Testing Resmetirom against a placebo for MASH - metabolic dysfunction-associated steatohepatitis

Exclusion

• −Known hypersensitivity to study drug or any of its excipients.
• −Chronic rejection or chronic plasma-cell hepatitis.
• −Known human immunodeficiency virus (HIV) infection or other clinically significant immunocompromised state.
• −Participation in another interventionalInterventional studyA study where participants are given something to see what happens.Read more → clinical trial with investigational drug exposure within 30 days (or 5 half-lives, whichever is longer) prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• −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 baselineBaselineYour starting measurements, taken before treatment begins.Read more → 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.
• −Significant post-transplant vascular or biliary complications.
• −Significant cardiovascular or cerebrovascular disease within 6 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
• −Uncontrolled hypertension at screening or randomization.
• −Current hepatocellular carcinoma.
• −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 InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s judgment.
• −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 protocolProtocolThe detailed plan a study must follow.Read more →-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.