Clinical Quiz: MAESTRO-NASH Trial Procedures for Resmetirom in MASH

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Key Takeaways

Resmetirom (Rezdiffra) received FDA accelerated approval for MASH with moderate to advanced fibrosis, a first for this liver disease.
The approval was based on 18 clinical studies, including 12 phase 1, two phase 2, and four phase 3 studies.
MAESTRO-NASH, a phase 3 double-blind, randomized, placebo-controlled trial, is crucial in resmetirom's clinical development program.

Test your knowledge of the phase 3 MAESTRO-NASH trial supporting resmetirom (Rezdiffra)’s FDA accelerated approval for MASH with this quiz.

HCPLive Clinical Quiz

On March 14, 2024, the US Food and Drug Administration granted accelerated approval to resmetirom (Rezdiffra) for noncirrhotic nonalcoholic steatohepatitis (NASH), now known as metabolic dysfunction-associated steatohepatitis (MASH), with moderate to advanced fibrosis, making it the first and only treatment to receive approval for the progressive liver disease.

The decision followed 18 clinical studies in the oral, thyroid hormone receptor (THR)-β selective agonist’s clinical development program: 12 phase 1 studies, a pair of phase 2 studies, and 4 phase 3 studies. MAESTRO-NASH is an ongoing phase 3, double-blind, randomized, placebo-controlled trial, and is 1 of 4 phase 3 studies in resmetirom’s clinical development program supporting its approval in adult patients with NASH and fibrosis.

Test your knowledge of MAESTRO-NASH with this clinical quiz!

What is the planned duration of the MAESTRO-NASH trial?

Check out our other MAESTRO-NASH quiz: Clinical Quiz: MAESTRO-NASH Trial Participants, Endpoints for Resmetirom in MASH

References

^{Brooks, A. Resmetirom (Rezdiffra) Receives Historic FDA Approval for Noncirrhotic NASH. HCPLive. March 14, 2024. Accessed September 20, 2024. https://www.hcplive.com/view/resmetirom-rezdiffra-receives-historic-fda-approval-for-noncirrhotic-nash}
^{Harrison SA, Bedossa P, Guy CD, et al. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Eng J Med. doi:10.1056/NEJMoa2309000}