Clinical Trial Details

Trial ID: L0183
Source ID: NCT03008070
Associated Drug: IVA337
Title: Phase 2b Study in NASH to Assess IVA337
Acronym: NATIVE
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03008070/results
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Interventions: Drug: IVA337|Drug: Placebo
Outcome Measures: SAF Activity Score (SAF-A) Decrease of at Least 2 Points With no Worsening of the CRN Fibrosis Score (CRN-F)|NASH Improvement|NASH Resolution and no Worsening of Fibrosis|Improvement of Fibrosis by at Least 1 Stage and no Worsening of NASH|Activity (SAF-A) Improvement|Steatosis (CRN-S) Improvement|Lobular Inflammation (CRN-I) Improvement|Hepatocyte Balooning (CRN-B) Improvement|Fibrosis (CRN-F) Improvement|Modified ISHAK Fibrosis (ISHAK-F) Improvement|Absolute Change in ALT|Absolute Change in AST|Absolute Change in GGT|Absolute Change in Fibrinogen|Absolute Change in Hs-CRP|Absolute Change in Alpha2 Macroglobulin|Absolute Change in Haptoglobulin|Absolute Change of Fasting Plasma Glucose|Absolute Change in Insulin|Absolute Change in HOMA Index|Absolute Change in HbA1c|Absolute Change in Total Cholesterol|Absolute Change of HDL-Cholesterol|Absolute Change of LDL-Cholesterol|Absolute Change in Triglycerides|Absolute Change in Apo A1|Absolute Change in Adiponectin|Resolution of NASH and Improvement of Fibrosis by at Least 1 Stage
Sponsor/Collaborators: Inventiva Pharma
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 247
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: February 7, 2017
Completion Date: March 16, 2020
Results First Posted: April 12, 2021
Last Update Posted: April 12, 2021
Locations: North Alabama GI Research Center, Madison, Alabama, United States|ACTRI, La Jolla, California, United States|National Research Institute, Los Angeles, California, United States|Palmetto Research, LLC, Hialeah, Florida, United States|Florida Digestive Health Specialists, LLP, Lakewood Ranch, Florida, United States|Northeast GI Research Division, Concord, Massachusetts, United States|Duke University Medical Center, Durham, North Carolina, United States|Carolina's Center for Liver Disease/CHG, Huntersville, North Carolina, United States|Jefferson University hospital, Philadelphia, Pennsylvania, United States|Digestive Health Research, LLC, Hermitage, Tennessee, United States|The Texas Liver Institute, San Antonio, Texas, United States|Digestive Health Research, LLC, San Antonio, Texas, United States|University of Virginia Health System, Charlottesville, Virginia, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Flinders Medical Centre Department of Hepatology, Bedford Park, Australia|Monash Medical Centre, Clayton, Australia|Lyell McEwin Hospital & The University of Adelaide, Elizabeth Vale, Australia|Royal Brisbane and Women's Hospital, Herston, Australia|Fiona Stanley Hospital, Murdoch, Australia|Medical University Vienna, Vienna, Austria|Hopital Erasme, Brussels, Belgium|Clinique Universitaire Saint-luc, Brussels, Belgium|Antwerp University Hospital, Edegem, Belgium|Ziekenhuis Oost Limburg, Genk, Belgium|UZ Gent, Gent, Belgium|"DCC Alexandrovska", EOOD, Sofia, Bulgaria|Acibadem City Clinic Tokuda Hospital, Sofia, Bulgaria|Acibadem City Clinic University Hospital EOOD, Sofia, Bulgaria|MHAT "Sveta Anna" Sofia, Sofia, Bulgaria|Military Medical Academy - MHAT, Sofia, Bulgaria|UMHAT "Sv. Ivan Rilski", Sofia, Bulgaria|UMHAT "Tsaritsa Yoanna-ISUL", Sofia, Bulgaria|University of Calgary, Calgary, Canada|The Bailey Health Clinic, Edmonton, Canada|CISSS de la Mont??r??gie Centre, Greenfield Park, Canada|University of Western Ontario, London Health Sciences Centre, London, Canada|McGill University Health Centre (MUHC), Montr??al, Canada|Medpharmgene, Inc, Montr??al, Canada|LAIR Centre, Vancouver, Canada|Researchsite S.R.O., Plzen, Czechia|Klin Med S.R.O., Praha, Czechia|Institut klinick?? a experiment??ln?? medic??ny, IKEM, Praha, Czechia|CHU Angers, Angers, France|CHRU Besan??on, Besancon, France|Centre Hospitalier de Bordeaux, Bordeaux, France|CHU Henri Mondor, Cr??teil, France|CHU de Grenoble, Grenoble, France|H??pital de La Croix Rousse, Lyon, France|Centre Hospitalier R??gional Universitaire de Montpellier, Montpellier, France|CHU de Nice, Nice, France|H??pital Saint Antoine, Paris, France|H??pital La Piti?? Salp??tri??re, Paris, France|H??pital Beaujon, Paris, France|Centre Hospitalier Universitaire de Rennes, Rennes, France|H??pital de Hautepierre, Strasbourg, France|H??pital Purpan - Centre Hospitalier Universitaire (CHU) de Toulouse, Toulouse, France|RWTH University Hospital, Aachen, Germany|Innere Medizin II - Universit??tsklinik Freiburg, Freiburg, Germany|Medizinischen Klinik IV, Heidelberg, Germany|Universit??tsmedizin Mainz, I. Med. Klinik, Mainz, Germany|Universit??tsklinikum M??nster, M??nster, Germany|University Hospital W??rzburg, Wurzburg, Germany|Ospedali Riuniti di Ancona-Universit?? Politecnica delle Marche, Ancona, Italy|Granda Ospedale Maggiore Policlinico - Universit?? di Milano, Milano, Italy|Pol. Giaccone, Palermo, Italy|Fondazione Policlinico Agostino Gemelli, Roma, Italy|Poliambulatorio Giovanni Paolo II, San Giovanni Rotondo, Italy|A.O. Citt?? della Salute e della Scienza di Torino, Torino, Italy|CAP Research, Quatre Bornes, Mauritius|Oddzial Gastroenterologii Hepatologii UCK, Katowice, Poland|Katedra i Klinika Chor??b Zaka??nych i Hepatologii Uniwersytetu Medycznego w ??odzi, Lodz, Poland|Klinika Chor??b Zaka??nych, Lublin, Poland|Centrum Badan Klinicznych, Wroc??aw, Poland|General hospital Celje, Celje, Slovenia|General Hospital Murska Sobota, Murska Sobota, Slovenia|Vall d'Hebron Hospital, Barcelona, Spain|Hospital Puerta de Hierro MAJADAHONDA, Madrid, Spain|Virgen de la Victoria University Hospital, Malaga, Spain|Hospital Universitario Marqu??s de Valdecilla, Santander, Spain|Hospital Virgen del Roc??o, Sevilla, Spain|Universit??tsklinik f??r Viszerale Chirurgie und Medizin, Bern, Switzerland|Epatocentro Ticino, Lugano, Switzerland|Kings College Hospital NHS Foundation Trust, London, United Kingdom|Freeman Hospital, Newcastle University, Newcastle, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT03008070

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D200 Lanifibranor Chemical drug DB14801 PPARD agonist; PPARA agonist; PPARG agonist Dermatological drug Advanced in clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details