Evaluating the Pharmacokinetics and Safety of Miricorilant

Recruiting now · Phase 1

Conditions studied: 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)

In brief

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

Key facts

Study ID

NCT07553663

Run by

Corcept Therapeutics

People needed

15

Starts

2026-04-30

Expected to finish

2026-10-30

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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
• 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:
• Diagnosis of type 2 diabetes OR
• 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).

You may not qualify if…

• 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

Where it is running

• Site# 433 — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.