A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

Launched by MADRIGAL PHARMACEUTICALS, INC. · Jul 2, 2021

Keywords

ClinConnect Summary

The MAESTRO-NAFLD-OLE clinical trial is studying a medication called Resmetirom (MGL-3196) to see how safe and effective it is for people with Non-Alcoholic Fatty Liver Disease (NAFLD). This trial is for patients who have already participated in a previous study (MAESTRO-NAFLD-1) and is currently recruiting individuals aged 65 to 74. To join, participants need to have completed their Week 52 and Week 56 visits in the earlier study and provide written consent. Those who didn't qualify for another related study (MAESTRO-NASH) can also join if they meet specific liver health criteria.

Participants in this trial will take Resmetirom once a day for one year and will be closely monitored for any side effects and how their liver health changes. It's important to note that individuals with significant alcohol use, certain types of cancer, chronic liver diseases, or active autoimmune diseases may not be eligible to participate. This study aims to gather valuable information that could help improve treatments for NAFLD in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent.
• * For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results:
• • NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
• • NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
• • Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD \<12, albumin ≥3.2, and bilirubin \<2
• • For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score \<8) NASH cirrhosis (including minimal decompensation) and MELD \<15 unless MELD \>=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE .
• Exclusion Criteria:
• • A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1.
• • Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study.
• • Chronic liver diseases
• • Has an active autoimmune disease
• • Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.