Comparison · NCT01265498-54526ece
Obeticholic Acid vs Placebo: Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Obeticholic Acid vs Placebo: Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS). Trial comparisons, record NCT01265498-54526ece. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01265498-54526ece
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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 | 0.455 | 0.365 | 0.548 | wilson | |
| Risk in group 2 | 0.211 | 0.145 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | 0.244 | 0.119 | 0.358 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.15 | 1.42 | 3.27 | log | |
| Odds ratio, group 1 over group 2 | 3.12 | 1.72 | 5.64 | log | |
| Number needed to treat, for one more participant with the outcome on Obeticholic Acid than on Placebo | 4.11 | 2.8 | 8.39 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Obeticholic Acid | obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks | 50 | 110 | OG000 |
| Group 2 | Placebo | Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks | 23 | 109 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
- Description
Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:~1. No worsening in fibrosis; and~2. A decrease in NAFLD Activity Score (NAS) of at least 2 points
- Time frame
- baseline to 72 weeks
- Population
Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement.
Source ClinicalTrials.gov
Trial
- Title
- The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
- NCT number
- NCT01265498
- Phases
- PHASE2
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
- Interventions
- obeticholic acid, placebo
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Results first posted
- 2015-08-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01265498?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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