Evaluation of Miricorilant on Liver Fat in Patients With MASLD

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Approximately 8 patients who are eligible for participation in the study will be assigned to a single dose cohort receiving 100 mg of miricorilant daily. The total duration of participation for each patient is expected to be up to 16 weeks, comprising a 6-week screening period, a 6-week treatment phase, and a 4-week follow-up period.

Inclusion Criteria:

• 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 showing one of the following:

  1. NAFLD Activity Score (NAS) ≥ 4 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH Clinical Research Network (CRN) fibrosis score of F0 OR
  2. NAS ≥ 3 (with at least 1 point in each subcomponent of steatosis, inflammation, and ballooning) and NASH CRN fibrosis score of F1 OR
  3. NAS ≥ 2 (with at least 1 point in subcomponent of ballooning or inflammation) and a NASH CRN fibrosis score of F2-3

• MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.

• 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