Clinical Trial Details

Trial ID: L0193
Source ID: NCT02787304
Associated Drug: Volixibat
Title: Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
Acronym: --
Status: Terminated
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT02787304/results
Conditions: Non-Alcoholic Steatohepatitis
Interventions: Drug: SHP626|Drug: Placebo
Outcome Measures: Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48|Change From Baseline to Week 48 on Liver Histology|Change From Baseline to Week 48 on Hepatic Steatosis|Number of Participants With Resolution of NASH at Week 48|Change From Baseline to Week 48 on Serum Liver-related Biochemistry|Change From Baseline to Week 48 on Metabolic Indicators|Change From Baseline to Week 48 on Serum Lipids
Sponsor/Collaborators: Mirum Pharmaceuticals, Inc.
Gender: All
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 197
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Double (Participant, Investigator)|Primary Purpose: Treatment
Start Date: October 24, 2016
Completion Date: July 27, 2018
Results First Posted: November 25, 2019
Last Update Posted: November 25, 2019
Locations: Southern California Research Center, Coronado, California, United States|Fresno Clinical Research Center, Fresno, California, United States|Ceders-Sinai Medical Center, Los Angeles, California, United States|California Liver Research Institute, Pasadena, California, United States|Inland Empire Liver Foundation, Rialto, California, United States|South Denver Gastroenterology, PC, Englewood, Colorado, United States|Medstar Georgetown University Hospital, Washington, District of Columbia, United States|George Washington (GW) Medical Faculty Associates, Washington, District of Columbia, United States|Schiff Center for Liver Diseases, Miami, Florida, United States|South Florida Center of Gastroenterology, Wellington, Florida, United States|Internal Medicine Associates of Wellstar Atlanta Medical, Atlanta, Georgia, United States|Emory University, Atlanta, Georgia, United States|Gastrointestinal Specialists of Georgia, Marietta, Georgia, United States|The Queen's Medical Center - Liver Center, Honolulu, Hawaii, United States|University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States|Liver Research Center, Louisville, Kentucky, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, United States|Louisiana Research Center, LLC, Shreveport, Louisiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Digestive Disease Associates, Catonsville, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|University of Massachusetts Medical School, Worcester, Massachusetts, United States|Henry Ford Health System, Novi, Michigan, United States|University of Mississippi Medical Center, Jackson, Mississippi, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States|Northwell Health Inc., Manhasset, New York, United States|Concorde Medical Group PLLC, New York, New York, United States|University of Rochester Medical Center, Rochester, New York, United States|Center for Liver Disease, Charlotte, North Carolina, United States|DUMC-Gastroenterology, Durham, North Carolina, United States|Cumberland Research Associates, LLC, Fayetteville, North Carolina, United States|Carolinas Center for Liver Disease, Statesville, North Carolina, United States|University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States|Medical University of South Carolina, Charleston, South Carolina, United States|Clinsearch, LLC, Chattanooga, Tennessee, United States|University of TN Health Science Center, Memphis, Tennessee, United States|Quality Medical Research, Nashville, Tennessee, United States|Austin Center for Clinical Research, Austin, Texas, United States|Methodist Health Systems Clinical, Dallas, Texas, United States|Baylor College of Medicine - Advanced Liver Therapies, Houston, Texas, United States|Texas Children's Hospital, Houston, Texas, United States|DHAT Research Institute, Richardson, Texas, United States|UVM Medical Center, Burlington, Vermont, United States|Digestive and Liver Disease Specialists, Norfolk, Virginia, United States|Bon Secours Liver Institute of Virginia, Richmond, Virginia, United States|McGuire VA Medical Center, Richmond, Virginia, United States|Virginia Mason Medical Center, Seattle, Washington, United States|UW Digestive Health Center (DHC), Madison, Wisconsin, United States|University of Calgary Liver Unit, Calgary, Alberta, Canada|LAIR Centre, Vancouver, British Columbia, Canada|Vancouver ID Research and Care Centre Society, Vancouver, British Columbia, Canada|Nova Scotia Heath Authority, Halifax, Nova Scotia, Canada|Toronto Liver Centre, Toronto, Ontario, Canada|CRCHUM, Montreal, Quebec, Canada|UPR: Medical Sciences Campus, San Juan, Puerto Rico|Royal Free Hospital, Hampstead, London, United Kingdom|Norfolk & Norwich University Hospital, Norwich, Norfolk, United Kingdom|John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom|NHS Tayside, Dundee, Tayside, United Kingdom|University Hospital Birmingham, Birmingham, West Midlands, United Kingdom|Royal London Hospital, London, United Kingdom|Nottingham Digestive Diseases Centre and Biomedical Research Unit, Nottingham, United Kingdom|Abertawe Bro Morgannwg University, Swansea, United Kingdom|York Clinical Research Facility, York, United Kingdom
URL: https://ClinicalTrials.gov/show/NCT02787304

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D332 Volixibat Chemical drug DB13914 SLC10A2 inhibitor; ASBT inhibitor Lipid regulating agents Failed in clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details