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Thyroid Hormone for Nonalcoholic Steatohepatitis
Study Summary
This trial is testing whether low-dose thyroid hormone can help treat NASH by improving fat breakdown in mitochondria. The study will happen in two stages, with an interim analysis to determine if the trial should continue. If successful, this could provide new information and strategies for treating NASH in Veterans.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My BMI is 25.9 or higher, indicating I am overweight or obese.I am scheduled for a liver biopsy for diagnosis.I have had dangerously high blood pressure.I have a serious heart block without a pacemaker.My adrenal glands are not functioning properly and it hasn't been treated.My heart's pumping ability is significantly reduced.I am not pregnant, breastfeeding, or planning to become pregnant and will use birth control, or I cannot become pregnant.I have at least 3 of these: belly fat, high blood pressure, low HDL, high triglycerides, or high blood sugar.I am not pregnant, breastfeeding, or planning to become pregnant and will use birth control, or I cannot become pregnant due to surgery or menopause.I have been taking vitamin E or pioglitazone regularly for at least 6 months.I am using or willing to use effective birth control during and after the study.My blood pressure is not higher than 160/100 mm Hg.I have type 2 diabetes and have been on a stable medication dose for 3 months.I am taking digitalis and amiodarone and will consult my cardiologist for ongoing use during treatment.I am not willing to stop taking certain antidepressants or ketamine for the study.I am a man or a woman, regardless of my menopausal status.I have not had a heart attack, unstable angina, heart surgery, or stroke in the last 3 months.I am currently taking Teduglutide or Midodrine.I regularly practice abstinence as my form of birth control.I do not have hepatitis from other causes like hepatitis B & C, autoimmune, or medication.My heart rhythm is stable and my QTcF is within normal limits.My BMI is 26 or higher.I am taking digitalis and amiodarone and will consult my cardiologist for ongoing use during treatment.I have been taking vitamin E or pioglitazone for at least 6 months.I am using or willing to use effective birth control during and after the study.I have type 2 diabetes and have been on a stable medication dose for 3 months.I have at least 3 of these: central obesity, high blood pressure, low HDL, high triglycerides, or high blood sugar.You cannot consume more than 20 grams of alcohol per day.I am scheduled for a liver biopsy for diagnosis.I have cirrhosis with a bilirubin level above 1.3 mg/dL and an INR above 1.3.I regularly practice abstinence as my form of birth control.I am a man or a woman, regardless of my menopausal status.
- Group 1: Placebo group
- Group 2: Study group
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA okayed this research project?
"While there is some data indicating that Study group is safe, it does not yet have any evidence of efficacy and thus receives a score of 2."
Am I eligible to participate in this clinical research?
"Eligible patients for this trial must have fibrosis, liver damage, and be aged between 18-75. This study will accept a maximum of 128 participants."
Are people currently being signed up for this experiment?
"The clinical trial in question is not searching for participants at this moment, as per the information found on clinicaltrials.gov. This study was initially posted on 1/1/2023 and was most recently edited on 8/30/2022. There are 437 other trials that are currently enrolling patients."
Can elderly people participate in this research project?
"According to the inclusion criteria for this clinical trial, patients aged 18-75 may qualify to participate. There are 37 other trials available for children and 384 trials available for elderly patients."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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