A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
← catalyst calendarNCT03900429 · readout ≤ 529 d
Sponsored by Madrigal Pharmaceuticals, Inc. (industry) · MDGL — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
1,759actual
Sites
247
Countries
Australia, Austria, Belgium +13
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2019-03-28 | actual | When the study began enrolling |
| Primary completion | Jan 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2019-04-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- NASH - Nonalcoholic Steatohepatitis
Interventions
- Drug: MGL-3196 — also filed as Resmetirom
- Drug: Placebo
- Procedure: Liver Biopsy
Primary outcomes
what the primary-completion date above is the date OFWeek 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
measured 52 weeks
Month 54 Primary Objective: Time to experiencing an adjudicated Composite Clinical Outcome event (Final Primary Endpoint, at 54 months)
measured up to 54 months
Publications
- PMID 41895606 — linked by the registry
- PMID 41127972 — linked by the registry
- PMID 38324483 — linked by the registry
- PMID 37786277 — linked by the registry
- PMID 33860116 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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