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Thyroid Hormone Receptor Agonist

Resmetirom for Non-alcoholic Fatty Liver Disease (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

MAESTRO-NAFLD1 Trial Summary

This trial will study the safety and tolerability of a new drug, resmetirom, compared to a placebo. One hundred patients will be enrolled, and the trial will include a special safety population of patients with a specific liver condition.

Eligible Conditions

Non-alcoholic Fatty Liver Disease

MAESTRO-NAFLD1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

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 80 or 100 mg resmetirom versus placebo on the incidence of adverse events.

Secondary outcome measures

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

MAESTRO-NAFLD1 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Madrigal Pharmaceuticals, Inc.Lead Sponsor

14 Previous Clinical Trials

4,247 Total Patients Enrolled

4 Trials studying Non-alcoholic Fatty Liver Disease

3,212 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Rebecca Taub, MDStudy DirectorMadrigal Pharmaceuticals, Inc.

8 Previous Clinical Trials

3,529 Total Patients Enrolled

2 Trials studying Non-alcoholic Fatty Liver Disease

3,000 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Frequently Asked Questions

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

How large is the sample size for this clinical trial?

"Unfortunately, this particular study is not recruiting patients at the moment. The trial was first posted on December 16th, 2019 and updated last on August 31st, 2022. For individuals who are interested in other studies, there are presently 384 clinical trials actively searching for patients with nonalcoholic steatohepatitis and 3 trials for Resmetirom admitting patients."

Answered by AI

What is the present legal status of Resmetirom in the United States?

"Since Resmetirom is a Phase 3 trial drug, there are both multiple rounds of safety data as well as some efficacy data, which our team has rated a 3 in terms of risk."

Answered by AI

Is this research still enrolling participants?

"As of right now, this trial is not looking for any more patients. The initial posting was on December 16th 2019 and the most recent update was on August 31st 2022. However, there are other active trials that might be of interest. In particular, there are 384 clinical trials related to nonalcoholic steatohepatitis and 3 Resmetirom studies recruiting participants."

Answered by AI

Are there any Resmetirom case studies that have been published?

"Resmetirom was first introduced in 2019 at Hôpital Erasme. Out of the 18295 completed clinical trials, 3 are currently ongoing; a significant proportion of these taking place in Ypsilanti, Michigan."

Answered by AI

In how many different venues is this experiment being conducted today?

"Huron Gastroenterology, the San Fernando Valley Health Institute, and Bon Secours Liver Institute of Richmond are a few of the 78 medical facilities enrolling patients for this study."

Answered by AI

Has this type of research been done before?

"3 clinical trials for Resmetirom are currently underway in 143 cities and 15 countries. The first study was sponsored by Madrigal Pharmaceuticals, Inc. in 2019. That year, 2000 patients completed the Phase 3 drug approval stage of the trial. As of now, a total of 18295 studies have been conducted since 2019."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04197479.