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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)

NCT04951219 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2025-08-03

No results posted yet for this study

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)

Conditions

  • Non-Alcoholic Fatty Liver Disease

Interventions

DRUG

Resmetirom

Tablet

Sponsors & Collaborators

  • Madrigal Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Rebecca Taub, MD · Madrigal Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2026-03-31
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04951219 on ClinicalTrials.gov