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Thyroid Hormone Receptor Agonist

Resmetirom for Non-alcoholic Fatty Liver Disease

Phase 3
Recruiting
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

Study Summary

This trial is testing a new drug, resmetirom, to see if it is safe and tolerated when taken once daily. The trial will last 52 weeks.

Who is the study for?
This trial is for patients with a specific liver condition called Non-alcoholic Fatty Liver Disease (NAFLD) who have already completed the MAESTRO-NAFLD-1 study. They must have certain levels of liver scarring and inflammation but cannot have severe liver conditions like cancer, significant alcohol use in the past year, autoimmune diseases, or other health issues that could affect their participation.Check my eligibility
What is being tested?
The trial is testing Resmetirom taken orally once daily for 52 weeks to see how safe it is and what its effects are on biomarkers in patients with NAFLD. It's an open-label extension which means everyone gets the active drug and knows what they're taking.See study design
What are the potential side effects?
While specific side effects of Resmetirom aren't listed here, common ones for drugs treating NAFLD may include gastrointestinal symptoms like nausea or diarrhea, headaches, fatigue, potential liver-related issues, and possibly allergic reactions.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The effect of once daily, oral administration of resmetirom on the incidence of adverse events.
Secondary outcome measures
Percent change in LDL-C from baseline
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline

Trial Design

6Treatment groups
Experimental Treatment
Group I: Open-labelExperimental Treatment1 Intervention
For patients assigned to open-label treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, open-label resmetirom at same dose as MGL-3196-14 for an additional 52 weeks. NASH cirrhosis patients may receive open-label resmetirom for an additional 52 weeks (ie, 52 weeks in MGL-3196-14 and 104 weeks in MGL-3196-18).
Group II: Open-Label 80 mgExperimental Treatment1 Intervention
For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for 104 weeks
Group III: Open-Label 40 mgExperimental Treatment1 Intervention
For NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for 104 weeks
Group IV: Open Label 100 mgExperimental Treatment1 Intervention
For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks
Group V: Double-blind 80 mg DailyExperimental Treatment1 Intervention
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 80 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
Group VI: Double-blind 100 mg DailyExperimental Treatment1 Intervention
For patients assigned to double-blind treatment and who completed Week 52 and 56 of MAESTRO-NAFLD-1, double-blind resmetirom 100 mg for first 12 weeks followed by open-label resmetirom 100 mg for weeks 12-52
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
14 Previous Clinical Trials
4,590 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
3,555 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Rebecca Taub, MDStudy DirectorMadrigal Pharmaceuticals, Inc.
8 Previous Clinical Trials
3,872 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
3,343 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Non-alcoholic Fatty Liver Disease Research Study Groups: Open Label 100 mg, Double-blind 80 mg Daily, Double-blind 100 mg Daily, Open-label, Open-Label 40 mg, Open-Label 80 mg

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still enrolling participants for this clinical trial?

"The study, which was originally posted on 7/9/2021, as indicated by clinicaltrials.gov, is still recruiting participants."

Answered by AI

Has the Food and Drug Administration cleared Resmetirom for patient use?

"Resmetirom's safety is estimated to be a 3 because it is a Phase 3 trial. This indicates that, while there is some data supporting efficacy, multiple rounds of data have been collected to support Resmetirom's safety."

Answered by AI

In how many different medical settings is this clinical trial being conducted?

"69 patients have enrolled in this clinical trial at various locations, such as Liver Institute Northwest in Seattle, Northwestern Memorial Physicians Group in Chicago, and Diabetes and Endocrinology Consultants in Morehead City."

Answered by AI

What else do we know about Resmetirom from other research?

"Currently, there are three ongoing studies of Resmetirom's efficacy in Phase 3 trials. Although most research on Resmetirom is conducted in Bruxelles and Brussels, medical centres in 371 locations across the world are running clinical trials for the drug."

Answered by AI

How many people are a part of this research project?

"That is correct, the trial is currently looking for 1000 participants from 69 different locations. The original posting was on July 9th, 2021 and there have been edits as recent as October 18th, 2022."

Answered by AI

What other similar research projects have been undertaken?

"Research for Resmetirom began in 2019 when Madrigal Pharmaceuticals, Inc. sponsored an initial clinical trial. Since the first Phase 3 study was completed with a sample size of 2000 people, the drug has received approval and is currently being studied in 143 cities across 15 countries."

Answered by AI

Who else is applying?

What state do they live in?
California
Illinois
Texas
Other
How old are they?
18 - 65
What site did they apply to?
The Villages Research Center
National Research Institute - Los Angeles
Northwestern Memorial Physicians Group
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0

What questions have other patients asked about this trial?

Is this a paid trial? More indepth details needed. How much travel is involved?
PatientReceived no prior treatments

Why did patients apply to this trial?

Cuz of the money. To see if I have Fatty liver. General concern based on one symptom.
PatientReceived 2+ prior treatments
I want to help science create treatments. Doctors have done nothing about my fatty liver.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
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)
2021. "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)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04951219.
All > Nafld
~400 spots leftby Mar 2026
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