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Farnesoid X receptor (FXR) agonist

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment (REGENERATE Trial)

Phase 3
Waitlist Available
Research Sponsored by Intercept Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing Obeticholic Acid to see if it can help improve liver health in patients with NASH, a type of liver disease that causes scarring but not cirrhosis. The medication works by reducing inflammation and scarring in the liver. However, it can cause side effects like itching and changes in cholesterol levels.

Eligible Conditions
  • Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to the First Adjudicated Event for Clinical Outcome Composite Endpoint: Percentage of Participants With an Event
Secondary study objectives
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Percentage of Participants Who Showed Improvement in Fibrosis by at Least 1 Stage and/or Resolution of NASH Without Worsening of Either Using Consensus Read Method
Percentage of Responders With Improvement of Fibrosis by at Least One Stage With no Worsening of NASH Using Consensus Read Method of Scheduled Liver Biopsies

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT02430077
40%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo for Obeticholic Acid
Active Capsule of Obeticholic Acid

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 25 mg Obeticholic AcidExperimental Treatment1 Intervention
25 mg Obeticholic Acid daily for the remainder of the study
Group II: 10 mg Obeticholic AcidExperimental Treatment1 Intervention
10 mg Obeticholic Acid daily for the remainder of the study
Group III: PlaceboPlacebo Group1 Intervention
One tablet daily for the remainder of the study
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obeticholic Acid
2015
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
28 Previous Clinical Trials
14,503 Total Patients Enrolled
Sangeeta Sawhney, MDStudy DirectorIntercept Pharmaceuticals
1 Previous Clinical Trials
1,405 Total Patients Enrolled
Steven Shiff, MDStudy DirectorIntercept Pharmaceuticals
2 Previous Clinical Trials
1,406 Total Patients Enrolled

Media Library

Obeticholic Acid (Farnesoid X receptor (FXR) agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02548351 — Phase 3
Fatty Liver Disease Research Study Groups: 25 mg Obeticholic Acid, 10 mg Obeticholic Acid, Placebo
Fatty Liver Disease Clinical Trial 2023: Obeticholic Acid Highlights & Side Effects. Trial Name: NCT02548351 — Phase 3
Obeticholic Acid (Farnesoid X receptor (FXR) agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02548351 — Phase 3
~244 spots leftby Dec 2025
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