NCT05526144 Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 128 participants in total. It began in 2023-04-01 with a primary completion date of 2029-12-31.

Brief 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.

Eligibility Criteria

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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