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New treatment option for MASH - Metabolic Dysfunction-Associated Steatohepatitis
Official title Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
ClinicalTrials.gov ID: NCT07335601
What this study is testing
What is Resmetirom?
Resmetirom is an investigational medicine, being studied as a potential treatment for mash - metabolic dysfunction-associated steatohepatitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- At least 12 months post-liver transplant at screening and meeting one of the following:
- Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF
- Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF
- Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive...
- MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy...
You likely can't join if
- Participation in another treatment clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to...
- Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
- FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa.
- Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
- Evidence of active liver disease other than MASH.
- History of liver transplantation for an inborn error of metabolism.
See the full eligibility criteria
- At least 12 months post-liver transplant at screening and meeting one of the following:
- Cohort 1: Liver transplant for MASH cirrhosis with recurrent hepatic steatosis ≥8% by MRI-PDFF
- Cohort 2: Liver transplant for non-MASH etiology with de novo hepatic steatosis ≥8% by MRI-PDFF
- Presence of at least one metabolic risk factor, including overweight/obesity, dysglycemia or type 2 diabetes, hypertension or antihypertensive treatment, hypertriglyceridemia or low HDL cholesterol, or lipid-lowering...
- MASH with moderate to advanced liver fibrosis (F2-F3), confirmed by noninvasive fibrosis assessment (FibroScan and/or MRE) and a liver biopsy consistent with Stage F2/F3 MASH and no evidence of other liver pathology or...
- Stable renal function with estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² prior to and during screening.
- Stable liver enzymes at screening, without clinically significant worsening compared with recent historical values.
- Stable immunosuppressive regimen for at least 3 months prior to screening.
- Females of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for at least 30 days after the last dose; females not of...
- Participation in another treatment clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screening.
- Phosphatidylethanol (PEth) value of ≥20 ng/mL measured at screening or clinically significant alcohol use within 1 year prior to screening.
- FibroScan VCTE \>20 kPa, a baseline biopsy demonstrating fibrosis consistent with F4, or MRE \> 5 kPa.
- Uncontrolled or clinically significant thyroid disease, including active hyperthyroidism or untreated hypothyroidism.
- Evidence of active liver disease other than MASH.
- History of liver transplantation for an inborn error of metabolism.
- Evidence of hepatic impairment or decompensation at screening.
- Steroid resistant rejection of the transplanted liver or kidney, or a history of a rejection treated with high dose steroid within 3 months of screening.
- Chronic rejection or chronic plasma-cell hepatitis.
- Significant post-transplant vascular or biliary complications.
- Significant cardiovascular or cerebrovascular disease within 6 months prior to randomization.
- Uncontrolled hypertension at screening or randomization.
- Current hepatocellular carcinoma.
- Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state.
- Any serious medical condition with a life expectancy of less than 5 years.
- Current substance abuse or drug addiction.
- Significant psychiatric, cognitive, or social conditions that would interfere with study participation or compliance, in the Investigator's judgment.
- Known hypersensitivity to study drug or any of its excipients.
- Use of prohibited concomitant medications that may affect liver function, steatosis, thyroid function, or study outcomes, or unstable doses of allowed metabolic therapies prior to randomization.
- Use of statins above protocol-allowed doses or unstable lipid-lowering therapy prior to randomization.
- Contraindications to MRI, including implanted devices incompatible with MRI, severe claustrophobia, or inability to undergo MRI procedures.
The study team makes the final eligibility decision.
Where it's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Chicago, Illinois, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- Manhasset, New York, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Murray, Utah, United States
- Charlottesville, Virginia, United States
- Toronto, Ontario, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Chicago, Illinois, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.