A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
← catalyst calendarNCT05500222 · readout ≤ 134 d
Sponsored by Madrigal Pharmaceuticals, Inc. (industry) · MDGL — their whole pipeline →.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
845estimated
Sites
141
Countries
Belgium, Canada, France +6
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 | 2022-08-26 | actual | When the study began enrolling |
| Primary completion | Dec 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-08 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- NASH
- Cirrhosis, Liver
Interventions
- Drug: Resmetirom — also filed as MGL-3196
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFIncidence Of adjudicated Composite Clinical Outcome event
measured Baseline up to Month 36
Publications
- PMID 37786277 — 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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