Resmetirom for Fatty Liver Disease

(MAESTRO-NASH Trial)

Recruiting in Palo Alto (17 mi)

+245 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Madrigal Pharmaceuticals, Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Rebecca Taub, MD

Principal Investigator

Madrigal Pharmaceuticals, Inc.

Eligibility Criteria

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.

Inclusion Criteria

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.

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

Exclusion Criteria

I have recently gained or lost a lot of weight.

Treatment Details

Interventions

• MGL-3196 (Resmetirom) (Thyroid Hormone Receptor Agonist)
• Placebo (Other)

Trial Overview 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.

Participant Groups

Group I: 100 mg MGL-3196 Active Control 2 Interventions

100 mg daily

Group II: 80 mg MGL-3196 Active Control 2 Interventions

80 mg daily

Group III: Matching Placebo Placebo Group 2 Interventions

Placebo Daily

Who Is Running the Clinical Trial?

Madrigal Pharmaceuticals, Inc.

Lead Sponsor

Trials

16

Recruited

5,400+