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NCT01694849 · ClinicalTrials.gov registry record · Phase 2
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Genfit.
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
NCT01694849: Completed Phase 2 study, sponsored by Genfit.
NCT01694849 is a Phase 2 study that has completed, run by Genfit. The registered enrollment target is 275 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01694849, a Phase 2 study, has completed, sponsored by Genfit.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as: * Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy * Progression to stage 4 for participants at stage 3 on di
Interventions
- DRUG Placebo
- DRUG GFT505 80mg
- DRUG GFT505 120mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-12 |
| Phase | Phase 2 |
What the finished NCT01694849 record still lists
NCT01694849 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01694849 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01694849 about?
NCT01694849 is a clinical study titled "Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)". 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...
What is the current status of trial NCT01694849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2012-09. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01694849?
The interventions under investigation include: Placebo (DRUG), GFT505 80mg (DRUG), GFT505 120mg (DRUG).
Who is sponsoring clinical trial NCT01694849?
This trial is sponsored by Genfit, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01694849's enrollment target sits among peer trials
275 203rd of 2000 higher than 1,798 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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