Thyroid Hormone for Treatment of Nonalcoholic Steatohepatitis in Veterans
Recruiting · Columbia, Missouri
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
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.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
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. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Men and women (before or after menopause)
- •BMI is 25.9 or higher (overweight/obese)
- •Drink less than 20 grams of alcohol per day
- •Have NASH and are scheduled for a medically needed diagnostic liver biopsy
- •If a person has type 2 diabetes, they must be on stable diabetes medicines for at least 3 months before joining
🚫 You may not be able to join if…
- •Have other causes of liver inflammation (including hepatitis B or C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson’s disease, alpha-1-antitrypsin deficiency, or medicine-induced hepatitis)
- •Drink 20 grams of alcohol per day or more
- •Have cirrhosis, or high bilirubin (≥ 1.3 mg/dL) or high INR (≥ 1.3)
- •Are pregnant or breastfeeding (or plan to become pregnant during the study)
- •Have certain serious heart problems (for example, uncontrolled high blood pressure, certain heart failure, very abnormal QTc on ECG, or major heart events/stroke within the past 3 months)
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults with nonalcoholic steatohepatitis (NASH/MASH)
- ✓BMI of 25.9 or higher (overweight/obese)
- ✓Alcohol intake under 20 grams per day
- ✓Type 2 diabetes (if present) on stable meds for at least 3 months
- ✓For women who can become pregnant: negative pregnancy test and reliable birth control; not breastfeeding
- !Some conditions may not be a fit: Heart / cardiovascular disease
- !Not for people who are pregnant or breastfeeding
How this study is designed
The real details, in plain words. Tap the underlined words to learn what they mean.
- •Some participants receive a . The study team tells you your chances of getting the active treatment before you decide.
- •You'd be placed into a group by chance, like a coin flip — this keeps the study fair.
- •This study is , so results can't be swayed by expectations. Your medical team always knows what you're getting.
- •There are 2 groups in this study.
What to expect, step by step
· This study lasts about 52 weeks (~12 months)- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
About 52 weeksIf you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
What's being tested
- Drug: Synthroid
- Drug: Placebo
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
Who's running this study?
Sponsor
VA Office of Research and Development
Overseen by Jamal A Ibdah, MD PhD
Every study is also reviewed by an independent that protects participants.
What you need to know before you apply
What is this study 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.
Is it safe? Who makes sure of that?+
This is a mid-stage study (Phase 2), looking at safety and whether the treatment works. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT05526144 · Locations: Missouri