Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Public ClinicalTrials.gov record NCT01694849. 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 Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 Once Daily on Steatohepatitis in Patients With Non-Alcoholic Steatohepatitis (NASH).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver cancer. NAFLD (Non Alcoholic Fatty Liver Disease) is considered as the most common form of chronic liver disease in adults in the United States, Australia, Asia and Europe. In the USA, the estimated prevalence of NAFLD is 20-30% of the adult population. Non-alcoholic Steatohepatitis (NASH) is a progressing form of NAFLD, which corresponds to hepatic steatosis associated with inflammation and liver cell injury upon microscopic examination of a liver biopsy. This condition may lead to advanced fibrosis and cirrhosis and deserves serious medical management. Up to now, there is no effective drug which has clearly demonstrated therapeutic efficacy which may help lifestyle and dietary recommendations in the resolution of NASH. In this context, GENFIT is developing a new liver targeted drug candidate, GFT505, for the treatment of NASH and the reduction of multiple cardiometabolic risk factors associated with the metabolic syndrome and type 2 Diabetes. This phase IIb study will evaluate the efficacy and safety of GFT505 80mg and 120mg once daily for 52 weeks on the reversal of NASH without worsening of fibrosis, based on liver biopsy assessments.
Study identification
- NCT ID
- NCT01694849
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 275 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 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
- Aug 31, 2012
- Primary completion
- Jan 31, 2015
- Completion
- Nov 30, 2015
- Last update posted
- Nov 2, 2022
2012 – 2015
United States locations
- U.S. sites
- 19
- U.S. states
- 14
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Site 920 | Fresno | California | CA 9372 | — |
| Site 903 | La Jolla | California | CA 92037 | — |
| Site 911 | Aurora | Colorado | CO 80045 | — |
| Site 912 | Gainesville | Florida | FL 32610-0277 | — |
| Site 924 | Atlanta | Georgia | GA 30303 | — |
| Site 917 | Atlanta | Georgia | GA 30322 | — |
| Site 909 | New Orleans | Louisiana | LA 70112-2600 | — |
| Site 921 | Worcester | Massachusetts | MA 01655 | — |
| Site 902 | Detroit | Michigan | MI 48202 | — |
| Site 927 | New York | New York | NY 10029-6574 | — |
| Site 908 | Durham | North Carolina | NC 27710 | — |
| Site 919 | Philadelphia | Pennsylvania | PA 19104 | — |
| Site 916 | Memphis | Tennessee | TN 38104 | — |
| Site 913 | Fort Sam Houston | Texas | TX 78234 | — |
| Site 923 | Houston | Texas | TX 77030 | — |
| Site 906 | San Antonio | Texas | TX 78215 | — |
| Site 931 | Salt Lake City | Utah | UT 84132 | — |
| Site 930 | Charlottesville | Virginia | VA 22908 | — |
| Site 901 | Richmond | Virginia | VA 23298 | — |
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 37 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01694849, 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 Nov 2, 2022 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01694849 live on ClinicalTrials.gov.