Evaluating the Pharmacokinetics and Safety of Miricorilant
Purpose
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
- Non-alcoholic Fatty Liver Disease (NAFLD)
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Miricorilant 60mg |
Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant. |
|
Recruiting Locations
Site# 433
San Antonio, Texas 78215
San Antonio, Texas 78215
More Details
- Status
- Recruiting
- Sponsor
- Corcept Therapeutics
Detailed Description
Approximately 15 patients who are eligible for participation in the study will be administered a single dose of 60 mg of miricorilant. The maximum expected duration of a patient's participation is 56 days (up to 28 days of screening, followed by single-dose administration and 4 days of observation, and then 24 days of follow-up).