Trial · NCT02704403
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02704403, Phase 3, Terminated, Genfit; results first posted 2022-03-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT02704403. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02704403
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT02704403
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,157 participants, actual
- Lead sponsor
- Genfit
- Conditions
- Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- Interventions
- Elafibranor, Placebo
- First posted
- 2016-03-10
- Last updated
- 2022-03-23
- Other registries' IDs
- eudract:2015-005385-38
- Results first posted
- 2022-03-23
- Limitations and caveats
The study was prematurely terminated based upon limited efficacy at time of the interim analysis, not due to safety concerns, and the conclusion that there would be limited benefit for participants to continue in the trial. Therefore, the results for efficacy endpoints other than the primary and key secondary endpoints are not presented in the disclosure of these results.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis | Measurement at 72 weeks | To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis. |
| Primary | Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) | Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis. |
| Secondary | Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage | Measurements at 72 weeks | To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
| Secondary | Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
| Secondary | Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
| Secondary | Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
| Secondary | Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants | Measurements after 72 weeks of treatment and up to study termination | Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
| Secondary | Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
| Secondary | Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis | Measurement at 72 weeks | Intent-to-treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant) | Full Intent-to-Treat Set: All randomized participants. Participants were analyzed according to their randomized treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage | Measurements at 72 weeks | Intent-to-Treat Set: For the purpose of analysis sets aligned with efficacy summaries, a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early were considered. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. Number of participants with diabetes who had available data at Week 72 are presented. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants | Measurements after 72 weeks of treatment and up to study termination | Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. | index | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo | Measurements after 72 weeks of treatment and up to study termination | Intent-to-Treat Set: a cohort of randomized F2 to F3 participants who completed the Week 72 treatment period or discontinued the study treatment early. | mmol/L | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis | 120 mg Elafibranor | 138 | Participants | ||
| Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis | Placebo | 52 | Participants | ||
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | 120 mg Elafibranor | Baseline / Events | 0 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | Placebo | Baseline / Events | 0 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | 120 mg Elafibranor | Baseline / Censored | 0 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | Placebo | Baseline / Censored | 0 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | 120 mg Elafibranor | Baseline / No events or not censored | 1437 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | Placebo | Baseline / No events or not censored | 720 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | 120 mg Elafibranor | 6 months / Events | 1 | Participants | |
| Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes | Placebo | 6 months / Events | 1 | Participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 120 mg Elafibranor | 1,437 | |
| Overall Study | STARTED | Placebo | 720 | |
| Overall Study | Full Intent-to-Treat Population | 120 mg Elafibranor | 1,437 | |
| Overall Study | Full Intent-to-Treat Population | Placebo | 720 | |
| Overall Study | Full Safety Population | 120 mg Elafibranor | 1,433 | |
| Overall Study | Full Safety Population | Placebo | 717 | |
| Overall Study | COMPLETED | 120 mg Elafibranor | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | 120 mg Elafibranor | 1,437 | |
| Overall Study | NOT COMPLETED | Placebo | 720 |
Source ClinicalTrials.gov
Adverse events596
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 | Diarrhoea | Gastrointestinal disorders | 120 mg Elafibranor | 148 | 1,433 | 171 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 68 | 717 | 82 |
| other | Nausea | Gastrointestinal disorders | 120 mg Elafibranor | 140 | 1,433 | 158 |
| other | Nausea | Gastrointestinal disorders | Placebo | 50 | 717 | 51 |
| other | Abdominal pain upper | Gastrointestinal disorders | 120 mg Elafibranor | 83 | 1,433 | 105 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 47 | 717 | 49 |
| other | Abdominal pain | Gastrointestinal disorders | 120 mg Elafibranor | 79 | 1,433 | 94 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 49 | 717 | 57 |
| other | Fatigue | General disorders | 120 mg Elafibranor | 103 | 1,433 | 111 |
| other | Fatigue | General disorders | Placebo | 49 | 717 | 54 |
1 to 10 of 596Source ClinicalTrials.gov
See all 596 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 120 mg Elafibranor | 6 | 1,437 |
| Total, all-cause mortality | Placebo | 3 | 720 |
| Total, other adverse events | 120 mg Elafibranor | 1,227 | 1,433 |
| Total, other adverse events | Placebo | 601 | 717 |
| Total, serious adverse events | 120 mg Elafibranor | 190 | 1,433 |
| Total, serious adverse events | Placebo | 95 | 717 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| 120 mg Elafibranor vs Placebo: Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage | Trial comparisons |
| 120 mg Elafibranor vs Placebo: deaths from any cause | Trial comparisons |
| 120 mg Elafibranor vs Placebo: Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis | Trial comparisons |
| 120 mg Elafibranor vs Placebo: serious adverse events | Trial comparisons |
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/NCT02704403
GET https://conductscience.org/api/trials/v1/NCT02704403/results?page=2