Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Conditions
Keywords
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Metabolic dysfunction-Associated Steatohepatitis (MASH), Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)
Brief summary
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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).
Interventions
DRUGMiricorilant
Single dose of 60 mg miricorilant
Sponsors
Corcept Therapeutics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of miricorilant PK parameters | Day 1- Day 4 | Time to maximum concentration (Tmax) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (AEs), serious adverse events (SAEs), clinical laboratory evaluations, (hematology, clinical chemistry, urinalysis), 12-lead electrocardiograms (ECGs), vital sign measurements and physical examinations. | Day 1- Day 28 |
Countries
United States
Contacts
CONTACTEric Lawitz, MD
CONTACTToluwalase Okubote, MBBS, MPH, PMP
STUDY_DIRECTORAprille Espinueva, PharmD
Corcept Therapeutics
Outcome results
None listed