What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include thyroid hormone receptor-beta agonists like MGL-3196, statins, and GLP-1 receptor agonists. Thyroid hormone receptor-beta agonists may cause side effects such as increased heart rate and potential liver enzyme elevations. Statins are generally well-tolerated but can cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. GLP-1 receptor agonists, such as liraglutide and semaglutide, often cause gastrointestinal symptoms like nausea and vomiting, and in rare cases, may lead to pancreatitis or thyroid cancer. Lifestyle modifications, including diet and exercise, are essential but typically do not have adverse side effects.

What prior FDA approvals exist?

As of now, there are no FDA-approved treatments specifically for Non-alcoholic Fatty Liver Disease (NAFLD). However, several drugs are under investigation, including MGL-3196 (Resmetirom), a Thyroid Hormone Receptor-Beta Agonist, which is being studied for its potential to resolve NASH (Non-alcoholic Steatohepatitis) and reduce liver fibrosis. Other investigational treatments for NAFLD and NASH include GLP-1 receptor agonists like liraglutide and semaglutide, which have shown promise in improving liver histology and metabolic parameters in clinical trials.

What other types of research exist?

Promising alternatives to MGL-3196 for NAFLD patients include Cilofexor, a nonsteroidal FXR agonist, which has shown efficacy in a phase 2 trial, and GLP-1 receptor agonists like AC3174, which have demonstrated improvements in metabolic, biochemical, and histopathological indices of NASH in preclinical studies. Additionally, the β3 adrenergic receptor agonist BRL37344 has shown benefits in reducing liver fat accumulation and inflammation in a rat model of NAFLD.

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Thyroid Hormone Receptor Agonist

Resmetirom for Fatty Liver Disease (MAESTRO-NASH 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

Must be willing to participate in the study and provide written informed consent.

Male and female adults ≥ 18 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 54 months

Awards & highlights

Pivotal Trial

Summary

This trial is testing a medication called MGL-3196 to see if it can help treat patients with NASH and liver fibrosis. The medication works by reducing fat and inflammation in the liver, which can help heal and protect it from further damage.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with or suspected to have NASH.

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I have metabolic risk factors and my AST level is above 20 U/L.

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I have liver fibrosis confirmed by a test or biopsy.

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My liver biopsy confirms I have NASH with specific levels of scarring and inflammation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 54 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

LDL Cholesterol Lipoproteins

Other study objectives

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.

Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: 100 mg MGL-3196Active Control2 Interventions

100 mg daily

Group II: 80 mg MGL-3196Active Control2 Interventions

80 mg daily

Group III: Matching PlaceboPlacebo Group2 Interventions

Placebo Daily

0 / 6Eligibility 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

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include thyroid hormone receptor-beta agonists like MGL-3196 (Resmetirom), which target lipid metabolism in the liver. These agonists work by stimulating the thyroid hormone receptor-beta, leading to increased oxidation of fatty acids and reduced lipogenesis, thereby decreasing liver fat content. This mechanism is crucial for NAFLD patients as it directly addresses the accumulation of fat in the liver, which is a hallmark of the disease. Other treatments, such as GLP-1 receptor agonists and SGLT2 inhibitors, also play roles in improving liver parameters by enhancing insulin sensitivity and reducing inflammation. These treatments are significant as they help mitigate the progression of NAFLD to more severe liver conditions like fibrosis and cirrhosis.

The GPR40 Full Agonist SCO-267 Improves Liver Parameters in a Mouse Model of Nonalcoholic Fatty Liver Disease without Affecting Glucose or Body Weight.