Evaluating the Pharmacokinetics and Safety of Miricorilant

Phase 1RecruitingNCT07553663

Corcept Therapeutics15 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

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)

Interventions

MiricorilantDRUG

Single dose of 60 mg miricorilant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Site# 433

San Antonio, Texas, United States

RECRUITING