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Thyroid Hormone Receptor Agonist

Resmetirom for NASH Cirrhosis

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
Definitive (by histologic documentation) or probable NASH as causative agent for cirrhosis, following a modified version of the NASH Cirrhosis: Liver Forum Consensus Definitions for Clinical Trials.
a. Most recent biopsy (within last 5 years) shows cirrhosis with a NAS of ≥ 2, and at least two components: one being steatosis and at least one other component; OR NAS of ≥ 2, if steatosis = 0 or is ungraded with inflammation and/or ballooning, eligible with an MRI-PDFF >5%. If steatosis and ballooning and/or steatosis and inflammation are noted by the local pathologist, then the biopsy qualifies even if a NAS is not provided (Approximately 70% of the study patient population)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to month 36
Awards & highlights

Study Summary

This trial will study the effects of a new medication on participants with well-compensated NASH cirrhosis.

Who is the study for?
This trial is for adults with well-compensated NASH cirrhosis, confirmed by biopsy or MRI-PDFF. They should have a Child-Pugh A score and no history of hepatic decompensation. Participants must not have other chronic liver diseases or a MELD score ≥12.Check my eligibility
What is being tested?
The study tests if taking Resmetirom (80 mg daily) affects the time until patients with NASH cirrhosis experience significant health events compared to a placebo group. It's an oral medication given once per day.See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with treatments for liver conditions may include gastrointestinal issues, fatigue, headache, itching, and potential changes in liver enzymes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cirrhosis is caused by NASH, confirmed through tests.
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My latest liver biopsy shows significant damage and fat.
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I have a history of NASH with significant fibrosis, now with cirrhosis.
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I have a history of fatty liver disease, now with cirrhosis, and I am obese or have type 2 diabetes.
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My liver disease is stable with a low risk score and no history of severe liver failure.
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My recent MRI shows stable fat levels without significant weight change.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence Of adjudicated Composite Clinical Outcome event

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ResmetiromActive Control1 Intervention
80 mg daily
Group II: PlaceboPlacebo Group2 Interventions
matching placebo daily

Find a Location

Who is running the clinical trial?

Madrigal Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
4,890 Total Patients Enrolled
Thomas HareStudy DirectorVP, Clinical Research

Media Library

Resmetirom (Thyroid Hormone Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05500222 — Phase 3
Nonalcoholic Steatohepatitis Research Study Groups: Resmetirom, Placebo
Nonalcoholic Steatohepatitis Clinical Trial 2023: Resmetirom Highlights & Side Effects. Trial Name: NCT05500222 — Phase 3
Resmetirom (Thyroid Hormone Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05500222 — Phase 3
Nonalcoholic Steatohepatitis Patient Testimony for trial: Trial Name: NCT05500222 — Phase 3

Frequently Asked Questions

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

Could you please remind me of the dangers of Resmetirom?

"Resmetirom has undergone Phase 3 trials, meaning that not only is there some evidence of efficacy, but also that there is extensive safety data. Consequently, our team rated Resmetirom's safety as a 3."

Answered by AI

Are patients being sought for this clinical trial at this time?

"The study, which is recruiting patients as indicated by the clinicaltrials.gov website, was first posted on 8/26/2022 and was last updated on 10/18/2022."

Answered by AI

How many people fit the screening criteria for this experiment?

"That is correct. The clinical trial is currently recruiting and was posted on 8/26/2022. The last update was on 10/18/2022. They are enrolling 700 participants from 1 location."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Arkansas Gastroenterology
Florida Medical Clinic
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have only taken supplements for my NASH and liver Fibrosis and no medicine for liver yet. I want to have the clinical trial of the drug resmetirom.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long to take resmetirom?
PatientReceived 2+ prior treatments
~425 spots leftby Dec 2026