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NCT00596934 · ClinicalTrials.gov registry record · Phase 2
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study of Fatty Liver Disease, Nonalcoholic, sponsored by Elif Oral.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 1
- Study location
NCT00596934 is a Phase 2 study of Fatty Liver Disease, Nonalcoholic that has completed, run by Elif Oral. The registered enrollment target is 9 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00596934, a Phase 2 study of Fatty Liver Disease, Nonalcoholic, has completed, sponsored by Elif Oral.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 1
- Study location
Study Summary
Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons. It is often associated with resistance to the actions of insulin hormone. Fat cells secrete a hormone called leptin. Recently, we have learned that obese or overweight persons make too much leptin, which may contribute to insulin resistance. Paradoxically, patients who do not have any fat cells, also have insulin resistance. In these patients, insulin resistance is caused by the absence of leptin and leptin replacement significantly improves insulin resistance and fat deposition in the liver. In an earlier study, we determined the leptin levels in patients with NASH and how these levels are related to body fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH have relatively low levels of leptin in contrast to the amount of body fat they had. We now would like to see if restoring leptin levels to normal will improve the disease process in these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive), who do not have any other cause for their liver disease. We have put some restrictions in body size such that a spectrum of patients from normal weight to obese range would be included. They will also demonstrate low leptin levels (levels similar to only 25% of normal population). We will use a genetically engineered form of leptin manufactured by Amylin Inc. given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters and body composition characteristics that we examined in our earlier study. We expect that patients with low blood leptin levels will show improvement in their liver disease and insulin resistance when their blood leptin levels are restored to normal.
Conditions Studied
Interventions
- DRUG metreleptin
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-02 |
| Est. Completion | 2009-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00596934
The ClinicalTrials.gov registry entry for NCT00596934 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elif Oral, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Fatty Liver Disease, Nonalcoholic appearing as the primary indexed condition, and to 1 intervention - of which metreleptin is the first listed.
NCT00596934 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT00596934 about?
NCT00596934 is a clinical study titled "Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)". Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the liver and development of scarring. This condition occurs more frequently in overweight and obese persons. It is often associated with resistance to the actions of insulin hormone. Fat cells secrete a hormone cal...
What is the current status of trial NCT00596934?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2006-02. Estimated completion is 2009-03.
What conditions does trial NCT00596934 study?
This clinical trial studies the following conditions: Fatty Liver Disease, Nonalcoholic.
What interventions are being tested in trial NCT00596934?
The interventions under investigation include: metreleptin (DRUG).
Who is sponsoring clinical trial NCT00596934?
This trial is sponsored by Elif Oral, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00596934 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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