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NCT05526144 · ClinicalTrials.gov registry record · Phase 2
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
A Phase 2 study of Nonalcoholic Steatohepatitis and Liver Fibrosis, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
- 1
- Study location
NCT05526144 is a Phase 2 study of Nonalcoholic Steatohepatitis and Liver Fibrosis that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 128 participants, below the 1,023-participant average among 17 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05526144, a Phase 2 study of Nonalcoholic Steatohepatitis and Liver Fibrosis, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
- 1
- Study location
Study Summary
Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Synthroid
Study Locations (1)
Missouri
- Harry S. Truman Memorial, Columbia, MO - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2023-04-01 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05526144
The ClinicalTrials.gov registry entry for NCT05526144 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,023-participant average among 17 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (87% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05526144 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05526144 about?
NCT05526144 is a clinical study titled "Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans". Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease an...
What is the current status of trial NCT05526144?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2023-04-01. Estimated completion is 2029-12-31.
What conditions does trial NCT05526144 study?
This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis, Liver Fibrosis.
What interventions are being tested in trial NCT05526144?
The interventions under investigation include: Placebo (DRUG), Synthroid (DRUG).
Who is sponsoring clinical trial NCT05526144?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05526144 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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