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Farnesoid X receptor agonist

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

Phase 2
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 baseline, week 4, week 8/end of treatment (eot), week 12, month 6, month 12, month 18, month 24/eot
Awards & highlights
No Placebo-Only Group

Summary

The purpose of this study was to determine if OCA had an effect on cholesterol levels in the blood in participants with primary biliary cirrhosis (PBC).

Eligible Conditions
  • Primary Biliary Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 8/end of treatment (eot), week 12, month 6, month 12, month 18, month 24/eot
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8/end of treatment (eot), week 12, month 6, month 12, month 18, month 24/eot for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Area Under The Concentration-time Curve From Hour 0 To Last Sampling Time (Hour 6) (AUC0-6) For OCA And Conjugates
Maximum Plasma Concentration (Cmax) Of OCA And Conjugates
Median Change From Baseline In Alkaline Phosphatase
+14 more

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

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: OCA: 10 mgExperimental Treatment1 Intervention
Obeticholic acid, oral administration, 10 milligrams (mg), 8 weeks
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
16,953 Total Patients Enrolled
David Shapiro, MDStudy DirectorIntercept Pharmaceuticals
4 Previous Clinical Trials
268 Total Patients Enrolled
George Harb, MDStudy DirectorIntercept Pharmaceuticals, Inc.
6 Previous Clinical Trials
5,584 Total Patients Enrolled
~2 spots leftby Dec 2025
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