Actively Recruiting
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
Led by VA Office of Research and Development · Updated on 2026-02-19
128
Participants Needed
1
Research Sites
352 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women (pre- and post-menopausal)
- Overweight or obese with BMI at or above 25.9 kg/m2
- Alcohol intake less than 20 grams per day
- Type 2 diabetes patients on stable medication doses for at least 3 months
- Patients on vitamin E or pioglitazone on stable doses for at least 6 months
- Metabolic syndrome with 3 or more features (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose)
- Scheduled for a medically indicated diagnostic liver biopsy
- Female patients of reproductive potential must have a negative pregnancy test, not breastfeeding, not planning pregnancy during study, and agree to use two effective birth control methods or be naturally or surgically sterile
- Patients on digitalis and amiodarone must continue medications with cardiologist consultation for monitoring and dose adjustments
You will not qualify if you...
- Other causes of hepatitis (B, C, autoimmune, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced)
- Alcohol consumption of 20 grams per day or more
- Cirrhosis, bilirubin 1.3 mg/dL or higher, or INR 1.3 or higher
- Evidence of portal hypertension
- Pregnancy
- History of malignant hypertension
- Uncontrolled hypertension (systolic >160 mm Hg or diastolic >100 mm Hg)
- New York Heart Association Class III or IV heart failure or left ventricular ejection fraction below 30%
- Uncontrolled cardiac arrhythmia including prolonged QT interval
- Recent myocardial infarction, unstable angina, coronary interventions, or stroke within 3 months prior to randomization
- History of high degree AV block without pacemaker
- Uncorrected adrenal insufficiency
- Use of tricyclic or tetracyclic antidepressants or ketamine without willingness or ability to discontinue prior to randomization
- Use of Teduglutide or Midodrine
AI-Screening
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Trial Site Locations
Total: 1 location
1
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, United States, 65201-5275
Actively Recruiting
Research Team
A
Adam T Whaley-Connell, DO MSPH
CONTACT
J
Jennifer A Atherton
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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