana
Huntington Park 5358736, California 5332921 92704
Contact:
Julie Vu, Doctor

The Clinical Trials Network - Gastro Care Institute
Lancaster 5364940, California 5332921 93534
Contact:
Kumaravel Perumalsamy, Doctor

National Research Institute - Westlake
Los Angeles 5368361, California 5332921 90057
Contact:
Leibowitz Mark, Doctor

National Research Institute - Panorama City
Panorama City 5380932, California 5332921 91402
Contact:
Robert Jenders, Doctor

California Liver Reearch
Pasadena 5381396, California 5332921 91105
Contact:
Edward Mena, MD

Cadena Care Institute
Poway 5384690, California 5332921 92064
Contact:
Kevin Merkes, Doctor

Prospective Research Innovations Inc.
Rancho Cucamonga 5385955, California 5332921 91730
Contact:
David Scarpino, Doctor

Stanford University Medical Center
Redwood City 5386834, California 5332921 94063
Contact:
Natalie Torok, Doctor

Inland Empire Liver Foundation
Rialto 5387288, California 5332921 92377
Contact:
Zeid Kayali, MD

Research and Education, Inc.
San Diego 5391811, California 5332921 92111
Contact:
Tuan Nguyen, Doctor

California Pacific Medical Center Research Institute
San Francisco 5391959, California 5332921 64107
Contact:
Raphael Merriman, Doctor

Quest Clinical Research
San Francisco 5391959, California 5332921 94115
Contact:
Maurizio Bonacini, Doctor

Silicon Valley Research Institute
San Jose 5392171, California 5332921 95128
Contact:
Huy Trinh, Doctor

Clinical Trial Management Services
Thousand Oaks 5402405, California 5332921 91360
Contact:
Mahendra Patel, Doctor

San Fernando Valley Health Institute
Van Nuys 5405693, California 5332921 91405
Contact:
Jeffrey London, Doctor

South Denver Gastroenterology - Swedish Medical Center Office
Englewood 5421250, Colorado 5417618 80113
Contact:
Marcelo Kugelmas, MD

Bridgeport Hospital
Bridgeport 5282804, Connecticut 4831725 06610
Contact:
Caroline Loeser, Doctor

Yale School of Medicine
New Haven 4839366, Connecticut 4831725 06520
Contact:
Joseph Lim, Doctor

Excel Medical Clinical Trials, LLC
Boca Raton 4148411, Florida 4155751 33434
Contact:
Seth Baum, Doctor

Synergy Healthcare
Bradenton 4148708, Florida 4155751 34208
Contact:
Patrick Weston, Doctor

Tampa Bay Medical Research
Clearwater 4151316, Florida 4155751 33761
Contact:
Sureka Bollepalli, Doctor

Gastro Florida
Clearwater 4151316, Florida 4155751 33762
Contact:
Glamour Tejinder, Doctor

Hi Tech and Global Research, LLC
Coral Gables 4151871, Florida 4155751 33134
Contact:
Jorge Beato, Doctor

Top Medical Research
Cutler Bay 6332309, Florida 4155751 33189
Contact:
Jose Ruiz, Doctor

Florida Research Institute
Lakewood Rch 7255365, Florida 4155751 34211
Contact:
Souvik Sarkar, Doctor

Galenus Group
Lehigh Acres 4161785, Florida 4155751 33936
Contact:
Edgardo Castillo, Doctor

Florida Vascular Research
Miami 4164138, Florida 4155751 33012
Contact:
Pablo Guala, Doctor

Life Medical Research Group
Miami 4164138, Florida 4155751 33122
Contact:
Sander Fernandez, Doctor

Optimus U Corporation
Miami 4164138, Florida 4155751 33125
Contact:
Yaneicy Gonzalez Rojas, Doctor

Schiff Center for Liver Diseases
Miami 4164138, Florida 4155751 33136
Contact:
Eugene Schiff, Doctor

D&H National Research Centers
Miami 4164138, Florida 4155751 33155
Contact:
Jorge Amaya, Doctor

