Corcept Initiates MONARCH – A Phase 2b Trial in Non-Alcoholic Steatohepatitis (NASH)
Excerpt from the Press Release:
MENLO PARK, Calif., Oct. 26, 2023 (GLOBE NEWSWIRE) — Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncology, metabolism, and neurology disorders by modulating the effects of the hormone cortisol, today announced it has initiated MONARCH, a Phase 2b trial of its proprietary selective cortisol modulator miricorilant in patients with non-alcoholic steatohepatitis (NASH).
MONARCH is a 150-patient, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of miricorilant in adult patients with biopsy-confirmed NASH. Patients will receive either 100 mg of miricorilant or placebo orally twice weekly for 48 weeks. The primary endpoint is reduction in liver fat, with NASH resolution and fibrosis improvement as key secondary endpoints.
“We are excited to initiate the MONARCH study and to build on the promising results of our Phase 1b study, which demonstrated that miricorilant effectively reduces liver fat, improves liver health and key metabolic and lipid measures and is well-tolerated. Miricorilant has the potential to greatly benefit the millions of patients with NASH. We look forward to sharing more details about MONARCH at the upcoming AASLD conference,” says Bill Guyer, PharmD, Corcept’s Chief Development Officer.
About NASH
Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD) that afflicts millions of patients and is a leading cause of liver-related mortality. Cortisol modulation may serve as a treatment for NASH since cortisol activity at the glucocorticoid receptor and mineralocorticoid receptor has been implicated in the development and progression of NAFLD. There are no current medications approved to treat NASH.
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