Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Public ClinicalTrials.gov record NCT01672866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like Molecule 2 (LOXL2), in Subjects With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase * Open-Label Phase (optional)
Study identification
- NCT ID
- NCT01672866
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 5, 2012 (Actual)
- Primary completion
- Aug 2, 2016 (Actual)
- Completion
- Dec 29, 2016 (Actual)
- Last update posted
- Mar 27, 2019
2012 – 2016
United States locations
- U.S. sites
- 41
- U.S. states
- 25
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Southern California Liver Centers | Coronado | California | 92118 | — |
| University of California, San Diego (UCSD) | San Diego | California | 92103 | — |
| University of California San Francisco (UCSF) | San Francisco | California | 94143 | — |
| University of Colorado | Aurora | Colorado | 80045 | — |
| Miami Veterans Administration Healthcare System | Miami | Florida | 33136 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | — |
| Iowa Digestive Disease Center | Clive | Iowa | 50325 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tulane University | New Orleans | Louisiana | 70112 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Lahey Clinic | Burlington | Massachusetts | 01805 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Minnnesota Gastroenterology, PA | Saint Paul | Minnesota | 55114 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Saint Louis University Hospital | St Louis | Missouri | 63110 | — |
| State University Of New York | Buffalo | New York | 14203 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Mount Sinai Hospital | New York | New York | 10029 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University Gastroenterology | Providence | Rhode Island | 02905 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| St. Luke's Episcopal Hospital | Houston | Texas | 77030 | — |
| Alamo Clinical Research Associates | San Antonio | Texas | 78215 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | — |
| Liver Institute of Virginia | Newport News | Virginia | 23602 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Bucheon St. Marys Hospital | Richmond | Virginia | 23229 | — |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Washington | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01672866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 27, 2019 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01672866 live on ClinicalTrials.gov.