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)

Description

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)

Conditions

Non-Alcoholic Fatty Liver Disease

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Study Overview

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Study Details

Study overview

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)

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)

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)

Condition
Non-Alcoholic Fatty Liver Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

Central Research Associates, Birmingham, Alabama, United States, 35205

Chandler

Arizona Liver Health - Chandler, Chandler, Arizona, United States, 85224

Chandler

East Valley Family Physicians, Chandler, Arizona, United States, 85224

Glendale

The Institute For Liver Health - Glendale, Glendale, Arizona, United States, 85306

Tucson

The Institute For Liver Health - Tucson, Tucson, Arizona, United States, 85711

Tucson

Adobe Gastroenterology, Tucson, Arizona, United States, 85712

North Little Rock

Arkansas Gastroenterology, North Little Rock, Arkansas, United States, 72117

Fresno

Fresno Clinical Research Center, Fresno, California, United States, 93720

Huntington Park

National Research Institute - Huntington Park, Huntington Park, California, United States, 90255

Los Angeles

Ruane Clinical Research Group, Los Angeles, California, United States, 90036

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 .
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Madrigal Pharmaceuticals, Inc.,

Rebecca Taub, MD, STUDY_DIRECTOR, Madrigal Pharmaceuticals, Inc.

Study Record Dates

2026-04