Could a tiny dose of thyroid hormone heal fatty liver disease?
NCT ID NCT05526144
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a low dose of the thyroid hormone Synthroid can help treat nonalcoholic steatohepatitis (NASH), a serious liver condition common in Veterans. About 128 overweight or obese Veterans with NASH will take either Synthroid or a placebo daily for one year. The goal is to see if the hormone improves liver fat breakdown and reduces liver damage and scarring.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Synthroid (levothyroxine, a thyroid hormone)
- What this could lead to
- If it works, this could provide a new, well-tolerated treatment option for NASH, potentially slowing or reversing liver damage in Veterans.
- What could go wrong
- This is an early phase 2 trial with only 128 participants, so results may not apply broadly. The treatment may not improve liver health, and there are risks from thyroid hormone dosing, though doses are low and monitored.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2023
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a US federal agency other than the NIH.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Men and women (pre- and post-menopausal) * Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2 * Alcohol intake \< 20 grams per day * Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment * Patients who are treated with vitamin E or pioglitazone should be on stable doses for at least 6 months before enrollment * Features of metabolic syndrome: 3 or more (central obesity, hypertension, low HDL, high triglycerides, high fasting glucose) * Scheduled for a medically indicated, diagnostic liver biopsy * Female patients are eligible if they are of reproductive potential and have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use two highly effective birth control methods during the study OR if they are not of child-bearing potential (i.e., surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\> 12 consecutive months without menses\]) * Highly effective birth control methods include condoms with spermicide, diaphragm with spermicide, hormonal and nonhormonal intrauterine device, hormonal contraception (estrogens stable for at least 3 months), a vasectomized male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from screening, throughout the study, and for at least 30 days after the last dose of study drug administration * Reliance on abstinence from heterosexual intercourse is acceptable only if it is the patient's habitual practice * If a patient is on digitalis and amiodarone, he/she is expected to use/continue these medications throughout the treatment period only after consultation with their cardiologist for monitoring and dose adjustments if necessary Exclusion Criteria: * Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis * Alcohol consumption of 20 g/d or more * Patients with cirrhosis, bilirubin of 1.3 mg/dL or more, and INR of 1.3 or more * Evidence of Portal hypertension * Pregnancy * History of malignant hypertension * Uncontrolled hypertension (either treated or untreated) defined as systolic blood pressure \> 160 mm Hg or a diastolic blood pressure \> 100 mm Hg at screening * New York Heart Association Class III or IV heart failure or known left ventricular ejection fraction \< 30% * Uncontrolled cardiac arrhythmia, including confirmed QT interval corrected using Fridericia's formula (QTcF) \> 450 msec for males and \> 470 msec for females at the screening electrocardiogram (ECG) assessment * History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, or stroke within at least 3 months prior to randomization * History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker * Patients with uncorrected adrenal insufficiency * Patients who are on tricyclic or tetracyclic antidepressants or ketamine, if they are unwilling and/or unable to discontinue these medications to allow adequate washout prior to randomization * Patients who are on Teduglutide or Midodrine
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Harry S. Truman Memorial, Columbia, MO
RECRUITINGColumbia, Missouri, 65201-5275, United States
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Other studies related to the condition(s) this trial covers.
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