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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) | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

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)

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)

NCT04951219•Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (71)

Central Research Associates

Birmingham, Alabama, United States

Arizona Liver Health - Chandler

Chandler, Arizona, United States

East Valley Family Physicians

Chandler, Arizona, United States

The Institute For Liver Health - Glendale

Glendale, Arizona, United States

The Institute For Liver Health - Tucson

Tucson, Arizona, United States

Adobe Gastroenterology

Tucson, Arizona, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Fresno Clinical Research Center

Fresno, California, United States

National Research Institute - Huntington Park

Huntington Park, California, United States

Ruane Clinical Research Group

Los Angeles, California, United States

Key Dates

Start Date

July 9, 2021

Primary Completion Date

March 1, 2026

Completion Date

April 1, 2026

Last Updated

August 3, 2025

Enrollment

1,000

ESTIMATED participants

Conditions

Non-Alcoholic Fatty Liver Disease

Interventions

Resmetirom

DRUG

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

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RECRUITINGPHASE3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

NCT07221227

Non-alcoholic Fatty Liver Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Accuracy of Imaging Techniques in Diagnosing Steatohepatitis and Fibrosis in NAFLD Patients

Nonalcoholic Steatohepatitis in Chinese Children

OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities