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 )

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Inventiva Pharma
Study ID
NCT04849728
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IVA337 — DRUG
    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.
  • Placebo — DRUG
    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 Details

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

Key Dates

First listed
Apr 19, 2021
Start date
Aug 19, 2021
Status verified
Mar 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
1,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Lanifibranor (IVA 337) (800 mg/day)
    2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --\> once a day (quaque die, QD)
  • Experimental: Lanifibranor (IVA 337) (1200 mg/day)
    3 Lanifibranor tablets 400mg with food --\> once a day (quaque die, QD)
  • Placebo Comparator: Matching placebo
    3 Placebo to match tablets with food --\> once a day (quaque die, QD)

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 ]

Locations (194)

FacilityCityStateZIPSite coordinators
Objective Health - Birmingham Gastroenterology AssociatesBirminghamAlabama35209-
Digestive Health Specialist of the SoutheastDothanAlabama36305-
North Alabama GI Research Center llcMadisonAlabama60602-
The Institute For Liver Health - ChandlerChandlerArizona85224-5688-
Arizona Liver Health - PeoriaPeoriaArizona85381-
Dignity Health - St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
Saint Joseph's Hospital and Medical CenterPhoenixArizona85013-
Adobe GastroenterologyTucsonArizona85712-
Arizona Liver HealthTucsonArizona85712-
ARcare Center for Clinical Research - ConwayConwayArkansas72032-
ARcare Center for Clinical ResearchLittle RockArkansas72205-
Arkansas Diagnostic CenterLittle RockArkansas72205-
Arkansas GastroenterologyNorth Little RockArkansas72117-
Summit - Arkansas GastroenterologyNorth Little RockArkansas72117-
FomatmedicalresearchCamarilloCalifornia93011-
GW ResearchChula VistaCalifornia91910-
Velocity Clinical Research, Chula VistaChula VistaCalifornia91911-
TriWest Research AssociatesEl CajonCalifornia92020-
Cure Clinical Research, LLCFountain ValleyCalifornia92708-
SC Clinical ResearchGarden GroveCalifornia92844-
Velocity Clinical Research - GardenaGardenaCalifornia90247-
National Research Institute - Santa AnaHuntington ParkCalifornia92704-
The Clinical Trials Network - Gastro Care InstituteLancasterCalifornia93534-
National Research Institute - WestlakeLos AngelesCalifornia90057-
National Research Institute - Panorama CityPanorama CityCalifornia91402-
California Liver ReearchPasadenaCalifornia91105-
Cadena Care InstitutePowayCalifornia92064-
Stanford University Medical CenterRedwood CityCalifornia94063-
Research and Education, Inc.San DiegoCalifornia92111-
California Pacific Medical Center Research InstituteSan FranciscoCalifornia64107-
Quest Clinical ResearchSan FranciscoCalifornia94115-
Silicon Valley Research InstituteSan JoseCalifornia95128-
Clinical Trial Management ServicesThousand OaksCalifornia91360-
San Fernando Valley Health InstituteVan NuysCalifornia91405-
South Denver Gastroenterology - Swedish Medical Center OfficeEnglewoodColorado80113-
Yale School of MedicineNew HavenConnecticut06520-
Florida Research InstituteBradentonFlorida34209-
Synergy HealthcareBradentonFlorida34208-
Gastro FloridaClearwaterFlorida33762-
Tampa Bay Medical ResearchClearwaterFlorida33761-
Hi Tech and Global Research, LLCCoral GablesFlorida33134-
JY Research Institute Inc.Cutler BayFlorida33189-
Top Medical ResearchCutler BayFlorida33189-
Doral Medical Research, LLCHialeahFlorida33016-
Palmetto ResearchHialeahFlorida33016-
Florida Research InstituteLakewood RchFlorida34211-
Galenus GroupLehigh AcresFlorida33936-
Accel Research SitesMaitlandFlorida32751-
Centor for Advanced Gastroenterology - Main Office - MaitlandMaitlandFlorida32751-
Clinical Trials Services CorporationMiamiFlorida33181-
D&H National Research CentersMiamiFlorida33155-
Florida Vascular ResearchMiamiFlorida33012-
Future Care SolutionMiamiFlorida33165-
Gastro Health - GallowayMiamiFlorida33173-
Genoma Research GroupMiamiFlorida33165-
Life Medical Research GroupMiamiFlorida33122-
