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Farnesoid X receptor (FXR) agonist

Obeticholic acid (10 mg to 25 mg) for Liver Disease (REVERSE 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
1. Subjects with a confirmed diagnosis of NASH and a fibrosis score of 4 based upon the NASH CRN scoring system determined by central reading
Key
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

REVERSE Trial Summary

This trial will test whether obeticholic acid can improve liver fibrosis without worsening NASH in people with compensated cirrhosis.

Eligible Conditions
  • Liver Disease
  • Non-alcoholic Fatty Liver Disease

REVERSE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

REVERSE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
DB Phase: Number of Participants Who Were Responders and Showed Improvement in Fibrosis by at Least 1 Stage Without Worsening of Nonalcoholic Steatohepatitis (NASH)
OLE Phase: Change From Baseline to Month 12 in Liver Stiffness Measurement (LSM)
OLE Phase: Enhanced Liver Fibrosis (ELF) at Baseline
+6 more
Secondary outcome measures
DB Phase: Change From Baseline to Month 18 in LSM
DB Phase: ELF at Baseline
DB Phase: FIB-4 at Baseline

Side effects data

From 2022 Phase 3 trial • 919 Patients • NCT03439254
57%
Pruritus
16%
Nausea
12%
Fatigue
11%
Low density lipoprotein increased
11%
Constipation
9%
Urinary tract infection
9%
Rash
9%
Arthralgia
8%
Vomiting
8%
Abdominal pain
7%
Hyperlipidaemia
7%
Varices oesophageal
7%
Diabetes mellitus
7%
Diarrhoea
7%
Abdominal distension
7%
Abdominal pain upper
6%
Blood bilirubin increased
6%
Upper respiratory tract infection
6%
Cough
6%
Headache
6%
Back pain
6%
Sinusitis
5%
Nasopharyngitis
5%
Dizziness
5%
Muscle spasms
4%
Dyspnoea
4%
Blood creatinine increased
3%
Bronchitis
3%
Insomnia
2%
Pain in extremity
1%
Cerebrovascular accident
1%
COVID-19 pneumonia
1%
Procedural pain
1%
Diabetes mellitus inadequate control
100%
80%
60%
40%
20%
0%
Study treatment Arm
DB: Placebo
DB: OCA 10 mg Titrated to OCA 25 mg
OLE: OCA 10 mg (DB Placebo)
OLE: OCA 10 mg (DB OCA 10 mg)
DB: OCA 10 Milligrams (mg)
OLE: Titrated to OCA 25 mg (DB OCA 10 mg Titrated to OCA 25 mg)

REVERSE Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Obeticholic Acid (OCA) 10 mg to 25 mgExperimental Treatment1 Intervention
10 mg OCA for the first 3 months and then may titrate up to 25 mg OCA for the remaining 15 months of the study
Group II: Obeticholic Acid (OCA) 10 mgExperimental Treatment1 Intervention
10 mg OCA for up to 18 months
Group III: PlaceboPlacebo Group1 Intervention
Placebo for up to 18 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obeticholic acid (10 mg)
2017
Completed Phase 3
~920
Obeticholic acid (10 mg to 25 mg)
2017
Completed Phase 3
~920

Find a Location

Who is running the clinical trial?

Intercept PharmaceuticalsLead Sponsor
27 Previous Clinical Trials
15,931 Total Patients Enrolled
Steven Shiff, MDStudy DirectorIntercept Pharmaceuticals
2 Previous Clinical Trials
2,967 Total Patients Enrolled

Frequently Asked Questions

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

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
65+
What site did they apply to?
Duke University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
2017. "Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03439254.
~121 spots leftby Apr 2025
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