Trial · NCT01694849
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT01694849, Phase 2, Completed, Genfit; results first posted 2022-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH). Trials, record NCT01694849. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01694849
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
- NCT number
- NCT01694849
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 275 participants, actual
- Lead sponsor
- Genfit
- Conditions
- Non-Alcoholic Steatohepatitis (NASH)
- Interventions
- GFT505 80mg, GFT505 120mg, Placebo
- First posted
- 2012-09-27
- Last updated
- 2022-11-03
- Other registries' IDs
- eudract:2012-000295-42
- Results first posted
- 2022-11-03
Source ClinicalTrials.gov
Registered outcomes48
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | 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 diagnostic liver biopsy |
| Secondary | Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score). NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. |
| Secondary | Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis. In table below for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10). |
| Secondary | Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52. Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (\<5%), while a score of 3 is indicative of higher involvment/severity (\> 66%). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10). |
| Secondary | Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52. Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field. In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10). |
| Secondary | Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52. Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few \[rare but definite\] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10). |
| Secondary | Changes From Baseline to Week 52 in the Stages of Fibrosis | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network \[NASH CRN\] scoring). Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. |
| Secondary | Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes. |
| Secondary | Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio |
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis). |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 registered outcomesOutcomes48
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Analysis was done of the efficacy evaluable sample, (Efficacy Evaluable Set) formed by participants with liver biopsy available at end-of-treatment and considered as the Intent to Treat population in the protocol. Robustness analysis was also performed in the Full Analysis Set, formed by all randomized participants that received at least one dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | NAS score | MEAN |
| SECONDARY | Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Changes From Baseline to Week 52 in the Stages of Fibrosis | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | Change in fibrosis score | MEAN |
| SECONDARY | Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | U/L | MEAN |
| SECONDARY | Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | ratio | MEAN |
| SECONDARY | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65 | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | Efficacy evaluable set | U/L | MEAN |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 outcomesResults by group258
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 80mg | Efficacy evaluable set / Responders | 21 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 120mg | Efficacy evaluable set / Responders | 19 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Placebo | Efficacy evaluable set / Responders | 16 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 80mg | Efficacy evaluable set / Non-responders | 61 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 120mg | Efficacy evaluable set / Non-responders | 59 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Placebo | Efficacy evaluable set / Non-responders | 61 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 80mg | Full analysis set / Responders | 21 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 120mg | Full analysis set / Responders | 19 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Placebo | Full analysis set / Responders | 16 | Participants | |
| Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | GFT505 80mg | Full analysis set / Non-responders | 72 | Participants |
1 to 10 of 258Source ClinicalTrials.gov
See all 258 results by groupParticipant flow27
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period (Visit 2 to Visit 8) | STARTED | GFT505 80mg | 93 | |
| Treatment Period (Visit 2 to Visit 8) | STARTED | GFT505 120mg | 90 | |
| Treatment Period (Visit 2 to Visit 8) | STARTED | Placebo | 92 | |
| Treatment Period (Visit 2 to Visit 8) | Randomized | GFT505 80mg | 93 | |
| Treatment Period (Visit 2 to Visit 8) | Randomized | GFT505 120mg | 90 | |
| Treatment Period (Visit 2 to Visit 8) | Randomized | Placebo | 92 | |
| Treatment Period (Visit 2 to Visit 8) | Randomised and Received Treatment (Full Analysis Set and Safety Set) | GFT505 80mg | 93 | |
| Treatment Period (Visit 2 to Visit 8) | Randomised and Received Treatment (Full Analysis Set and Safety Set) | GFT505 120mg | 89 | |
| Treatment Period (Visit 2 to Visit 8) | Randomised and Received Treatment (Full Analysis Set and Safety Set) | Placebo | 92 | |
| Treatment Period (Visit 2 to Visit 8) | Efficacy Evaluable Set | GFT505 80mg | 82 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 participant flowAdverse events276
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | GFT505 80mg | 18 | 93 | 23 |
| other | Nausea | Gastrointestinal disorders | GFT505 120mg | 17 | 89 | 20 |
| other | Nausea | Gastrointestinal disorders | Placebo | 14 | 92 | 16 |
| other | Abdominal pain upper | Gastrointestinal disorders | GFT505 80mg | 12 | 93 | 14 |
| other | Abdominal pain upper | Gastrointestinal disorders | GFT505 120mg | 9 | 89 | 11 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 13 | 92 | 15 |
| other | Abdominal pain | Gastrointestinal disorders | GFT505 80mg | 9 | 93 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | GFT505 120mg | 11 | 89 | 12 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 11 | 92 | 12 |
| other | Diarrhoea | Gastrointestinal disorders | GFT505 80mg | 14 | 93 | 17 |
1 to 10 of 276Source ClinicalTrials.gov
See all 276 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GFT505 80mg | 0 | 93 |
| Total, all-cause mortality | GFT505 120mg | 0 | 89 |
| Total, all-cause mortality | Placebo | 0 | 92 |
| Total, other adverse events | GFT505 80mg | 85 | 93 |
| Total, other adverse events | GFT505 120mg | 86 | 89 |
| Total, other adverse events | Placebo | 85 | 92 |
| Total, serious adverse events | GFT505 80mg | 12 | 93 |
| Total, serious adverse events | GFT505 120mg | 14 | 89 |
| Total, serious adverse events | Placebo | 9 | 92 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26874076 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01694849
GET https://conductscience.org/api/trials/v1/NCT01694849/registered?page=2