Recruiting
Phase 1

Miricorilant

Sponsor:

Corcept Therapeutics

Code:

NCT07553663

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 Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Miricorilant

Study Details

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)

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)

Study ID

NCT07553663

Start date

Apr 30, 2026

Status verified date

May, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Miricorilant 60mg

Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant.

Interventions

Miricorilant

Single dose of 60 mg miricorilant

Primary outcome measure

  • Assessment of miricorilant PK parameters [ Time Frame: Day 1- Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]
  • Assessment of miricorilant PK parameters [ Time Frame: Day 1 - Day 4 ]

Central Contacts and Locations

Central contacts

Eric Lawitz, MD

210-253-3426lawitz@txliver.com

Toluwalase Okubote, MBBS, MPH, PMP

210-253-3426tokubote@txliver.com

Locations

Site# 433

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

Corcept Therapeutics

Last update posted

May 26, 2026

Last verified

May, 2026

Keywords

  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis (NASH)
  • Metabolic dysfunction-Associated Steatohepatitis (MASH)
  • Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Corcept Therapeutics on 2026-05-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.