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NCT02430077 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
A Phase 2 study of Familial Partial Lipodystrophy, sponsored by Abhimanyu Garg.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 2
- Study locations
NCT02430077: Completed Phase 2 study of Familial Partial Lipodystrophy, sponsored by Abhimanyu Garg.
NCT02430077 is a Phase 2 study of Familial Partial Lipodystrophy that has completed, run by Abhimanyu Garg. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02430077, a Phase 2 study of Familial Partial Lipodystrophy, has completed, sponsored by Abhimanyu Garg.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 2
- Study locations
Study Summary
Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a common complication in patients with partial and generalized lipodystrophies.Despite aggressive management of diabetes and hyperlipidemia, hepatic steatosis and its complications present a therapeutic challenge in many patients. Due to this large disease burden, it is important to assess the efficacy and safety of novel therapies for hepatic steatosis in patients with lipodystrophies.There are, however, no systematic studies evaluating various therapeutic interventions for reducing hepatic steatosis in patients with lipodystrophies. A variety of drugs have been investigated in nonlipodystrophic patients with non-alcoholic hepatic steatosis and steatohepatitis (NASH) or non-alcoholic fatty liver disease (NAFLD). Recent data support the activation of the farnesoid X receptor (FXR, NR1H4), a nuclear hormone receptor regulated by bile acids, for treatment of NASH and NAFLD. FXR activates transcription of several genes particularly the atypical nuclear receptor small heterodimer partner (SHP, NR0B2) and thus can influence triglyceride metabolism within hepatocytes.Both cholic acid (CA) and chenodeoxycholic acid (CDCA) are ligands for FXR, however, UDCA which is the 7 hydroxy β-epimer of CDCA, does not activate FXR. Obeticholic acid (OCA) is a first-in-class selective FXR agonist which has approximately 100 fold greater FXR-agonistic activity in the nanomolar range, as compared to CDCA .It therefore appears that FXR modulation offers interesting therapeutic possibilities in treating hepatic steatosis. This study is primarily designed to study efficacy of OCA, a strong FXR ligand, in reducing hepatic triglyceride levels in patients with hepatic steatosis and Familial Partial Lipodystrophy (FPLD). If proven to be effective, it may reduce morbidity and mortality as a result of sequelae of hepatic
Primary Outcome
The primary end-point variable was the change in the liver TG content assessed using proton-density fat fraction mapping by Magnetic Resonance Imaging (MRI).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid
Study Locations (2)
Texas
- UT Southwestern Medical Center 5323 Harry Hines Blvd - Dallas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-06 |
| Est. Completion | 2022-12 |
| Phase | Phase 2 |
What the finished NCT02430077 record still lists
NCT02430077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Familial Partial Lipodystrophy appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02430077 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02430077 about?
NCT02430077 is a clinical study titled "Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients". Lipodystrophies are rare disorders characterized by selective loss of adipose tissue and predisposition to insulin resistance and its metabolic complications. Hepatic steatosis is a common complication in patients with partial and generalized lipodystrophies.Despite aggressive management of diabetes...
What is the current status of trial NCT02430077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2016-06. Estimated completion is 2022-12.
What conditions does trial NCT02430077 study?
This clinical trial studies the following conditions: Familial Partial Lipodystrophy.
What interventions are being tested in trial NCT02430077?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (DRUG).
Who is sponsoring clinical trial NCT02430077?
This trial is sponsored by Abhimanyu Garg, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02430077 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02430077's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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Source ClinicalTrials.gov registry export · 2026-08-08
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