Miami Dade Medical Research InstituteMiamiFlorida33176-
Pro Live Medical ResearchMiamiFlorida33175-
Schiff Center for Liver DiseasesMiamiFlorida33136-
Advanced Research InstituteNew Port RicheyFlorida34653-
Sensible Healthcare Clinical ResearchOcoeeFlorida34761-
AdventHealth Transplant InstituteOrlandoFlorida32804-
Digestive and Liver Center of Florida - OrlandoOrlandoFlorida32825-
IMIC Research - International Medical Investigations CentersPalmetto BayFlorida33157-
American Research Centers of FloridaPembroke PinesFlorida33027-
Pensacola GI Research CenterPensacolaFlorida32503-
Eminat, LLCPlantationFlorida33317-
D & H Pompano Research CenterPompano BeachFlorida33064-
NAPA ResearchPompano BeachFlorida33064-
Covenant Metabolic Specialists LLC - SarasotaSarasotaFlorida34420-
Tampa General HospitalTampaFlorida33606-
Cleveland Clinic FloridaWestonFlorida33331-
Florida Medical Clinic - ZephyrhillsZephyrhillsFlorida33542-
Digestive Healthcare of GeorgiaAtlantaGeorgia30309-
Oracle Clinical ResearchCollege ParkGeorgia30349-
IACT HealthColumbusGeorgia31904-
Southeast Clinical Research CenterDaltonGeorgia30720-
Grand Teton Research Group, PLLCIdaho FallsIdaho83404-
Northwestern UniversityChicagoIllinois60611-
University of ChicagoChicagoIllinois60611-
NorthShore University HealthSystemSkokieIllinois60077-
ASHA Clinical Research - MunsterHammondIndiana46324-
Heartland Medical ResearchCliveIowa50325-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Arizona Digestive Health - Sun CityKansas CityKansas66160-
University of Kansas Medical Center Research InstituteKansas CityKansas66160-
Kansas Medical Clinic - GastroenterologyTopekaKansas66606-
University of KentuckyLexingtonKentucky40506-0032-
Tandem Clinical Research GIHoumaLouisiana70363-
Combined Gastro Research LLCLafayetteLouisiana70503-
Tandem Clinical ResearchMarreroLouisiana70072-
Metropolitan Gastroenterology Associates - MetairieMetairieLouisiana70006-
Louisiana Research Center LLCShreveportLouisiana71103-
Mercy Medical Center - Mcauley PlazaBaltimoreMaryland21202-
The Johns Hopkins HospitalBaltimoreMaryland21287-
Digestive Disease Associates - CatonsvilleCatonsvilleMaryland21228-
Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Mid-Atlantic GI ResearchGreenbeltMaryland20770-
Meritus Center for Clinical ResearchHagerstownMaryland21742-
Beth Israel Deaconess Medical Center - Liver CenterBostonMassachusetts02215-
Boston Medical CenterBostonMassachusetts02118-
Massachusetts General HospitalBostonMassachusetts02114-
NECCR Prima Care Research, LLCFall RiverMassachusetts02721-
Clinical Research Institute of MichiganChesterfieldMichigan48047-
Henry Ford Health SystemDetroitMichigan48202-
Gastroenterology Associates of Western MichiganWyomingMichigan49519-
MNGI Digestive Health - Northeast Minneapolis ClinicMinneapolisMinnesota55413-
Mayo Clinic - RochesterRochesterMinnesota55905-
Gastrointestinal Associates & Endoscopy Center - FlowoodFlowoodMississippi39232-
Galen ResearchChesterfieldMissouri63005-
Gastrointestinal (GI) Associates L.L.P.ColumbiaMissouri65201-
Kansas City Research InstituteKansas CityMissouri64131-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Sierra Clinical Research - Las VegasLas VegasNevada89106-
Southwest Gastroenterology AssociatesAlbuquerqueNew Mexico87109-
State University of New York - University at BuffaloBuffaloNew York14203-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
New York University Langone Gastroenterology AssociatesNew YorkNew York10016-
Tandem Clinical Research - New York ClinicNew YorkNew York10033-
Weill Cornell Medical CollegeNew YorkNew York10021-
University of Rochester Medical CenterRochesterNew York14642-
Richmond University Medical CenterStaten IslandNew York10310-
Charlotte Gastroenterology and Hepatology - Randolph Road OfficeCharlotteNorth Carolina28207-
Duke University Medical CenterDurhamNorth Carolina27710-
Icahn School of Medicine at Mount SinaiDurhamNorth Carolina27710-
Cumberland Research AssociatesFayettevilleNorth Carolina28304-
Carolina Digestive DiseasesGreenvilleNorth Carolina27834-
Lucas Research, IncMorehead CityNorth Carolina28557-
Gastroenterology of the Piedmont, PA - Salem OfficeWinston-SalemNorth Carolina27103-
