2026-07-06
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 116 → 141 locations
2026-05-29
minor
Study Status, Study Description, Study Design, Eligibility, Contacts/Locations v7
Enrollment target700→845
Study sites55→116
Eligibility criteria-543 characters
Inclusion Criteria:
Definitive (by histologic documentation) or probable NASH as causative agent for cirrhosis, following a modified version of the NASH Cirrhosis: Liver Forum Consensus Definitions for Clinical Trials.
a. Most recent biopsy (within last 5 years) shows cirrhosis with a NAS of ≥ 2, and at least two compo [...] A clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7) (Up to approximately 20%diagnosis of study patient population) c.
Historical biopsy (within last 5 years) shows steatosis.
Pathology report documents steatosis with no minimal percentag [...] [...]
Study description-11 characters
[...] linical Outcome events are defined as any of the following: liver-relatedall and CVcause mortality, liver transplant, and significant hepatic events [...]
2025-06-09
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 55 of 55 sites
2024-03-21
minor
Study Status, Study Description, Outcome Measures, Contacts/Locations v5
Primary completion date2025-08→2026-12
Completion date2025-11→2027-01
Study sites1→55
Study description+9 characters
[...] lly once daily in the morning for the duration of the study and (until the required number of Composite Clinical Outcome events are achieved).
Composite Clinical Outcome events are defined as any of the following: allliver-causerelated and CV mortality, liver transplant, and significant hepatic events [...]
2023-02-06
minor
Study Identification, Study Status v4
Study title+32 characters
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
Show 3 earlier versions
2022-10-18
minor
Study Status, Eligibility v3
Eligibility criteria+813 characters
[...] sis: Liver Forum Consensus Definitions for Clinical Trials.
NASHa. cirrhosis on mostMost recent biopsy (within last 5 years) whichshows cirrhosis with a NAS of ≥ 2, and at least two components: one being steatosis and at least one other component; OR NAS of ≥ 2, if steatosis = 0 or is estimatedungraded towith beinflammation approximatelyand/or ballooning, eligible with an MRI-PDFF >5%.
If steatosis and ballooning and/or steatosis and inflammation are noted by the local pathologist, then the biopsy qualifies even if a NAS is not provided (Approximately 70% of the study patient population) b.
hi [...] [...]
2022-09-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-08→confirmed 2022-08-26
Study sitesdetails revised at 1 of 1 site
2022-08-30
minor
Study Status, Arms and Interventions, Outcome Measures v1
InterventionsResmetirom (Drug)→Placebo (Drug), Resmetirom (Drug)
2022-08-11
minor
Original filing