Evaluation of Miricorilant on Liver Fat in Patients With MASLD

Eligibility Criteria

• * Evidence of liver fibrosis with either FibroScan liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 dB/m OR historical biopsy within 12 months of screening that meets the following criteria:
• 1. NAFLD Activity Score (NAS) ≥ 3 with ≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F1 OR
• 2. NAS ≥ 2 with ≥ 1 point in subcomponent of steatosis and ≥ 1 point in subcomponent of ballooning or inflammation, and a NASH CRN fibrosis score of F2 or 3
• * 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.
• * FIB-4 score of ≥ 1.3. The FIB-4 inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening.
• * MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.
• * Have a stable weight within the last 6 months, defined by no more than a 5% loss of initial body weight.
• * Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH:
• * 23 kg/m2 in Asians\]), or increased waist circumference ≥ 102 cm (40 in) in men and ≥ 88 cm (35 in) in women (men ≥ 90 cm \[35.4 in\]; women ≥ 80 cm \[31.5 in\] in Asians).
• * 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.
• * Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening.
• * Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.
• * Known or suspected cirrhosis or signs of hepatic decompensation.
• * Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.
• * History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.
• * Uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 100 mm Hg).
• * Current use of medications prohibited due to potential drug-drug interactions with study treatment.
• * Contraindications to magnetic resonance imaging (MRI).