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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: Recruiting Phase 2 study of Nonalcoholic Steatohepatitis and Liver Fibrosis, sponsored by VA Office of Research and Development.
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 698-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To examine the efficacy of daily low dose Synthroid, using a dose-titration strategy based on serum thyroid stimulating hormone (TSH), on the histological progression of nonalcoholic steatohepatitis (NASH) in Veterans with normal serum TSH levels and biopsy-proven NASH, and to compare the treated patients with Veterans on placebo. Liver biopsies will be obtained at baseline (Week 0) and at end of treatment (Week 52). Nonalcoholic fatty liver disease activity score (NAS) will be assessed in basel
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 |
What NCT05526144 shows while recruiting
NCT05526144 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 698-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (82% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05526144's enrollment target sits among peer trials
128 15th of 30 higher than 16 of 30 other Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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