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Hormone Therapy
Thyroid Hormone for Nonalcoholic Steatohepatitis
Phase 2
Recruiting
Led By Jamal A Ibdah, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2
Scheduled for a medically indicated, diagnostic liver biopsy
Must not have
History of malignant hypertension
History of high degree AV block (Mobitz II or complete) in the absence of a pacemaker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
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.
Who is the study for?
Veterans with nonalcoholic steatohepatitis (NASH) who are overweight or obese, may have type 2 diabetes on stable medication, and exhibit features of metabolic syndrome. They must not drink more than a small amount of alcohol daily and agree to use effective birth control if applicable. Those with certain heart conditions, uncontrolled blood pressure, recent severe cardiovascular events, other liver diseases or cirrhosis are excluded.
What is being tested?
The trial is testing low dose thyroid hormone (Synthroid) against a placebo to see if it helps break down fat in the liver for Veterans with NASH. The study has two stages: an initial proof of concept followed by interim analysis which will determine whether the trial continues into stage two.
What are the potential side effects?
Potential side effects from Synthroid can include increased heart rate, sweating, sensitivity to heat, nervousness, headache, weight loss and possible impact on bone health. Side effects vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is 25.9 or higher, indicating I am overweight or obese.
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I am scheduled for a liver biopsy for diagnosis.
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I have at least 3 of these: central obesity, high blood pressure, low HDL, high triglycerides, or high blood sugar.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had dangerously high blood pressure.
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I have a serious heart block without a pacemaker.
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My adrenal glands are not functioning properly and it hasn't been treated.
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My heart's pumping ability is significantly reduced.
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My blood pressure is not higher than 160/100 mm Hg.
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I am not willing to stop taking certain antidepressants or ketamine for the study.
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I have not had a heart attack, unstable angina, heart surgery, or stroke in the last 3 months.
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I am currently taking Teduglutide or Midodrine.
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I do not have hepatitis from other causes like hepatitis B & C, autoimmune, or medication.
Select...
My heart rhythm is stable and my QTcF is within normal limits.
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I have cirrhosis with a bilirubin level above 1.3 mg/dL and an INR above 1.3.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points
Secondary study objectives
Improvement in mitochondrial biogenesis
Improvement in mitochondrial fatty acid oxidation
Improvement in mitochondrial mitophagy
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Study groupActive Control1 Intervention
Study group will receive Synthroid (Levothyroxine) 25, 50, or 75 mcg daily
Group II: Placebo groupPlacebo Group1 Intervention
Placebo group will receive placebo tablets
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,666 Previous Clinical Trials
3,765,681 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
148 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Jamal A Ibdah, MD PhDPrincipal InvestigatorHarry S. Truman Memorial, Columbia, MO
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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 been taking vitamin E or pioglitazone regularly for at least 6 months.My blood pressure is not higher than 160/100 mm Hg.I am not willing to stop taking certain antidepressants or ketamine for the study.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 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.I am taking digitalis and amiodarone and will consult my cardiologist for ongoing use during treatment.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 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.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo group
- Group 2: Study group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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.
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05526144 — Phase 2