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Thyroid Hormone Receptor Agonist

Resmetirom for Fatty Liver Disease (MAESTRO-NASH Trial)

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
Must be willing to participate in the study and provide written informed consent.
Suspected or confirmed diagnosis of NASH
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 54 months
Awards & highlights
Pivotal Trial

MAESTRO-NASH Trial Summary

This trial will test whether the drug MGL-3196 can help treat NASH and prevent it from progressing to more serious liver diseases.

Who is the study for?
Adults over 18 with suspected or confirmed NASH and liver fibrosis stages 1A to 3 are eligible for this trial. They must have metabolic risk factors, an AST level above 20 U/L, and evidence of increased liver fat via MRI-PDFF or a biopsy showing NASH within the last 24 weeks. Participants should not have had significant weight changes recently.Check my eligibility
What is being tested?
The study is testing if MGL-3196 (Resmetirom) at doses of either 80 mg or 100 mg is more effective than a placebo in resolving NASH, reducing liver fibrosis on biopsies, and preventing progression to cirrhosis or advanced liver disease.See study design
What are the potential side effects?
While specific side effects for MGL-3196 (Resmetirom) aren't listed here, common side effects may include gastrointestinal issues, fatigue, headache, potential liver-related symptoms due to the nature of the drug's target organ.

MAESTRO-NASH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with or suspected to have NASH.
Select...
My AST levels are above 20 U/L and I have metabolic risk factors.
Select...
I have been diagnosed with moderate to severe liver fibrosis due to NASH.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with or suspected to have NASH.
Select...
I have metabolic risk factors and my AST level is above 20 U/L.
Select...
I have liver fibrosis confirmed by a test or biopsy.
Select...
My liver biopsy confirms I have NASH with specific levels of scarring and inflammation.

MAESTRO-NASH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 54 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 54 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Month 54 Primary Objective: Time to experiencing an adjudicated Composite Clinical Outcome event (Final Primary Endpoint, at 54 months)
Week 52 Dual Primary Objectives: To determine the effect of 80 or 100 mg MGL-3196 vs matching placebo on liver biopsy (NASH CRN score) at Week 52 compared with Baseline
Secondary outcome measures
LDL Cholesterol Lipoproteins
Other outcome measures
To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with Stage 1 fibrosis

Awards & Highlights

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

MAESTRO-NASH Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: 100 mg MGL-3196Active Control1 Intervention
100 mg daily
Group II: 80 mg MGL-3196Active Control1 Intervention
80 mg daily
Group III: Matching PlaceboPlacebo Group1 Intervention
Placebo Daily

Find a Location

Who is running the clinical trial?

Madrigal Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
3,590 Total Patients Enrolled
4 Trials studying Non-alcoholic Fatty Liver Disease
2,555 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Rebecca Taub, MDStudy DirectorMadrigal Pharmaceuticals, Inc.
8 Previous Clinical Trials
2,872 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
2,343 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

MGL-3196 (Resmetirom) (Thyroid Hormone Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03900429 — Phase 3
Non-alcoholic Fatty Liver Disease Research Study Groups: 100 mg MGL-3196, Matching Placebo, 80 mg MGL-3196
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: MGL-3196 (Resmetirom) Highlights & Side Effects. Trial Name: NCT03900429 — Phase 3
MGL-3196 (Resmetirom) (Thyroid Hormone Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900429 — Phase 3
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT03900429 — Phase 3

Frequently Asked Questions

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

Will this study be the first to collect this type of data?

"MGL-3196 has been researched since 2019, with the first Phase 3 study taking place that year and sponsored by Madrigal Pharmaceuticals, Inc. 100 mg MGL-3196 was approved for use following that first study in 2000. Currently, there are 3 active studies being conducted in 143 different cities spanning 15 countries."

Answered by AI

Is this clinical trial taking place at a considerable number of locations across the United States?

"This study is being conducted at 86 different research sites. While most are based in New york, Fort Worth and Bethesda, there are also 86 other locations around the country. If you enroll in the clinical trial, it would be best to choose the location nearest you to minimize travel."

Answered by AI

Are there any risks associated with MGL-3196 at a dosage of 100 mg?

"There is some efficacy data and multiple rounds of safety data, both of which support the safety of MGL-3196 at a dosage of 100 mg."

Answered by AI

How large is the cohort for this clinical trial?

"In order to move forward, this clinical study requires 2000 willing and eligible participants. The specified inclusion criteria must be met in order to take part in this research. Patients can inquire about participating at various medical facilities, such as Mt. Sinai Medical Center in New york, New York and Texas Digestive Disease Consultants - Fort Worth in Fort Worth, Maryland."

Answered by AI

Are there many precedents for using 100 mg MGL-3196 for research?

"There are currently 3 active trials in Phase 3 testing the efficacy of 100 mg MGL-3196. Out of the 371 total locations, several of the trials for 100 mg MGL-3196 are based in Rollingwood, Texas."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Illinois
Tennessee
Other
How old are they?
18 - 65
What site did they apply to?
Ochsner Medical Center
Saint Louis University
Tampa Bay Medical Research
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

releif and money for study. I eas just diagnosed with a fatty liver. To see if proposed treatment would be effective for NASH.
PatientReceived 1 prior treatment
My father, uncle and grandmother died of liver cancer and I have Fibrosis 1.
PatientReceived 2+ prior treatments
I would like to get rid of my Fatty Liver and be able to live with a healthy liver.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

I am a retired military member and current patient at BAMC, does that help?
PatientReceived 1 prior treatment

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. Ruane Clinical Research: < 24 hours
  2. Tampa Bay Medical Research: < 48 hours
~338 spots leftby Feb 2025