Clinical Trial Details

Trial ID: L0285
Source ID: NCT02466516
Associated Drug: Simtuzumab
Title: Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Acronym: --
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT02466516/results
Conditions: Non-Alcoholic Steatohepatitis (NASH)
Interventions: Drug: SEL|Biological: SIM
Outcome Measures: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (SAEs), and Any Grade ??? 1 Laboratory Abnormality|Number of Participants Who Prematurely Discontinued Study Drug or Study Due to Adverse Events
Sponsor/Collaborators: Gilead Sciences
Gender: All
Age: 18 Years to 70 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 72
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
Start Date: June 8, 2015
Completion Date: October 11, 2016
Results First Posted: June 26, 2019
Last Update Posted: June 26, 2019
Locations: Stanford University Medical Center, Palo Alto, California, United States|University of California San Diego, San Diego, California, United States|University of California San Francisco, San Francisco, California, United States|University of Colorado Denver, Aurora, Colorado, United States|Northwestern University, Chicago, Illinois, United States|Indiana University School of Medicine, Indianapolis, Indiana, United States|Mercy Medical Center, Baltimore, Maryland, United States|Walter Reed National Military Medical Center, Bethesda, Maryland, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Duke University Medical Center, Durham, North Carolina, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States|University of Pittsburg Medical Center, Pittsburgh, Pennsylvania, United States|Texas Clinical Research Institute, Arlington, Texas, United States|Methodist Dallas Medical Center, Dallas, Texas, United States|CHI St. Luke's Health Baylor College of Medicine, Houston, Texas, United States|Brooke Army Medical Center Ft. Sam, Houston, Texas, United States|Digestive Research Center, Live Oak, Texas, United States|American Research Corporation at Texas Liver Institute, San Antonio, Texas, United States|Intermountain Medical Center, Murray, Utah, United States|University of Virginia, Charlottesville, Virginia, United States|Inova Fairfax Hospital, Falls Church, Virginia, United States|Mary Immaculate Hospital, Newport News, Virginia, United States|St. Mary's Hospital, Richmond, Virginia, United States|Virginia Commonwealth University Health System, Richmond, Virginia, United States|Swedish Medical Center, Seattle, Washington, United States|University of Calgary, Calgary, Alberta, Canada|Toronto Liver Centre, Toronto, Ontario, Canada
URL: https://ClinicalTrials.gov/show/NCT02466516

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D337 Simtuzumab Biological drug DB12152 LOXL2; antibody Anti-fibrosis; Anticancer agent; Immunomodulator; Failed in clinical trials Details
D326 Selonsertib Chemical drug DB14916 MAP3K5 inhibitor; ASK1 inhibitor Anti-oxidative stress; Anticancer agent Failed in clinical trials Details
D328 Serine Chemical drug DB00133 SRR Improve insulin resistance Under clinical trials Details