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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
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])
Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

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.Check my eligibility
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.See study design
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 below
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I am not pregnant, breastfeeding, or planning to become pregnant and will use birth control, or I cannot become pregnant.
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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: belly fat, high blood pressure, low HDL, high triglycerides, or high blood sugar.
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I have been taking vitamin E or pioglitazone regularly for at least 6 months.
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My BMI is 26 or higher.
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I am taking digitalis and amiodarone and will consult my cardiologist for ongoing use during treatment.
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I am using or willing to use effective birth control during and after the study.
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I have type 2 diabetes and have been on a stable medication dose for 3 months.
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I have at least 3 of these: central obesity, high blood pressure, low HDL, high triglycerides, or high blood sugar.
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I am scheduled for a liver biopsy for diagnosis.
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I regularly practice abstinence as my form of birth control.
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I am a man or a woman, regardless of my menopausal status.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement in Nonalcoholic fatty liver disease activity score (NAS) by 2 points
Secondary outcome measures
Improvement in mitochondrial biogenesis
Improvement in mitochondrial fatty acid oxidation
Improvement in mitochondrial mitophagy
+1 more

Trial 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
1,606 Previous Clinical Trials
3,305,877 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
116 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Jamal A Ibdah, MD PhDPrincipal InvestigatorHarry S. Truman Memorial, Columbia, MO

Media Library

Synthroid (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05526144 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo group, Study group
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: Synthroid Highlights & Side Effects. Trial Name: NCT05526144 — Phase 2
Synthroid (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05526144 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05526144 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Indiana
Illinois
New York
What site did they apply to?
Harry S. Truman Memorial, Columbia, MO
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I will think the same answer only to help my liver. I have lost weight and am exercising more.I would like to try the drug that you are testing .
PatientReceived 2+ prior treatments
I am interested in learning more about the diseases, how I got my current status, what I can do to keep trying to live a long healthy life. Since it would be close to 190 miles to travel, would it be possible to consolidate visits. I just completed a 6-year study on Alzheimer's new trial drug for Eli Lilly at Washington University, St. Louis.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long are the visits, what is the screening process? My husband would be coming with me, also. What is the length of the study?
PatientReceived 2+ prior treatments
~85 spots leftby Mar 2029