Metabolic Dysfunction-Associated Steatohepatitis (MASH), 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 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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 16 weeks, comprising a 6-week screening period, a 6-week treatment phase, and a 4-week follow-up period.
Interventions
DRUGMiricorilant
100 mg administered orally, once daily
Sponsors
Corcept Therapeutics
University of Missouri-Columbia
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in fasting hepatic lipogenesis after 6 weeks of treatment | Baseline to Week 6 |
| Change in peak lipogenesis after 6 weeks of treatment. | Baseline to Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in liver fat content by MRI-PDFF after 6 weeks of treatment | Baseline to week 6 |
Countries
United States
Contacts
STUDY_DIRECTORKavita Juneja, MD
Corcept Therapeutics
Outcome results
None listed