A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)

Launched by MADRIGAL PHARMACEUTICALS, INC. · Aug 11, 2022

Keywords

ClinConnect Summary

The MAESTRO-NASH-OUTCOMES clinical trial is studying how well a medication called resmetirom works for patients with a specific liver condition known as well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis. This trial is looking to see if taking 80 mg of resmetirom once a day can improve health outcomes for these patients. Specifically, the researchers will measure how long it takes for participants to experience certain health events related to their liver condition.

To be eligible for this study, participants should be between the ages of 65 and 74, have confirmed NASH cirrhosis, and be in a stable condition without significant liver complications. They also need to have at least three metabolic risk factors, which can include conditions like obesity or type 2 diabetes. Participants will be monitored closely throughout the trial, and the study is currently recruiting both men and women. If you or someone you know fits these criteria and is interested in learning more about the trial, it could be a valuable opportunity to help advance treatment options for this liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Definitive (by histologic documentation) or probable NASH as causative agent for cirrhosis, following a modified version of the NASH Cirrhosis: Liver Forum Consensus Definitions for Clinical Trials.
• • a. Most recent biopsy (within last 5 years) shows cirrhosis with a NAS of ≥ 2, and at least two components: one being steatosis and at least one other component; OR NAS of ≥ 2, if steatosis = 0 or is ungraded with inflammation and/or ballooning, eligible with an MRI-PDFF \>5%. If steatosis and ballooning and/or steatosis and inflammation are noted by the local pathologist, then the biopsy qualifies even if a NAS is not provided (Approximately 70% of the study patient population) b. Historical biopsy (within last 5 years) showed NASH with significant fibrosis with pathology report documenting "F2" or "F3", with at least steatosis either by biopsy with no minimal percentage required or by MRI-PDFF \>5%, AND inflammation or ballooning. Now with cirrhosis, either by clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7) (Up to approximately 20% of study patient population) c. Historical biopsy (within last 5 years) shows steatosis. Pathology report documents steatosis with no minimal percentage required. Now with cirrhosis, either by clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7). Prescreening metabolic risk factors must include obesity and/or T2D. (Up to approximately 10% of study patient population.)
• • Well-compensated NASH cirrhosis at screening and baseline with Child-Pugh A (score of 5-6) (no history of hepatic decompensation event).
• • At least 3 metabolic risk factors
• • Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) that is obtained during the Screening period or a historic MRI-PDFF at ≤8 weeks old at the time of randomization with no weight change ≥5% weight change in that interval.
• • MRE ≥4.2 where MRE is available.
• • Enhanced liver function (ELF) ≥9.8, only if MRE is unavailable or contraindicated.
• Exclusion Criteria:
• • Participants with a chronic liver diseases other than NASH cirrhosis, such as primary biliary cholangitis, primary sclerosing cholangitis, Hepatitis B positive, Hepatitis C, history or evidence of current active autoimmune hepatitis, history or evidence of Wilson's disease, history or evidence of alpha-1-antitrypsin deficiency, history or evidence of genetic hemochromatosis (hereditary, primary), evidence of drug-induced liver disease, as defined on the basis of typical exposure and history, known bile duct obstruction, or suspected or confirmed liver cancer, are excluded.
• • Participants with MELD score ≥12 due to liver disease are excluded.
• • Participants with a history of hepatic decompensation or impairment are excluded.