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Thyroid Hormone for Nonalcoholic Steatohepatitis in Veterans

This study is looking into whether a low dose of thyroid hormone, specifically Synthroid, can help Veterans with Nonalcoholic Steatohepatitis (NASH). NASH is a serious liver condition that is more common in Veterans and can lead to severe liver disease. Participants will receive either Synthroid (at a dose of 25, 50, or 75 mcg daily) or a placebo (an inactive pill) for one year. The Synthroid dose will be adjusted to keep your thyroid hormone levels normal. Researchers will measure if the treatment improves your Nonalcoholic Fatty Liver Disease Activity Score (NAS) after one year. You may be able to join if you are a man or woman between 18 and 75 years old, are overweight or obese, and have certain other health conditions like type 2 diabetes. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 128 participants. Participants will be randomly assigned to receive either Synthroid or a placebo.
What's involved
Participants will take study tablets daily for one year. The study will involve regular monitoring to adjust the Synthroid dose and assess the Nonalcoholic Fatty Liver Disease Activity Score.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 months, indicating a follow-up period of at least one year.

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NCT05526144

Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans

Recruiting
PHASE2Ages 18–75InterventionalTreatment
VA Office of Research and Development
~128 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:SynthroidPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points
Measured over 12 months

Conditions

Nonalcoholic Steatohepatitis
Liver Fibrosis

Explore related trials

Liver FibrosisNonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • Jamal A Ibdah, MD PhD · PRINCIPAL_INVESTIGATOR · Harry S. Truman Memorial, Columbia, MO

Who to contact

Adam T Whaley-Connell, DO MSPH
[email protected]
(573) 814-6552
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points12 months

    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 baseline and post treatment liver biopsies and improvement in NAS will be compared between study group on active treatment and placebo group.