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
Completed · Phase 2
Conditions studied: Non-Alcoholic Steatohepatitis (NASH)
In brief
The primary objective of this study is to evaluate the safety and tolerability of GS-4997 (selonsertib \[SEL\]) alone or in combination with simtuzumab (SIM) in adults with nonalcoholic steatohepatitis (NASH) and fibrosis stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.
Key facts
- Study ID
- NCT02466516
- Run by
- Gilead Sciences
- People needed
- 72
- Starts
- 2015-06-08
- Expected to finish
- 2016-10-11
- Last updated by the study team
- 2019-06-26
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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