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NCT04951219Phase 3ACTIVE NOT RECRUITING

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)

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 / Drugs
Resmetirom
View on ClinicalTrials.gov ↗
Sponsor
MDGL
Madrigal Pharmaceuticals
Liver Disease
C54/100
Study Details
Enrollment1000 participants
Primary Completion—
Lead SponsorMadrigal Pharmaceuticals, Inc.
Data Retrieved2026-04-11 04:20:54.370730+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Enrollment is complete. The trial is in its follow-up or data collection phase — a readout may occur on or near the primary completion date.

Enrolled: 1,000 participants
Sponsor Catalyst Profile

Madrigal Pharmaceuticals (MDGL) is the sponsoring company for this trial. BiotechSign currently grades this company C (54/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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