Last month, Madrigal Pharmaceuticals (NSDQ:MDGL) announced promising preliminary results from an open-label Phase 3 trial from its MAESTRO-NAFLD-1 study focused on Resmetirom.
The drug, also known as MGL-3196, appeared to support reducing fat and fibrosis within the liver while also curbing biomarkers associated with inflammation. The data also suggest that the drug reduces LDL cholesterol.
Now, the company has announced a new trial known as MAESTRO-NAFLD-OLE, an open-label active treatment extension study of MAESTRO-NAFLD-1.
The new trial will enable patients who complete MAESTRO-NAFLD-1 to receive resmetirom for 52 additional weeks. Both placebo and previous resmetirom recipients will be eligible to participate.
The MAESTRO-NAFLD-1 study, which involves approximately 1,200 patients, is slated for completion before the end of 2021.
Lancet published positive data from a Phase 2 trial involving resmetirom in 2019.
Madrigal believes that Resmetirom is a first-in-class small-molecule thyroid hormone receptor, a beta-selective agonist.
Filed Under: clinical trials, Drug Discovery