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New treatment option for Nonalcoholic Steatohepatitis
Official title Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
ClinicalTrials.gov ID: NCT05526144
What this study is testing
What is Synthroid?
Synthroid is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nonalcoholic steatohepatitis.
Also referred to as Levothyroxine, T4.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Men and women (pre- and post-menopausal)
- Overweight/obese people 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
You likely can't join if
- Other causes of hepatitis including hepatitis B \& C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin...
- 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
See the full eligibility criteria
- Men and women (pre- and post-menopausal)
- Overweight/obese people 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.