Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03439254 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
A Phase 3 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 919
- Enrollment target
NCT03439254: Completed Phase 3 study, sponsored by Intercept Pharmaceuticals.
NCT03439254 is a Phase 3 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 919 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03439254, a Phase 3 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 919 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Primary Outcome
Fibrosis stage was evaluated by NASH Clinical Research Network(CRN)Fibrosis Staging System with stages:0=no fibrosis;1=perisinusoidal/periportal;1A=mild,zone 3,perisinusoidal;1B=moderate,zone 3,perisinusoidal;1C=portal/periportal;2=perisinusoidal and portal/periportal;3=bridging fibrosis;4=cirrhosis.No worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade as per scoring in relevant nonalcoholic fatty liver disease activity score (NAS)
Interventions
- DRUG Placebo
- DRUG Obeticholic acid (10 mg)
- DRUG Obeticholic acid (10 mg to 25 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 919 participants |
| Start Date | 2017-08-30 |
| Est. Completion | 2022-09-08 |
| Phase | Phase 3 |
What the finished NCT03439254 record still lists
NCT03439254 is an interventional study that assigns participants to a tested intervention. The registered 919 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03439254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03439254 about?
NCT03439254 is a clinical study titled "Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis". The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
What is the current status of trial NCT03439254?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 919 participants. The study started on 2017-08-30. Estimated completion is 2022-09-08.
What interventions are being tested in trial NCT03439254?
The interventions under investigation include: Placebo (DRUG), Obeticholic acid (10 mg) (DRUG), Obeticholic acid (10 mg to 25 mg) (DRUG).
Who is sponsoring clinical trial NCT03439254?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03439254's enrollment target sits among peer trials
919 347th of 2000 higher than 1,654 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04589845 · 920 participants · Phase 2
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
- NCT06109870 · 920 participants · NA
Prevención en Sus Manos: Feasibility of a Novel Community-Based Strategy to Improve Access to Cervical Cancer Screening
- NCT06957366 · 920 participants · NA
Perioperative Anticoagulant Use for Surgery Evaluation -2 (PAUSE-2) Study Patients Receiving a Direct Oral Anticoagulant (DOACs-Dabigatran, Rivaroxaban, Apixaban or Edoxaban) and Needing Elective High-Bleed-Risk Surgery or an Invasive Procedure
- NCT07174336 · 920 participants · Phase 3
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI