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)

Running, not enrolling · Phase 3

Conditions studied: Non-Alcoholic Fatty Liver Disease

In brief

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)

Key facts

Study ID

NCT04951219

Run by

Madrigal Pharmaceuticals, Inc.

People needed

810

Starts

2021-07-09

Expected to finish

2027-04-01

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 .

You may not qualify if…

• 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 it is running

• 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
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• National Research Institute - Los Angeles — Los Angeles, California, United States
• National Research Institute - Panorama City — Panorama City, California, United States
• San Fernando Valley Health Institute — West Hills, California, United States
• South Denver Gastroenterology - Swedish Medical Center Office — Englewood, Colorado, United States
• Excel Medical Clinical Trials — Boca Raton, Florida, United States
• Covenant Research — Fort Myers, Florida, United States
• Velocity Clinical Research, Hallandale Beach (MD Clinical) — Hallandale, Florida, United States
• Floridian Clinical Research — Hialeah, Florida, United States
• Nature Coast Clinical Research - Inverness — Inverness, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Floridian Clinical Research — Miami Lakes, Florida, United States
• Orlando Research Center — Orlando, Florida, United States
• Progressive Medical Research — Port Orange, Florida, United States
• Central Research Associates — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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