Comparison · NCT02704403-e429d395
120 mg Elafibranor vs Placebo: Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
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 Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis. Trial comparisons, record NCT02704403-e429d395. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02704403-e429d395
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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 | 0.192 | 0.165 | 0.223 | wilson | |
| Risk in group 2 | 0.147 | 0.114 | 0.188 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0452 | -0.00384 | 0.0902 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.975 | 1.75 | log | |
| Odds ratio, group 1 over group 2 | 1.38 | 0.974 | 1.95 | log | |
| Number needed to treat, for one more participant with the outcome on 120 mg Elafibranor than on Placebo | 22.1 | 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 | 138 | 717 | OG000 |
| Group 2 | Placebo | Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water | 52 | 353 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
- Description
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.
- Time frame
- Measurement at 72 weeks
- Population
- 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.
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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