A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Nonalcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 3 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis score of F1 OR
NAS ≥ 2 with at least ≥ 1 point in any two subcomponents of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F2 or 3.
Aspartate aminotransferase (AST) > 17 U/L for women and AST > 20 U/L for men. The AST inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of Screening.
Diagnosis of type 2 diabetes OR
Women who are pregnant, planning to become pregnant, or are lactating.
Have a BMI < 18 kg/m2 or > 45 kg/m2.
Have significant alcohol consumption of more than 20 g per day for women and 30 g per day for men within 1 year prior to screening or score of ≥8 on AUDIT questionnaire
Have had liver transplantation or plan to have liver transplantation during the study.
Single group
Miricorilant
DrugSingle dose of 60 mg miricorilant
Assessment of miricorilant PK parameters
Time to maximum concentration (Tmax)
Assessment of miricorilant PK parameters
Maximum concentration over the dosing interval (Cmax)
Assessment of miricorilant PK parameters
Concentration at 24 hours post-dose (C24)
Assessment of miricorilant PK parameters
Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC(0-last))
Incidence of adverse events (AEs), serious adverse events (SAEs), clinical laboratory evaluations, (hematology, clinical chemistry, urinalysis), 12-lead electrocardiograms (ECGs), vital sign measurements and physical examinations.
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