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Thyroid Hormone Receptor Agonist

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients (MAESTRO-NAFLD1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Madrigal Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
Pivotal Trial

Summary

This trial tests an oral medication called resmetirom in patients with stable NASH cirrhosis. The goal is to see if it can safely reduce liver fat and improve liver health.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.
Secondary study objectives
The change from baseline to Week 52 in FibroScan vibration controlled transient elastography (kPa)
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo after 52 weeks on FibroScan controlled attenuation parameter (CAP)
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo on the percent change in apolipoprotein B (ApoB) from baseline to Week 24
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Open label: resmetiromExperimental Treatment1 Intervention
100 mg daily
Group II: Double blinded: resmetirom 80 mgExperimental Treatment1 Intervention
80 mg daily
Group III: Double blinded: resmetirom 100 mgExperimental Treatment1 Intervention
100 mg daily
Group IV: Double blinded: matching placeboPlacebo Group1 Intervention
Placebo daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MGL-3196
Not yet FDA approved

Find a Location

Who is running the clinical trial?

Madrigal Pharmaceuticals, Inc.Lead Sponsor
15 Previous Clinical Trials
4,034 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
2,971 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Rebecca Taub, MDStudy DirectorMadrigal Pharmaceuticals, Inc.
8 Previous Clinical Trials
3,288 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
2,759 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~224 spots leftby Dec 2025
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