MAESTRO-NASH (resmetirom 100 mg)
Trial question
What is the role of resmetirom in patients with MASH and liver fibrosis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 644
644 patients (360 female, 284 male).
Inclusion criteria: adult patients with MASH and liver fibrosis.
Key exclusion criteria: alcohol consumption > 20 g/day for women and > 30 g/day for men; glycated hemoglobin level > 9.0% at screening; causes of chronic liver disease other than noncirrhotic MASH.
Interventions
N=323 resmetirom (at a dose of 100 mg once daily).
N=321 placebo (matching placebo once daily).
Primary outcome
Metabolic dysfunction-associated steatohepatitis resolution with no worsening fibrosis
29.9%
9.7%
29.9 %
22.4 %
14.9 %
7.5 %
0.0 %
Resmetirom
Placebo
Significant
increase ▲
NNT = 4
Significant increase in MASH resolution with no worsening fibrosis (29.9% vs. 9.7%; AD 20.7%, 95% CI 15.3 to 26.2).
Secondary outcomes
Significant increase in fibrosis improvement by ≥ 1 stage with no worsening of NAFLD activity score (25.9% vs. 14.2%; AD 11.8%, 95% CI 6.4 to 17.2).
Significantly greater reduction in low density lipoprotein cholesterol level at week 24 (16.3% vs. -0.1%; AD 16.4%, 95% CI 12.6 to 20.1).
Significantly greater reduction in ApoB level at week 24 (19.8% vs. -0.39%; AD 20.2%, 95% CI 17.4 to 22.9).
Safety outcomes
No significant difference in adverse and serious adverse events.
Conclusion
In adult patients with MASH and liver fibrosis, resmetirom was superior to placebo with respect to MASH resolution with no worsening fibrosis.
Reference
Stephen A Harrison, Pierre Bedossa, Cynthia D Guy et al. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509.
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