Madrigal pharmaceuticals announces first patient dosed in maestro-nafld-1, a second phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom (mgl-3196) in patients with non-alcoholic steatohepatitis (nash) and presumed nash (
-- maestro-nafld-1 is the second resmetirom phase 3 clinical trial in patients with nash and presumed nash and follows maestro-nash, a phase 3 multi-center, double-blind, randomized, placebo-controlled study in patients with non-alcoholic steatohepatitis (nash) and fibrosis, that was initiated in march 2019 -- conshohocken, pa., dec. 18, 2019 (globe newswire) -- madrigal pharmaceuticals, inc. (nasdaq:mdgl) announced today that it has dosed the first patient in its second phase 3 clinical trial, maestro-nafld-1 with its first-in-class, once daily, oral thyroid hormone receptor-beta selective agonist, resmetirom (mgl-3196). madrigal initiated its first phase 3 clinical program, maestro-nash, in nash patients with advanced liver fibrosis (stages f2 and f3) in march 2019. the primary endpoint for that trial, after one year of treatment, is resolution of nash; key secondary endpoints include ldl-cholesterol lowering and reduction in liver fibrosis. additionally, clinical benefit in reducing progression to more advanced liver disease, including cirrhosis, is a long-term goal of maestro-nash. [ clinicaltrials.gov/nct03900429 ]
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