USPA Advance Concept Medical Research Group
Miami 4164138, Florida 4155751 33157
Contact:
Francisco Macias, Doctor

Future Care Solution
Miami 4164138, Florida 4155751 33165
Contact:
Pilar Trueba, Doctor

Genoma Research Group
Miami 4164138, Florida 4155751 33165
Contact:
Angel Vento, Doctor

Gastro Health - Galloway
Miami 4164138, Florida 4155751 33173
Contact:
Maria Hernandez, Doctor

Pro Live Medical Research
Miami 4164138, Florida 4155751 33175
Contact:
Rosa Suarez, Doctor

Miami Dade Medical Research Institute
Miami 4164138, Florida 4155751 33176
Contact:
Orlando Puente, Doctor

Advanced Research Institute
New Port Richey 4165869, Florida 4155751 34653
Contact:
Curtis Freedland, Doctor

Sensible Healthcare Clinical Research
Ocoee 4166776, Florida 4155751 34761
Contact:
William Kelly Bowman, Doctor

AdventHealth Transplant Institute
Orlando 4167147, Florida 4155751 32804
Contact:
Ayman Koteish, Doctor

Digestive and Liver Center of Florida - Orlando
Orlando 4167147, Florida 4155751 32825
Contact:
Sheela Harinath, MD

IMIC Research - International Medical Investigations Centers
Palmetto Bay 4167634, Florida 4155751 33157
Contact:
Miguel Rodriguez, Doctor

American Research Centers of Florida
Pembroke Pines 4168139, Florida 4155751 33027
Contact:
Luis del Prado Rodriguez, Doctor

Pensacola GI Research Center
Pensacola 4168228, Florida 4155751 32503
Contact:
Elizabeth Maley, Doctor

Eminat, LLC
Plantation 4168782, Florida 4155751 33317
Contact:
Yaneth Trujillo, Doctor

NAPA Research
Pompano Beach 4169014, Florida 4155751 33064
Contact:
Naval Parikh, Doctor

Covenant Metabolic Specialists LLC - Sarasota
Sarasota 4172131, Florida 4155751 34420
Contact:
Guy Neff, Doctor

Tampa General Hospital
Tampa 4174757, Florida 4155751 33606
Contact:
Nyingi Kemmer, Doctor

GI Alliance - Gastroenterology Associates of Florida - Wellington
Wellington 4177703, Florida 4155751 33414
Contact:
Lyle Hurwitz, MD

Cleveland Clinic Florida
Weston 4178003, Florida 4155751 33331
Contact:
Zaralambos Zervos, MD

Florida Medical Clinic - Zephyrhills
Zephyrhills 4178941, Florida 4155751 33542
Contact:
Tawfik Chami, MD

Athens Gastroenterology Association
Athens 4180386, Georgia 4197000 30607
Contact:
Jeffrey Williams, Doctor

Digestive Healthcare of Georgia
Atlanta 4180439, Georgia 4197000 30309
Contact:
Michael Galambos, Doctor

Oracle Clinical Research
College Park 4188815, Georgia 4197000 30349
Contact:
Linda Martinez, Doctor

IACT Health
Columbus 4188985, Georgia 4197000 31904
Contact:
Michael Steinbook, Doctor

Southeast Clinical Research Center
Dalton 4190581, Georgia 4197000 30720
Contact:
Pablo E. Perez, Doctor

Regional Infectious Diseases and Infusion Center
La Grange 4204230, Georgia 4197000 30240
Contact:
Ravi Kamepalli, Doctor

Northwestern University
Chicago 4887398, Illinois 4896861 60611
Contact:
Amanda Cheung, MD

University of Chicago
Chicago 4887398, Illinois 4896861 60611
Contact:
Mary Rinella, MD

NorthShore University HealthSystem
Skokie 4911600, Illinois 4896861 60077
Contact:
Liana Billings, Doctor

