Comparison · NCT02704403-288e170a
120 mg Elafibranor vs Placebo: Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 120 mg Elafibranor vs Placebo: Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage. Trial comparisons, record NCT02704403-288e170a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02704403-288e170a
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.245 | 0.215 | 0.278 | wilson | |
| Risk in group 2 | 0.224 | 0.183 | 0.27 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0217 | -0.0336 | 0.0737 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.1 | 0.869 | 1.38 | log | |
| Odds ratio, group 1 over group 2 | 1.13 | 0.834 | 1.53 | log | |
| Number needed to treat, for one more participant with the outcome on 120 mg Elafibranor than on Placebo | 46.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 120 mg Elafibranor | Coated 120 mg elafibranor tablets; oral administration; one tablet per day before breakfast with a glass of water | 176 | 717 | OG000 |
| Group 2 | Placebo | Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water | 79 | 353 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage
- Description
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.
- Time frame
- Measurements at 72 weeks
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT02704403
- Phases
- PHASE3
- Conditions
- Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- Interventions
- Elafibranor, Placebo
- Lead sponsor
- Genfit
- Results first posted
- 2022-03-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02704403?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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