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)

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NCT04951219 · readout ≤ 224 d

Sponsored by Madrigal Pharmaceuticals, Inc. (industry) · MDGL — their whole pipeline →.

Phase

Phase 3

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Triple · Treatment

Enrollment

810actual

Sites

Countries

Puerto Rico, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-07-09

actual

When the study began enrolling

Primary completion

Mar 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Apr 2027

estimated

The whole study's end, after follow-up

First posted

2021-07-06

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-27

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

Non-Alcoholic Fatty Liver Disease

Intervention

Drug: Resmetirom — also filed as MGL-3196

Primary outcome

what the primary-completion date above is the date OF

The effect of once daily, oral administration of resmetirom on the incidence of adverse events.

measured 52 weeks

Publications

PMID 37786277 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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