Consultants for Clinical Research - Montgomery OfficeCincinnatiOhio45249-
University Hospitals Case Medical CenterClevelandOhio44106-
Aventiv Research - ColumbusColumbusOhio43213-
Centricity (Aventiv) Research - ColumbusColumbusOhio43213-
The Ohio State UniversityColumbusOhio43201-
Digestive Specialists - DaytonDaytonOhio45414-
Ohio Gastroenterology Group, Inc. - Olentangy OfficeDublinOhio43016-
Great Lakes Gastroenterology Research - MentorMentorOhio44060-
North Shore GastroenterologyWestlakeOhio44145-
Options Health ResearchTulsaOklahoma74104-
University of Pittsburgh Medical CenterPittsburghPennsylvania15261-
Veterans Affairs Pittsburgh Healthcare System - University Drive CampusPittsburghPennsylvania15240-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Palmetto Clinical ResearchSummervilleSouth Carolina29485-
Clinovacare Medical Clinical Research CenterWest ColumbiaSouth Carolina29169-
Rapid City Medical CenterRapid CitySouth Dakota57701-
Gastro One - Germantown Office - Wolf Park DriveGermantownTennessee38138-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Texas Clinical Research InstituteArlingtonTexas76012-
Accelemed Research InstituteAustinTexas78745-
South Texas Research Institute - BrownsvilleBrownsvilleTexas78520-
Velocity Clinical Research - AustinCedar ParkTexas78613-
GI Alliance - Texas Digestive Disease Consultants - Fort Worth - DowntownDallasTexas75246-
Liver Center of TexasDallasTexas75234-
The Liver Institute at Methodist DallasDallasTexas75203-
Soma Clinical TrialsDenisonTexas75020-
South Texas Research Institute - EdinburgEdinburgTexas78539-
Care United Medical Center - ForneyForneyTexas75126-
Brooke Army Medical CenterFort Sam HoustonTexas78234-
Digestive Health Associates of Texas - RockwallGarlandTexas75044-
Houston Methodist HospitalHoustonTexas77030-
Houston Research Institute (HRI)HoustonTexas77079-
Liver Associates of TexasHoustonTexas77030-
Liver Specialists of TexasHoustonTexas77030-
Pioneer Research SolutionsHoustonTexas77099-
Summit - Pinnacle Clinical Research - AustinLive OakTexas78233-
GI Alliance - Lubbock Digestive Disease Associates - LubbockLubbockTexas79410-
GI Alliance - MansfieldMansfieldTexas76063-
Koncord Research - McAllen LLCMcAllenTexas78504-
Koncord Research-McAllen LLCMcAllenTexas78504-
Pinnacle Clinical Research - San AntonioSan AntonioTexas78229-
Quality Research - San AntonioSan AntonioTexas78209-
Sun Research InstituteSan AntonioTexas78215-
Texas Liver Institute/American Research CorporationSan AntonioTexas78215-
University of California San DiegoSan AntonioTexas78215-
Sherman Clinical ResearchShermanTexas75092-
Olympus Clinical ResearchSugar LandTexas77478-
Digestive Health Research of Central TexasWacoTexas76712-
Impact Research InstituteWacoTexas76710-
GI Alliance - Bay Area Gastroenterology - WebsterWebsterTexas77598-
Digestive Health Research of North TexasWichita FallsTexas76301-
Lone Peak Family HealthDraperUtah84020-
Physicians' Research Options LLC - Draper UT/Lone Peak Family ClinicDraperUtah84020-
University of Utah School of MedicineSalt Lake CityUtah84132-
University of Vermont Medical CenterBurlingtonVermont05401-
University of Virginia Health SystemCharlottesvilleVirginia22903-
Emeritas Research GroupLeesburgVirginia20176-
Topography Health, Inc.ManassasVirginia20110-
Bon Secours Liver Institute of Hampton RoadsNewport NewsVirginia23602-
Digestive & Liver Disease SpecialistsNorfolkVirginia23502-
GI Select Health Research, LLCRichmondVirginia23236-
Hunter Holmes Mcguire Veterans Affairs Medical Center - RichmondRichmondVirginia23249-
Virginia Commonwealth UniversityRichmondVirginia23284-
Liver Institute NorthwestSeattleWashington98105-
Froedtert and Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
Objective Health - Birmingham Gastroenterology Associates· Birmingham, ALDigestive Health Specialist of the Southeast· Dothan, ALNorth Alabama GI Research Center llc· Madison, ALThe Institute For Liver Health - Chandler· Chandler, AZArizona Liver Health - Peoria· Peoria, AZDignity Health - St. Joseph's Hospital and Medical Center· Phoenix, AZ

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