Clinical Trial Details

Trial ID: L0094
Source ID: NCT03166735
Associated Drug: BI 1467335
Title: Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT03166735/results
Conditions: Non-alcoholic Fatty Liver Disease
Interventions: Drug: BI 1467335|Drug: Placebo
Outcome Measures: Plasma Amine Oxidase Copper-containing 3 (AOC3) Activity After 12 Weeks of Treatment, Relative to Baseline in Percent|Percentage of Participants With Drug-related Adverse Events (AEs)|Alanine Aminotransaminase (ALT) After 12 Weeks of Treatment, Relative to Baseline in Percent|Aspartate Aminotransferase (AST) After 12 Weeks of Treatment, Relative to Baseline in Percent|Alkaline Phosphatase (AP) After 12 Weeks of Treatment, Relative to Baseline in Percent|Gamma-glutamyltransferase (GGT) After 12 Weeks of Treatment, Relative to Baseline in Percent|Caspase-cleaved Cytokeratin 18 (CK-18 Caspase) After 12 Weeks of Treatment, Relative to Baseline in Percent|Total Cytokeratin 18 (CK-18 Total) After 12 Weeks of Treatment, Relative to Baseline in Percent
Sponsor/Collaborators: Boehringer Ingelheim
Gender: All
Age: 18 Years to 75 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 114
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: June 6, 2017
Completion Date: June 14, 2019
Results First Posted: June 11, 2020
Last Update Posted: June 11, 2020
Locations: Southern California Research Center, Coronado, California, United States|University of California San Diego, La Jolla, California, United States|eStudySite, La Mesa, California, United States|National Research Institute, Los Angeles, California, United States|National Research Institute, Los Angeles, California, United States|Quest Clinical Research, San Francisco, California, United States|Florida Research Institute, Lakewood Ranch, Florida, United States|Genoma Research Group, Inc, Miami, Florida, United States|Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey, United States|Northwell Health, Manhasset, New York, United States|The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States|Duke University Medical Center, Durham, North Carolina, United States|Diabetes and Endocrinology Consultants, PC, Morehead City, North Carolina, United States|Dallas Diabetes and Endocrine Center, Dallas, Texas, United States|Pinnacle Clinical Research, Live Oak, Texas, United States|American Research Corporation at the Texas Liver Institute, San Antonio, Texas, United States|Virginia Commonwealth University, Richmond, Virginia, United States|Edegem - UNIV UZ Antwerpen, Edegem, Belgium|AZ Maria Middelares, Gent, Belgium|UZ Leuven, Leuven, Belgium|Centre Hospitalier Universitaire de Li??ge, Li??ge, Belgium|University of Calgary, Calgary, Alberta, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|HOP Claude Huriez, Lille, France|HOP La Piti?? Salp??tri??re, Paris, France|Universit??tsklinikum Aachen, A??R, Aachen, Germany|Universit??tsklinikum Frankfurt, Frankfurt am Main, Germany|Universit??tsklinikum K??ln (A??R), K??ln, Germany|Universit??tsklinikum Leipzig, Leipzig, Germany|Universit??tsmedizin der Johannes Gutenberg-Universit??t Mainz, Mainz, Germany|Universit??tsklinikum W??rzburg, W??rzburg, Germany|St James's Hospital, Dublin, Ireland|Amsterdam UMC, Locatie AMC, Amsterdam, Netherlands|Maastricht Universitair Medisch Centrum, Maastricht, Netherlands|Radboud Universitair Medisch Centrum, Nijmegen, Netherlands|Hospital Vall d'Hebron, Barcelona, Spain|Hospital Virgen de la Victoria, Malaga, Spain|Hospital Universitario Marqu??s de Valdecilla, Santander, Spain|Hospital Virgen del Roc??o, Sevilla, Spain|Hospital General Universitario de Valencia, Valencia, Spain|Queen Elizabeth Hospital, Birmingham, United Kingdom|Aintree University Hospital, Liverpool, United Kingdom|Manchester Royal Infirmary, Manchester, United Kingdom|Royal Stoke University Hospital, Stoke on Trent, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT03166735

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D036 BI 1467335 Chemical drug -- AOC3 activator -- Failed in clinical trials Details
D082 CK-18 Miscellany -- -- -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details
D545 Pig placenta extract Biological extract -- -- -- Under clinical trials Details