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Farnesoid X receptor (FXR) agonist

Obeticholic Acid for Non-alcoholic Fatty Liver Disease (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 end of study, estimated to be 7 years
Awards & highlights

REGENERATE Trial Summary

This trial is testing a new drug to see if it can improve the liver health of patients with NASH who have liver fibrosis.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

REGENERATE Trial Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Liver
Fibrosis
Secondary outcome measures
To evaluate the effect of Obeticholic Acid compared to placebo on liver biochemistry and markers of liver function
To evaluate the effect of Obeticholic Acid compared to placebo on liver histology in NASH

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

REGENERATE 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
27 Previous Clinical Trials
14,370 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
1,453 Patients Enrolled for Non-alcoholic Fatty Liver Disease
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
1 Trials studying Non-alcoholic Fatty Liver Disease
919 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Obeticholic Acid (Farnesoid X receptor (FXR) agonist) Clinical Trial Eligibility Overview. Trial Name: NCT02548351 — Phase 3
Non-alcoholic Fatty Liver Disease Research Study Groups: 25 mg Obeticholic Acid, 10 mg Obeticholic Acid, Placebo
Non-alcoholic 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can you tell me how many different research facilities are participating in this project?

"100 locations, including the Liver Wellness Center in Little Rock, UF Hepatology Research at CTRB in Gainesville, and Mayo Clinic in Rochester are participating."

Answered by AI

Could you please list other studies that have included Obeticholic Acid?

"As it stands, there are 7 ongoing studies that involve Obeticholic Acid. Out of these clinical trials, 2 are still in Phase 3. The majority of research regarding Obeticholic Acid takes place in Changchun, Jilin; however, there are a total of 424 research sites for this medication."

Answered by AI

Can new patients sign up for this research project?

"This particular trial is no longer accepting patients. The study was first announced on September 22nd, 2015 and the most recent update was November 1st, 2022. There are currently 244 other trials recruiting participants with non alcoholic steatohepatitis (nash) and 7 for Obeticholic Acid if you are interested in participating in a clinical trial."

Answered by AI

How many participants are allowed in this research project?

"Unfortunately, this study is not currently searching for patients. According to the clinical trial's website, it was initially posted on September 22nd, 2015 and updated November 1st, 2020. There are presently 244 studies actively enrolling patients with non alcoholic steatohepatitis (nash) and 7 trials for Obeticholic Acid actively recruiting participants."

Answered by AI

Can people of any age participate in this research?

"This study is taking in individuals that are above the age of 18 and younger than 85."

Answered by AI

Obeticholic Acid has been used to treat what medical conditions?

"Obeticholic Acid has been studied in multiple Phase 3 clinical trials, meaning that there is some data supporting its efficacy and safety. Our team at Power estimates the safety of Obeticholic Acid to be a 3 on a scale from 1 to 3."

Answered by AI

How can I sign up to be a subject in this clinical trial?

"The inclusion criteria for this clinical trial requires that patients have non alcoholic steatohepatitis (nash) and are between 18-85 years old. A total of 2480 participants will be accepted into the study."

Answered by AI

Does this medical experiment explore new territory?

"Intercept Pharmaceuticals first sponsored a study for Obeticholic Acid in 2015, which then led to the drug receiving Phase 3 approval that same year. Since then, there have been 7 active clinical trials involving the medication across 142 cities and 31 countries."

Answered by AI

Who else is applying?

What state do they live in?
California
Texas
New York
Other
How old are they?
18 - 65
What site did they apply to?
National Research Institute, Wilshire
Stanford University
Bruce W. Carter Miami VA Medical Center
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

finding a treatment, I volunteer for a tripl a couple of years ago, and after the Blood work, I was diagnoses with Fatty Liver. I sent the results to my primary doctor, but that is as far as it went.
PatientReceived 2+ prior treatments
Recent research and studies
~259 spots leftby Apr 2025