ASHA Clinical Research - Munster
Hammond 4921100, Indiana 4921868 46324
Contact:
Mohan Kesani, Doctor

Heartland Medical Research
Clive 4852065, Iowa 4862182 50325
Contact:
Rajalakshmi Iyer, Doctor

University of Iowa Hospitals and Clinics
Iowa City 4862034, Iowa 4862182 52242
Contact:
Antonio Sanchez, Doctor

Arizona Digestive Health - Sun City
Kansas City 4273837, Kansas 4273857 66160
Contact:
Parag Chokshi, Doctor

University of Kansas Medical Center Research Institute
Kansas City 4273837, Kansas 4273857 66160
Contact:
Winston Dunn, Doctor

Kansas Medical Clinic - Gastroenterology
Topeka 4280539, Kansas 4273857 66606
Contact:
Shekhar Challa, Doctor

University of Kentucky
Lexington 4297983, Kentucky 6254925 40506-0032
Contact:
Alla Grigorian, Doctor

Gastroenterology Associates - Baton Rouge
Baton Rouge 4315588, Louisiana 4331987 70809
Contact:
John McDonald, Doctor

Tandem Clinical Research GI
Houma 4328010, Louisiana 4331987 70363
Contact:
Conar Fitton, Doctor

Combined Gastro Research LLC
Lafayette 4330145, Louisiana 4331987 70503
Contact:
Stephen Abshire, Doctor

Metropolitan Gastroenterology Associates - Metairie
Metairie 4333177, Louisiana 4331987 70006
Contact:
George Catinis, Doctor

Tandem Clinical Research GI, LLC
Metairie 4333177, Louisiana 4331987 70006
Contact:
Adil Fatakia, Doctor

Louisiana Research Center LLC
Shreveport 4341513, Louisiana 4331987 71103
Contact:
Humberto Aguilar, Doctor

Investigative Clinical Research - Annapolis
Annapolis 4347242, Maryland 4361885 21401
Contact:
Epstein Michael, Doctor

Mercy Medical Center - Mcauley Plaza
Baltimore 4347778, Maryland 4361885 21202
Contact:
Paul Thuluvath, Doctor

The Johns Hopkins Hospital
Baltimore 4347778, Maryland 4361885 21287
Contact:
James Hamilton

Chevy Chase Clinical Research
Chevy Chase 4351335, Maryland 4361885 20815
Contact:
Mohammed Ali, Doctor

Gastro Center of Maryland - Columbia
Columbia 4352053, Maryland 4361885 21045
Contact:
Rudrajit Rai, Doctor

Mid-Atlantic GI Research
Greenbelt 4356847, Maryland 4361885 20770
Contact:
Raja Mohi-ud-din, Doctor

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Kathleen Corey, Doctor

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Contact:
Arpan Mohanty, Doctor

Beth Israel Deaconess Medical Center - Liver Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Michelle Lai, Doctor

Clinical Research Institute of Michigan
Chesterfield 4988681, Michigan 5001836 48047
Contact:
Ronald Fogel, Doctor

Henry Ford Health System
Detroit 4990729, Michigan 5001836 48202
Contact:
Humberto Gonzalez, Doctor

Gastroenterology Associates of Western Michigan
Wyoming 5015618, Michigan 5001836 49519
Contact:
Allan Coates, Doctor

University of Michigan Health-West Hospital
Wyoming 5015618, Michigan 5001836 49519
Contact:
Ammar Hassan, Doctor

MNGI Digestive Health - Northeast Minneapolis Clinic
Minneapolis 5037649, Minnesota 5037779 55413
Contact:
Ibrahim Hanouneh, Doctor

Mayo Clinic - Rochester
Rochester 5043473, Minnesota 5037779 55905
Contact:
Harmeet Malhi, Doctor

Gastrointestinal Associates & Endoscopy Center - Flowood
Flowood 4426822, Mississippi 4436296 39232
Contact:
Pierce Dotherow, Doctor

