Clinical Trial Details

Trial ID: L0238
Source ID: NCT02855164
Associated Drug: Tropifexor
Title: Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH)
Acronym: FLIGHT-FXR
Status: Terminated
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT02855164/results
Conditions: Non-alcoholic Steatohepatitis (NASH)
Interventions: Drug: Tropifexor (LJN452)|Drug: Placebo
Outcome Measures: Number of Nonalcoholic Steatohepatitis (NASH) Patients With Treatment Emergent Adverse Events (TEAE)|Change in Transaminase Levels (ALT)|Change in Aspartate Transaminase (AST)|Change From Baseline in % of Fat in the Liver Assessed Using Magnetic Resonance Imaging (MRI)|Change From Baseline in Weight|Change in Body Mass Index (BMI)|Change From Baseline in Waist to Hip (WTH) Ratio|Change From Baseline in Biomarker FGF19|Change From Baseline in Biomarker C4|Change From Baseline on Markers of Liver Fibrosis, Fibroscan|Change From Baseline on Markers of Liver Fibrosis Panel (ELF) Score|Change From Baseline on Markers of Liver Fibrosis, Fibrotest (Parts A+B)|Change From Baseline on Markers of Liver Fibrosis, Fibrotest, (Part C)|Change From Baseline on Gamma-glutamyl Transferase (GGT)|Change From Baseline on Fasting Lipid Profile|Itch Based on a Visual Analog Scale (VAS) Rating Scale|Pre-dose Trough Concentration (Ctrough) of LJN452|C2h (Steady-state Drug Levels 2 Hours Postdose) of LJN452|Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening of Steatohepatitis (Part C) - Total Score|Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - FDA|Biopsy-based Response at Week 48 Compared to Baseline: At Least One Point Improvement in Fibrosis (NASH CRN Staging) Without Worsening - EMA|Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (Diagnostic Category)|Biopsy-based Response at Week 48 Compared to Baseline: Difference Between Treatment Groups (Part C) - Resolution of Steatohepatitis (FDA, EMA)
Sponsor/Collaborators: Novartis Pharmaceuticals|Novartis
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 350
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
Start Date: August 1, 2016
Completion Date: April 6, 2020
Results First Posted: July 29, 2021
Last Update Posted: September 5, 2021
Locations: Novartis Investigative Site, Madison, Alabama, United States|Novartis Investigative Site, North Little Rock, Arkansas, United States|Novartis Investigative Site, Coronado, California, United States|Novartis Investigative Site, Los Angeles, California, United States|Novartis Investigative Site, Pasadena, California, United States|Novartis Investigative Site, Rialto, California, United States|Novartis Investigative Site, San Diego, California, United States|Novartis Investigative Site, San Francisco, California, United States|Novartis Investigative Site, Lonetree, Colorado, United States|Novartis Investigative Site, Boca Raton, Florida, United States|Novartis Investigative Site, Jacksonville, Florida, United States|Novartis Investigative Site, Lakewood Ranch, Florida, United States|Novartis Investigative Site, Miami, Florida, United States|Novartis Investigative Site, Orlando, Florida, United States|Novartis Investigative Site, Pensacola, Florida, United States|Novartis Investigative Site, Athens, Georgia, United States|Novartis Investigative Site, Marietta, Georgia, United States|Novartis Investigative Site, Catonsville, Maryland, United States|Novartis Investigative Site, Worcester, Massachusetts, United States|Novartis Investigative Site, Detroit, Michigan, United States|Novartis Investigative Site, Minneapolis, Minnesota, United States|Novartis Investigative Site, Jefferson City, Missouri, United States|Novartis Investigative Site, Berlin, New Jersey, United States|Novartis Investigative Site, Morehead City, North Carolina, United States|Novartis Investigative Site, Cincinnati, Ohio, United States|Novartis Investigative Site, Hermitage, Tennessee, United States|Novartis Investigative Site, Dallas, Texas, United States|Novartis Investigative Site, Houston, Texas, United States|Novartis Investigative Site, San Antonio, Texas, United States|Novartis Investigative Site, Norfolk, Virginia, United States|Novartis Investigative Site, Richmond, Virginia, United States|Novartis Investigative Site, Caba, Buenos Aires, Argentina|Novartis Investigative Site, Caba, Buenos Aires, Argentina|Novartis Investigative Site, Buenos Aires, Argentina|Novartis Investigative Site, Kingswood, New South Wales, Australia|Novartis Investigative Site, Fitzroy, Victoria, Australia|Novartis Investigative Site, Salzburg, Austria|Novartis Investigative Site, Wien, Austria|Novartis Investigative Site, Bruxelles, Belgium|Novartis Investigative Site, Gent, Belgium|Novartis Investigative Site, Leuven, Belgium|Novartis Investigative Site, London, Ontario, Canada|Novartis Investigative Site, Toronto, Ontario, Canada|Novartis Investigative Site, Chicoutimi, Quebec, Canada|Novartis Investigative Site, Montpellier, France|Novartis Investigative Site, Paris, France|Novartis Investigative Site, Paris, France|Novartis Investigative Site, Dresden, Germany|Novartis Investigative Site, Hamburg, Germany|Novartis Investigative Site, Hannover, Germany|Novartis Investigative Site, Leipzig, Germany|Novartis Investigative Site, Wuerzburg, Germany|Novartis Investigative Site, New Delhi, Delhi, India|Novartis Investigative Site, Bergamo, BG, Italy|Novartis Investigative Site, Bologna, Italy|Novartis Investigative Site, Roma, Italy|Novartis Investigative Site, Hatsukaichi city, Hiroshima, Japan|Novartis Investigative Site, Yokohama-city, Kanagawa, Japan|Novartis Investigative Site, Saga-city, Saga, Japan|Novartis Investigative Site, Izumo-city, Shimane, Japan|Novartis Investigative Site, Seoul, Korea, Korea, Republic of|Novartis Investigative Site, Seoul, Korea, Korea, Republic of|Novartis Investigative Site, Dongjak Gu, Seoul, Korea, Republic of|Novartis Investigative Site, Busan, Korea, Republic of|Novartis Investigative Site, Seoul, Korea, Republic of|Novartis Investigative Site, Utrecht, Netherlands|Novartis Investigative Site, Singapore, Singapore|Novartis Investigative Site, Banska Bystrica, Slovakia|Novartis Investigative Site, Bratislava, Slovakia|Novartis Investigative Site, Bratislava, Slovakia|Novartis Investigative Site, Nitra, Slovakia|Novartis Investigative Site, Sevilla, Andalucia, Spain|Novartis Investigative Site, Barcelona, Cataluna, Spain|Novartis Investigative Site, Barcelona, Cataluna, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Madrid, Spain|Novartis Investigative Site, Kaoshiung, Taiwan|Novartis Investigative Site, Keelung City, Taiwan|Novartis Investigative Site, Taichung, Taiwan|Novartis Investigative Site, Taipei, Taiwan|Novartis Investigative Site, Taoyuan, Taiwan
URL: https://ClinicalTrials.gov/show/NCT02855164

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D379 Tropifexor Chemical drug DB16343 FXR agonist Enhance lipid metabolism Under clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details