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NCT05500222Phase 3ACTIVE NOT RECRUITING

A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)

Study Summary

This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.

Conditions
NASHCirrhosis, Liver
Interventions / Drugs
ResmetiromPlacebo
View on ClinicalTrials.gov ↗
Sponsor
MDGL
Madrigal Pharmaceuticals
Liver Disease
C54/100
Study Details
Enrollment700 participants
Primary Completion—
Lead SponsorMadrigal Pharmaceuticals, Inc.
Data Retrieved2026-04-11 04:20:54.370740+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: 700 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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