A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR
NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR
NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3
MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.
Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.
Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.
Women who are pregnant, planning to become pregnant, or lactating.
BMI < 18 kg/m² or > 45 kg/m².
Single group
Miricorilant
Drug100 mg administered orally, once daily
Change in fasting hepatic lipogenesis after 6 weeks of treatment
Change in peak lipogenesis after 6 weeks of treatment.
Change in liver fat content by MRI-PDFF after 6 weeks of treatment
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Corcept Therapeutics
Lead sponsor
University of Missouri-Columbia
Collaborator
