Evaluating the Pharmacokinetics and Safety of Miricorilant

Summary

A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Eligibility

Inclusion Criteria:

* 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
     * Systolic blood pressure ≥ 130 mm Hg, diastolic blood pressure ≥ 85 mm Hg, or treatment for hypertension
     * Serum triglycerides ≥ 150 mg/dL (1.7 mmol/L) or drug treatment for elevated triglycerides
     * Serum high-density lipoprotein (HDL) cholesterol \< 40 mg/dL (1 mmol/L) in men and \< 50 mg/dL (1.3 mmol/L) in women or drug treatment for low HDL
     * Overweight or obese (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).

Exclusion Criteria:

* 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
* History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
* Have hepatic decompensation

Other exclusion criteria may apply

Conditions5

Interventions1

Locations1 site

Find trials near these locations

Related trials

• Evaluation of Miricorilant on Liver Fat in Patients With MASLD — Corcept Therapeutics

Browse More Trials