Clinical Trial Details

Trial ID: L0243
Source ID: NCT01694849
Associated Drug: GFT505
Title: Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Acronym: --
Status: Completed
Study Results: No Results Available
Results: --
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Interventions: Drug: GFT505 80mg|Drug: GFT505 120mg|Drug: Placebo
Outcome Measures: Percentage of responders defined by the disappearance of steatohepatitis without worsening of fibrosis|Percentage of responders, defined by the disappearance of steatohepatitis|NAS score (Non-alcoholic fatty liver disease Activity Score)|Stages of steatosis, hepatic activity|Stages of fibrosis|Area of fibrosis|Liver enzymes|Non-invasive markers of fibrosis and steatosis|Lipid parameters|Body weight|Insulin resistance|Inflammatory markers|Safety markers|Cardiovascular risk profile
Sponsor/Collaborators: Genfit|Naturalpha|Premier Research Group plc
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 270
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: September 2012
Completion Date: December 2015
Results First Posted: --
Last Update Posted: January 14, 2016
Locations: Site 920, Fresno, California, United States|Site 903, La Jolla, California, United States|Site 911, Aurora, Colorado, United States|Site 912, Gainesville, Florida, United States|Site 924, Atlanta, Georgia, United States|Site 917, Atlanta, Georgia, United States|Site 909, New Orleans, Louisiana, United States|Site 921, Worcester, Massachusetts, United States|Site 902, Detroit, Michigan, United States|Site 927, New York, New York, United States|Site 908, Durham, North Carolina, United States|Site 919, Philadelphia, Pennsylvania, United States|Site 916, Memphis, Tennessee, United States|Site 913, Fort Sam Houston, Texas, United States|Site 923, Houston, Texas, United States|Site 906, San Antonio, Texas, United States|Site 931, Salt Lake City, Utah, United States|Site 930, Charlottesville, Virginia, United States|Site 901, Richmond, Virginia, United States|Site 205, Brussels, Belgium|Site 201, Edegem, Belgium|Site 204, Gent, Belgium|Site 202, Haine-Saint-Paul, Belgium|Site 203, Leuven, Belgium|Site 106, Amiens, France|Site 102, Angers, France|Site 114, Clichy, France|Site 103, Lille, France|Site 113, Lyon, France|Site 111, Marseille, France|Site 108, Montpellier, France|Site 104, Nantes, France|Site 109, Nice, France|Site 112, Paris, France|Site 101, Paris, France|Site 107, Pessac, France|Site 405, Bonn, Germany|Site 404, Mainz, Germany|Site 507, Milano, Italy|Site 503, Palermo, Italy|Site 504, Roma, Italy|Site 501, Torino, Italy|Site 303, Amsterdam, Netherlands|Site 302, Nijmegen, Netherlands|Site 603, Bucharest, Romania|Site 601, Bucharest, Romania|Site 602, Bucharest, Romania|Site 703, Barcelona, Spain|Site 707, Majadahonda, Spain|Site 705, Malaga, Spain|Site 706, Santander, Spain|Site 701, Sevilla, Spain|Site 802, Camberley, United Kingdom|Site 808, Hull, United Kingdom|Site 801, Newcastle Upon Tyne, United Kingdom|Site 803, Nottingham, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT01694849

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D478 GFT505 Chemical drug -- -- -- Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D545 Pig placenta extract Biological extract -- -- -- Under clinical trials Details