RecruitingNonalcoholic Steatohepatitis (NASH)Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated CirrhosisMetabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
Evaluating the Pharmacokinetics and Safety of Miricorilant
Eligible age
18–75 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Sponsor: Corcept Therapeutics
You may qualify if…
- ✓ Evidence of presumed MASH with either FibroScan liver stiffness measurement ≥ 8 kPa and controlled attenuation parameter (CAP) ≥ 280 dB/m OR historical biopsy within 12 months of screening that meets the following criteria:
- ✓ 1. 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
- ✓ 2. 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.
- ✓ Presence of at least 1 of the following metabolic conditions that increase the risk of MASH:
- ✓ 1. Diagnosis of type 2 diabetes OR
- ✓ 2. Presence of 2 or more components of metabolic syndrome:
- ✓ Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose
You may not qualify if…
- ✕ 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.
- ✕ Have type 1 diabetes.
- ✕ Have poorly controlled type 2 diabetes with a glycated hemoglobin (HbA1c)
- ✕ 9.5%.
- ✕ Have any other chronic liver disease
Where it's recruiting
Texas
San Antonio
Source: ClinicalTrials.gov · NCT07553663 · last updated 2026-05-26