Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
NCT02548351 · REGENERATE Phase 3Terminated
- Lead sponsor
- Intercept Pharmaceuticals (Industry)
- Enrollment
- 2,477 (actual)
- Start date
- 22 Sep 2015
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023
- Last update posted
- 1 Oct 2024
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 3
Interventions
- Obeticholic Acid Drug
- Placebo Drug
Conditions and primary outcome
- Non Alcoholic Steatohepatitis (NASH)
Primary outcome
Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event (Up to 7 years)
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT02548351 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event
- Time frame
- Up to 7 years
- Measure
- Number
- Unit
- Percentage of participants
OCA 10 Milligrams (mg) vs PlaceboOther
- Estimate
- 0.814Hazard Ratio (HR)
- 95% CI, two-sided
- 0.635 to 1.043
- p-value
- 0.1028
- Method
- Log Rank
OCA 25 mg vs PlaceboOther
- Estimate
- 0.772Hazard Ratio (HR)
- 95% CI, two-sided
- 0.600 to 0.994
- p-value
- 0.0444
- Method
- Log Rank
Serious adverse events
Time frame: Up to 7 years
| Group | Affected | At risk |
|---|---|---|
| OCA 10 Milligrams (mg) | 273 | 825 |
| OCA 25 mg | 276 | 827 |
| Placebo | 248 | 825 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
5 on PubMedUtility of pathologist panels for achieving consensus in NASH histologic scoring in clinical trials: Data from a phase 3 study.
Hepatology communications · 2024 Jan 1
PubMed 38126958 (opens in a new tab)DOI 10.1097/HC9.0000000000000325 (opens in a new tab)
Obeticholic Acid Impact on Quality of Life in Patients With Nonalcoholic Steatohepatitis: REGENERATE 18-Month Interim Analysis.
Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022 Sep
PubMed 34274514 (opens in a new tab)DOI 10.1016/j.cgh.2021.07.020 (opens in a new tab)
Non-invasive evaluation of response to obeticholic acid in patients with NASH: Results from the REGENERATE study.
Journal of hepatology · 2022 Mar
PubMed 34793868 (opens in a new tab)DOI 10.1016/j.jhep.2021.10.029 (opens in a new tab)
Obeticholic acid for the treatment of non-alcoholic steatohepatitis: interim analysis from a multicentre, randomised, placebo-controlled phase 3 trial.
Lancet (London, England) · 2019 Dec 14
PubMed 31813633 (opens in a new tab)DOI 10.1016/S0140-6736(19)33041-7 (opens in a new tab)
REGENERATE: Design of a pivotal, randomised, phase 3 study evaluating the safety and efficacy of obeticholic acid in patients with fibrosis due to nonalcoholic steatohepatitis.
Contemporary clinical trials · 2019 Sep
PubMed 31260793 (opens in a new tab)DOI 10.1016/j.cct.2019.06.017 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT02548351 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.