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FXR Agonist

Obeticholic Acid for Familial Partial Lipodystrophy

Phase 2
Waitlist Available
Led By Abhimanyu Garg, MD
Research Sponsored by Abhimanyu Garg
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, month4
Awards & highlights

Study Summary

This trial is studying the effect of a drug on reducing hepatic triglyceride levels in patients with hepatic steatosis and Familial Partial Lipodystrophy.

Eligible Conditions
  • Familial Partial Lipodystrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month4
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Liver Triglycerides (TG).
Secondary outcome measures
Change in Hepatic Insulin Sensitivity
Change in Serum Levels of Alanine Aminotransferase
Change in Serum Levels of Aspartate Aminotransferases
+3 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

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active capsule of Obeticholic acidExperimental Treatment1 Intervention
Patient will receive obeticholic acid (OCA) in the dose of 25 mg/day for a period of 4 months.
Group II: Pacebo for Obeticholic acidPlacebo Group1 Intervention
Patient will recieve placebo in the dose of 25 mg/day for a period of 4 months.
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?

Abhimanyu GargLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,765 Total Patients Enrolled
Abhimanyu Garg, MDPrincipal Investigator - UT Southwestern Medical Center
The University of Texas Southwestern Medical Center At Dallas, VA North Texas Health Care System-Dallas VA Medical Center
All India Inst Of Medical Sci (Medical School)
5 Previous Clinical Trials
47 Total Patients Enrolled

Frequently Asked Questions

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

Might I be suited for this research?

"The ideal candidate for this clinical trial would have lipodystrophy, be familial partial, and between 18-70 years old. So far, 13 individuals have been accepted into the study."

Answered by AI

Are there any other instances in which Obeticholic Acid has been tested?

"There are currently seven clinical trials underway for Obeticholic Acid, two of which are in Phase 3.Though the majority of these studies originate from Changchun, Jilin, there are a total of 424 locations running active trials for this medication."

Answered by AI

How many people are total participating in this research project?

"Unfortunately, this study is no longer admitting patients. The listing was created on June 1st, 2016 but the most recent update was on January 23rd, 2022. If you are interested in other studies, there are currently 21 trials for lipodystrophy and 7 for Obeticholic Acid that are still looking for participants."

Answered by AI

When was the last time that Obeticholic Acid went through FDA approval?

"While there is some evidence of safety, as this is a Phase 2 trial, no data currently supports Obeticholic Acid's efficacy. Our team at Power gave it a score of 2."

Answered by AI

Are participants still being sought for this experiment?

"28 other clinical trials are actively recruiting, this one is not. As stated onclinicaltrials.gov, the last update to this trial was on 1/23/2022 and it's status is "not recruiting"."

Answered by AI

Does this experiment have an age limit?

"The age limit to participate in this clinical trial is 70 years old, provided that the patient is an adult aged 18 or older."

Answered by AI

To your knowledge, has anything like this been done before?

"According to publically available data, there are 7 active clinical trials for Obeticholic Acid. These studies span 142 cities and 31 countries. The initial trial was sponsored by Intercept Pharmaceuticals in 2015. That study completed its Phase 3 drug approval stage and involved 2480 participants. Since that time, 18300 additional trials have been conducted worldwide."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
Abhimanyu Garg 2016. "Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02430077.
~1 spots leftby Apr 2025
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