Galen Research
Chesterfield 4381072, Missouri 4398678 63005
Contact:
Alexander Beyzer, Doctor

Gastrointestinal (GI) Associates L.L.P.
Columbia 4381982, Missouri 4398678 65201
Contact:
Michael D. Williams, Doctor

Kansas City Research Institute
Kansas City 4393217, Missouri 4398678 64131
Contact:
Bradley Freilich, MD

SSM Health Saint Louis University Hospital
St Louis 4407066, Missouri 4398678 63104
Contact:
Brent Neuschwander-Tetri, Doctor

Washington University School of Medicine in St. Louis
St Louis 4407066, Missouri 4398678 63110
Contact:
Kevin Korenblat, Doctor

Sierra Clinical Research - Las Vegas
Las Vegas 5506956, Nevada 5509151 89106
Contact:
Vishvinder Sharma, MD

Southwest Gastroenterology Associates
Albuquerque 5454711, New Mexico 5481136 87109
Contact:
Antoine Jakiche, Doctor

State University of New York - University at Buffalo
Buffalo 5110629, New York 5128638 14203
Contact:
Ajay Chaudhuri, Doctor

Weill Cornell Medical College
New York 5128581, New York 5128638 10021
Contact:
Sonal Kumar, Doctor

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029
Contact:
Augusto Villanueva, Doctor

Tandem Clinical Research - New York Clinic
New York 5128581, New York 5128638 10033
Contact:
Lincoln Hernandez, MD

University of Rochester Medical Center
Rochester 5134086, New York 5128638 14642
Contact:
Jonathan Huang, MD

Richmond University Medical Center
Staten Island 5139568, New York 5128638 10310
Contact:
Kavan Patel, Doctor

Charlotte Gastroenterology and Hepatology - Randolph Road Office
Charlotte 4460243, North Carolina 4482348 28207
Contact:
Jason Wilson, Doctor

ObjectiveGI - Northeast GI Research
Concord 4461574, North Carolina 4482348 28027
Contact:
Matthew Myers, Doctor

Duke University Medical Center
Durham 4464368, North Carolina 4482348 27710
Contact:
Anna Mae Diehl, Doctor

Cumberland Research Associates
Fayetteville 4466033, North Carolina 4482348 28304
Contact:
John Poulos, Doctor

Lucas Research, Inc
Morehead City 4480153, North Carolina 4482348 28557
Contact:
Kathryn Lucas, Doctor

Gastroenterology of the Piedmont, PA - Salem Office
Winston-Salem 4499612, North Carolina 4482348 27103
Contact:
Laura Patwa, MD

Consultants for Clinical Research - Montgomery Office
Cincinnati 4508722, Ohio 5165418 45249
Contact:
Ravi Ravinuthala, Doctor

University Hospitals Case Medical Center
Cleveland 5150529, Ohio 5165418 44106
Contact:
Pierre Gholam, Doctor

The Ohio State University
Columbus 4509177, Ohio 5165418 43201
Contact:
Na Li, MD

Aventiv Research - Columbus
Columbus 4509177, Ohio 5165418 43213
Contact:
Samir Arora, Doctor

Digestive Specialists - Dayton
Dayton 4509884, Ohio 5165418 45414
Contact:
Cassandra Steimle, Doctor

Ohio Gastroenterology Group, Inc. - Olentangy Office
Dublin 5152333, Ohio 5165418 43016
Contact:
Ryan Gaible, MD

Great Lakes Gastroenterology Research - Mentor
Mentor 5162645, Ohio 5165418 44060
Contact:
Keith Friedenberg, Doctor

North Shore Gastroenterology
Westlake 5176517, Ohio 5165418 44145
Contact:
Mousab Tabbaa, Doctor

INTEGRIS Baptist Medical Center
Oklahoma City 4544349, Oklahoma 4544379 73112
Contact:
Joykumar Patel, Doctor

Options Health Research
Tulsa 4553433, Oklahoma 4544379 74104
Contact:
Harvey Tatum, Doctor

