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Resmetirom for Fatty Liver Disease (MAESTRO-NASH 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.
MAESTRO-NASH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowMAESTRO-NASH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.MAESTRO-NASH Trial Design
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Who is running the clinical trial?
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- You must be willing to participate in the study and provide written informed consent.I have been diagnosed with moderate to severe liver fibrosis due to NASH.I have been diagnosed with or suspected to have NASH.I have metabolic risk factors and my AST level is above 20 U/L.I am 18 years old or older.I have recently gained or lost a lot of weight.I have liver fibrosis confirmed by a test or biopsy.My liver biopsy confirms I have NASH with specific levels of scarring and inflammation.You have no steatosis.You have lobular inflammation (scored 0 to 3).I am 18 years old or older.I have been diagnosed with or suspected to have NASH.My AST levels are above 20 U/L and I have metabolic risk factors.
- Group 1: 100 mg MGL-3196
- Group 2: Matching Placebo
- Group 3: 80 mg MGL-3196
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Ruane Clinical Research: < 24 hours
- Tampa Bay Medical Research: < 48 hours
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