A Phase 3 interventional study of Resmetirom in Non-Alcoholic Fatty Liver Disease, sponsored by Madrigal Pharmaceuticals, Inc.. Active, not recruiting at 76 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Madrigal Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 810 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Madrigal Pharmaceuticals, Inc. is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results:
Exclusion Criteria:
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
Drug: Resmetirom
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
Drug: Resmetirom
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 up to an additional 66 months (ie, 52 weeks in MGL-3196-14 and up to 66 months in MGL-3196-18).
Drug: Resmetirom
For patients with NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 80 mg for up to 66 months.
Drug: Resmetirom
For patients without NASH cirrhosis who were screen failures from MGL-3196-11, open-label resmetirom 100 mg for 52 weeks
Drug: Resmetirom
For NASH cirrhosis patients who enter MGL-3196-18 directly or were screen failures from MGL-3196-19, open-label resmetirom 40 mg for up to 66 months.
Drug: Resmetirom
Tablet
Also known as: MGL-3196
The effect of once daily, oral administration of resmetirom on the incidence of adverse events.
Time frame: 52 weeks
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline
Time frame: 16 weeks
Percent change in the hepatic fat fraction as determined by MRI-PDFF from baseline
Time frame: 52 weeks
Percent change in LDL-C from baseline
Time frame: 28 weeks
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
Madrigal Pharmaceuticals, Inc.