Evaluation of Miricorilant on Liver Fat in Patients With MASLD

Launched by CORCEPT THERAPEUTICS · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Miricorilant to see how it affects liver fat in patients with a condition known as Metabolic Dysfunction-Associated Steatohepatitis (MASH), which is a type of fatty liver disease. The trial aims to understand if this medication can help reduce fat in the liver, which is important for improving overall liver health. The study is currently not recruiting participants, but it will include adults aged between 18 and 75 who have specific signs of liver damage and certain metabolic health issues, such as type 2 diabetes or obesity.

To participate, individuals must have evidence of liver fibrosis, which means there is some scarring in the liver. They should also have a stable weight and meet other health criteria related to their liver and metabolic health. Participants will receive the treatment and will be monitored closely throughout the trial to track its effects and any side effects. It's essential for potential participants to be aware that they cannot be involved in other clinical trials or have certain health conditions, such as significant alcohol use or serious heart problems. This study is a step towards finding better treatments for fatty liver disease and its related health issues.

Gender

ALL

Eligibility criteria

• Inclusion 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:
• • a. Diagnosis of type 2 diabetes managed with diet alone or diet and metformin (metformin dose must be stable for at least 1 month prior to screening) OR b. Presence of 3 or more components of metabolic syndrome: i. Fasting blood glucose ≥ 100 mg/dL (5.6 mmol/L) or treatment for elevated blood glucose with metformin ii. Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension iii. Serum TG ≥ 150 mg/dL (1.7 mmol/L) iv. Serum high-density lipoprotein cholesterol (HDL) \< 40 mg/dL (1 mmol/L) in men and \< 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL v. Having overweight or obesity (body mass index \[BMI\] ≥ 25 kg/m2 \[BMI
• • 23 kg/m2 in Asians\]), 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).
• • Other inclusion criteria may apply
• Exclusion Criteria:
• • 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).
• • Other exclusion criteria may apply