Veterans Affairs Pittsburgh Healthcare System - University Drive Campus
Pittsburgh 5206379, Pennsylvania 6254927 15240
Contact:
Obaid Shaikh, Doctor

University of Pittsburgh Medical Center
Pittsburgh 5206379, Pennsylvania 6254927 15261
Contact:
Jaideep Behari, Doctor

Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Contact:
Don Rockey, Doctor

Palmetto Clinical Research
Summerville 4597919, South Carolina 4597040 29485
Contact:
Colby Grossman, Doctor

Clinovacare Medical Clinical Research Center
West Columbia 4600541, South Carolina 4597040 29169
Contact:
Tasha Boone, MD

Gastro One - Germantown Office - Wolf Park Drive
Germantown 4624601, Tennessee 4662168 38138
Contact:
Ziad Younes, Doctor

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Andrew Scanga, Doctor

Texas Clinical Research Institute
Arlington 4671240, Texas 4736286 76012
Contact:
Reem Ghalib, Doctor

Accelemed Research Institute
Austin 4671654, Texas 4736286 78745
Contact:
Nomita Kim, Doctor

Pinnacle Clinical Research - Austin
Austin 4671654, Texas 4736286 78757
Contact:
Jacques Benun, Doctor

South Texas Research Institute - Brownsville
Brownsville 4676740, Texas 4736286 78520
Contact:
Dimple Desai, Doctor

Velocity Clinical Research - Austin
Cedar Park 4679867, Texas 4736286 78613
Contact:
Michael Zimmerman, Doctor

The Liver Institute at Methodist Dallas
Dallas 4684888, Texas 4736286 75203
Contact:
Parvez Mantry, Doctor

Liver Center of Texas
Dallas 4684888, Texas 4736286 75234
Contact:
Abdullah Mubarak, MD

GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown
Dallas 4684888, Texas 4736286 75246
Contact:
Apurva Modi, Doctor

Soma Clinical Trials
Denison 4685892, Texas 4736286 75020
Contact:
Hesham Elgouhari, Doctor

South Texas Research Institute - Edinburg
Edinburg 4688275, Texas 4736286 78539
Contact:
Rashmee Patil, Doctor

Care United Medical Center - Forney
Forney 4691833, Texas 4736286 75126
Contact:
Shilpi Mittal, Doctor

Brooke Army Medical Center
Fort Sam Houston 7267736, Texas 4736286 78234
Contact:
Johanna Hollweg, Doctor

Allure Health, Llc
Friendswood 4692521, Texas 4736286 77546
Contact:
Soto Efrain, Doctor

Digestive Health Associates of Texas - Rockwall
Garland 4693003, Texas 4736286 75044
Contact:
Harry Sarles, Doctor

Summitt - Pinnacle Clinical Research - Georgetown
Georgetown 4693342, Texas 4736286 78626
Contact:
Jacques Benun, Doctor

Advanced Medical Trials
Georgetown 4693342, Texas 4736286 78628
Contact:
Murray Snook, Doctor

Houston Methodist Hospital
Houston 4699066, Texas 4736286 77030
Contact:
David Victor, Doctor

Liver Associates of Texas
Houston 4699066, Texas 4736286 77030
Contact:
Victor Ankoma-Sey, Doctor

Liver Specialists of Texas
Houston 4699066, Texas 4736286 77030
Contact:
Joseph Galati, Doctor

Liver Specialists of Texas
Houston 4699066, Texas 4736286 77030
Contact:
Joseph Galati, MD

Gastroenterology Consultants - Ellington
Houston 4699066, Texas 4736286 77034
Contact:
Natarajan Bala, Doctor

Alpha Research Institute, LLC
Houston 4699066, Texas 4736286 77036
Contact:
Nicola Abate, Doctor

Houston Research Institute (HRI)
Houston 4699066, Texas 4736286 77079
Contact:
Mazen Noureddin, MD

Pioneer Research Solutions
Houston 4699066, Texas 4736286 77099
Contact:
Francisco Velazquez, Doctor

