Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
Recruiting · 17 sites across 12 states
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?
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH. Cohort 2 will consist of subjects who have undergone liver transplant for indications other than MASH cirrhosis who developed de novo MASH.
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…
- •Be at least 12 months after a liver transplant (checked at screening).
- •Have MASH with moderate to advanced fibrosis (F2-F3) confirmed by noninvasive tests and a liver biopsy.
- •Have enough liver fat on MRI-PDFF (at least 8%) after transplant, based on which transplant reason they had.
- •Have at least one metabolic risk factor such as overweight/obesity, blood sugar problems or type 2 diabetes, high blood pressure, or abnormal blood fats.
- •Have stable kidney function and stable liver enzyme levels, and stay on a stable immunosuppressive regimen for at least 3 months before screening.
🚫 You may not be able to join if…
- •Have participated in another drug trial with an investigational drug within 30 days (or 5 half-lives, whichever is longer) before screening.
- •Have heavy alcohol use in the last year or an abnormal PEth blood test (PEth ≥20 ng/mL).
- •Have advanced scarring that is F4, or have FibroScan VCTE >20 kPa, or MRE >5 kPa.
- •Have uncontrolled or clinically significant thyroid disease (including active hyperthyroidism or untreated hypothyroidism).
- •Have certain other serious issues, such as current hepatocellular carcinoma, HIV/immunocompromised state, uncontrolled high blood pressure, active liver disease other than MASH, or cannot have MRI.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 18–75
- ✓Have Obesity / overweight or Type 2 diabetes or Fatty liver disease (NASH/MASH) or High blood pressure or Kidney disease
- !Some conditions may not be a fit: Heart / cardiovascular disease
What to expect, step by step
- 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
If 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.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant. Cohort 1 will consist of patients who have undergone liver transplant for MASH cirrhosis who developed recurrent MASH.
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. This study may also compensate you for your time and travel — the team will tell you the amount before you join. 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 · NCT07335601 · Locations: California · Colorado · District of Columbia · Illinois · Minnesota · Nebraska · New York · Tennessee · Texas · Utah · Virginia · Ontario