A 52-Week, Phase 3, Open-Label Extension Study, With a Single-blind Lead-in, 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)

  • End date
    Apr 21, 2024
  • participants needed
  • sponsor
    Madrigal Pharmaceuticals, Inc.
Updated on 21 October 2022


A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)

Condition Non-Alcoholic Fatty Liver Disease
Treatment Resmetirom
Clinical Study IdentifierNCT04951219
SponsorMadrigal Pharmaceuticals, Inc.
Last Modified on21 October 2022


Yes No Not Sure

Inclusion Criteria

Must have participated in 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 the Extension study and provide written informed consent
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 with F2 or F3
NAS = 3, ballooning 0 with F2 or F3
NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)

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
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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