GI Alliance - Lubbock Digestive Disease Associates - Lubbock
Lubbock 5525577, Texas 4736286 79410
Contact:
Adam Hughston, MD

GI Alliance - Mansfield
Mansfield 4709013, Texas 4736286 76063
Contact:
Moustafa Youssef, MD

Koncord Research - McAllen LLC
McAllen 4709796, Texas 4736286 78504
Contact:
Mario Echavarria, MD

Koncord Research-McAllen LLC
McAllen 4709796, Texas 4736286 78504
Contact:
Mario Echavarria, MD

Quality Research - San Antonio
San Antonio 4726206, Texas 4736286 78209
Contact:
Robert Morin, Doctor

Sun Research Institute
San Antonio 4726206, Texas 4736286 78215
Contact:
Leonel Reyes, Doctor

Texas Liver Institute/American Research Corporation
San Antonio 4726206, Texas 4736286 78215
Contact:
Eric Lawitz, Doctor

University of California San Diego
San Antonio 4726206, Texas 4736286 78215
Contact:
Rohit Loomba, MD

Pinnacle Clinical Research - San Antonio
San Antonio 4726206, Texas 4736286 78229
Contact:
Madhavi Rudraraju, Doctor

Sherman Clinical Research
Sherman 4728328, Texas 4736286 75092
Contact:
Irfanullah Yusufzai, Doctor

Impact Research Institute
Waco 4739526, Texas 4736286 76710
Contact:
Nadege Gunn, Doctor

Digestive Health Research of Central Texas
Waco 4739526, Texas 4736286 76712
Contact:
Hanumantha Ancha, Doctor

GI Alliance - Bay Area Gastroenterology - Webster
Webster 4740423, Texas 4736286 77598
Contact:
Nikhil Inamdar, MD

Tranquil Clinical Research
Webster 4740423, Texas 4736286 77598
Contact:
Jignesh Shah, Doctor

Digestive Health Research of North Texas
Wichita Falls 4741752, Texas 4736286 76301
Contact:
Joshua Stagg, MD

Lone Peak Family Health
Draper 5774001, Utah 5549030 84020
Contact:
David Jack, Doctor

University of Utah School of Medicine
Salt Lake City 5780993, Utah 5549030 84132
Contact:
Juan Gallegos-Orozco, Doctor

University of Vermont Medical Center
Burlington 5234372, Vermont 5242283 05401
Contact:
Steven Lidofsky, MD

University of Virginia Health System
Charlottesville 4752031, Virginia 6254928 22903
Contact:
Stephen Caldwell, Doctor

Gastroenterology Associates of Northern Virginia
Fairfax 4758023, Virginia 6254928 22031
Contact:
Bezawit Tekola, Doctor

Inova Medical Group - Fairfax Hospital
Falls Church 4758390, Virginia 6254928 22042
Contact:
Stephen Clement, Doctor

Topography Health, Inc.
Manassas 4771401, Virginia 6254928 20110
Contact:
Myung Choi, Doctor

Bon Secours Liver Institute of Hampton Roads
Newport News 4776024, Virginia 6254928 23602
Contact:
Mitchell Shiffman, Doctor

Digestive & Liver Disease Specialists
Norfolk 4776222, Virginia 6254928 23502
Contact:
Alan Tieu, Doctor

GI Select Health Research, LLC
Richmond 4781708, Virginia 6254928 23236
Contact:
Omer Khalid, Doctor

Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond
Richmond 4781708, Virginia 6254928 23249
Contact:
Michael Fuchs, MD

Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23284
Contact:
Velimir Luketic, Doctor

Liver Institute Northwest
Seattle 5809844, Washington 5815135 98105
Contact:
Kris Kowdley, MD

Froedtert and Medical College of Wisconsin
Milwaukee 5263045, Wisconsin 5279468 53226
Contact:
Kia Saeian, MD

Fundación de Investigación de Diego Clinical Research
San Juan 4568127, 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)

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