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NCT06947304 | NOT YET RECRUITING | Nonalcoholic Steatohepatitis (NASH)

Evaluation of Miricorilant on Liver Fat in Patients With MASLD
Sponsor:

Corcept Therapeutics

Brief Summary:

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

Condition or disease

Nonalcoholic Steatohepatitis (NASH)

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Non-alcoholic Fatty Liver Disease (NAFLD)

Intervention/treatment

Miricorilant

Phase

PHASE1

Detailed Description:

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 14 weeks, comprising a 6-week screening period, a 4-week treatment phase, and a 4-week follow-up period.

Study Type : INTERVENTIONAL
Estimated Enrollment : 8 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Actual Study Start Date : 2025-06-16
Estimated Primary Completion Date : 2025-09-30
Estimated Study Completion Date : 2025-09-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Evaluation of Miricorilant on Liver Fat in Patients With MASLD

Location Details

NCT06947304

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How to Participate

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Locations

Not yet recruiting

United States, Missouri

University of Missouri

Columbia, Missouri, United States, 65211