Evaluating the Pharmacokinetics and Safety of Miricorilant

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCorcept Therapeutics

About this trial

A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Miricorilant

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators