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Evaluating Resmetirom for Non-Alcoholic Fatty Liver Disease

A 52-Week, Phase 3, Open-Label Extension Study, With a Double-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)

Phase 3 Interventional Madrigal Pharmaceuticals, Inc. · NCT04951219

This study is testing a new oral medication called Resmetirom to see if it can safely help people with Non-Alcoholic Fatty Liver Disease over a year.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorMadrigal Pharmaceuticals, Inc. Industry-sponsored
Locations74 sites (Birmingham, Alabama and 73 other locations)
Trial IDNCT04951219 on ClinicalTrials.gov

What this trial studies

This phase 3 study assesses the safety and tolerability of Resmetirom, an oral medication, in patients with Non-Alcoholic Fatty Liver Disease (NAFLD) over a 52-week period. Participants include those who completed a prior study and meet specific liver biopsy criteria. The study aims to gather data on biomarkers and the overall effectiveness of the treatment in managing NAFLD. It is conducted at multiple centers to ensure a diverse patient population.

Who should consider this trial

Good fit: Ideal candidates are patients who have completed the MAESTRO-NAFLD-1 study and meet specific liver biopsy criteria.

Not a fit: Patients with liver biopsy results that do not meet the eligibility criteria for this study may not benefit.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and overall outcomes for patients with NAFLD.

How similar studies have performed: Previous studies have shown promise in treating NAFLD with similar approaches, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Birmingham, Alabama and 73 other locations

+24 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Non-Alcoholic Fatty Liver DiseaseNAFLDNASHHyperlipidemiaResmetiromThyroid hormone receptor betaHepaticFibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.