News

Article

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

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.
SHOW MORE

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

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

  1. 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
  2. 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
Related Videos
Marcelo Kugelmas, MD | Credit: South Denver Gastroenterology
John Tesser, MD, Adjunct Assistant Professor of Medicine, Midwestern University, and Arizona College of Osteopathic Medicine, and Lecturer, University of Arizona Health Sciences Center, and Arizona Arthritis & Rheumatology Associates
Brigit Vogel, MD: Exploring Geographical Disparities in PAD Care Across US| Image Credit: LinkedIn
Eric Lawitz, MD | Credit: UT Health San Antonio
| Image Credit: X
Ahmad Masri, MD, MS | Credit: Oregon Health and Science University
Ahmad Masri, MD, MS | Credit: Oregon Health and Science University
Stephen Nicholls, MBBS, PhD | Credit: Monash University
Marianna Fontana, MD, PhD: Nex-Z Shows Promise in ATTR-CM Phase 1 Trial | Image Credit: Radcliffe Cardiology
Zerlasiran Achieves Durable Lp(a) Reductions at 60 Weeks, with Stephen J. Nicholls, MD, PhD | Image Credit: Monash University
© 2024 MJH Life Sciences

All rights reserved.