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Hormone Therapy

Thyroid Hormone for Nonalcoholic Steatohepatitis in Veterans

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
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
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up12 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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Liver Fibrosis

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You cannot consume more than 20 grams of alcohol per day.
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Both men and women, regardless of age or 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
1,584 Previous Clinical Trials
2,897,580 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
Recent research and studies
clinicaltrials.govStudy
Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
2023. "Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05526144.
All > Fatty Liver Disease > Montreal
~85 spots leftby Mar 2029
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