What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD), such as selective thyroid hormone receptor-beta agonists like Resmetirom, often have side effects including fatigue, headache, and nausea. Other treatments for NAFLD, such as weight loss medications and lifestyle interventions, may also cause gastrointestinal issues, such as diarrhea and abdominal pain. Additionally, some pharmacologic treatments can lead to elevated liver enzymes and potential liver injury. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Non-alcoholic Fatty Liver Disease (NAFLD). Resmetirom, a selective thyroid hormone receptor-beta agonist, is currently under investigation in clinical trials for its potential benefits in treating NAFLD. Other investigational drugs for NAFLD include various agents targeting metabolic pathways, inflammation, and fibrosis, but none have yet received FDA approval.

What other types of research exist?

Promising novel alternatives to Resmetirom for NAFLD patients include: 1) Semaglutide, a GLP-1 receptor agonist, which has shown significant improvement in liver histology and weight loss in clinical trials. 2) Lanifibranor, a pan-PPAR agonist, which has demonstrated efficacy in reducing liver fibrosis and inflammation. 3) Aramchol, a stearoyl-CoA desaturase-1 (SCD1) modulator, which has shown potential in reducing liver fat content and improving liver function. These alternatives are in various stages of clinical development and have shown promising results in recent studies.

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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

Must not have

Chronic liver diseases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying the safety and tolerability of Resmetirom, a pill taken regularly. It involves patients who are already using this medication. Resmetirom helps manage certain health conditions by targeting specific parts of the body and has shown to reduce liver fat in patients with non-alcoholic steatohepatitis (NASH) in previous studies.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a long-term liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective thyroid hormone receptor-beta agonists, such as Resmetirom, work by specifically targeting the thyroid hormone receptor-beta in the liver, which helps to reduce liver fat, inflammation, and fibrosis without affecting the heart. This is crucial for NAFLD patients as it directly addresses the underlying metabolic dysfunctions that contribute to the disease. Other common treatments include lifestyle modifications like diet and exercise, which improve insulin sensitivity and reduce liver fat. Medications such as pioglitazone and GLP-1 receptor agonists also help by improving insulin resistance and reducing liver inflammation. These treatments are important as they aim to halt or reverse the progression of NAFLD, thereby preventing complications like cirrhosis and liver cancer.