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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 is a Phase 2 study of Familial Partial Lipodystrophy that has completed, run by Abhimanyu Garg. The registered enrollment target is 10 participants. The trial reports 2 study locations across 1 state.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02430077
The ClinicalTrials.gov registry entry for NCT02430077 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abhimanyu Garg, which has 1 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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