Evaluating the Pharmacokinetics and Safety of Miricorilant

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

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

Study Overview

• Status: Recruiting
• Conditions: Nonalcoholic Steatohepatitis (NASH); Non-alcoholic Fatty Liver Disease (NAFLD); Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
• Intervention / Treatment: Drug: Miricorilant

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).

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Eric Lawitz, MD; Phone Number: 210-253-3426; Email: lawitz@txliver.com
• Study Contact Backup: Name: Toluwalase Okubote, MBBS, MPH, PMP; Phone Number: 7003 210-253-3426; Email: tokubote@txliver.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • Site# 433

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Miricorilant 60mg; Patients who meet the entry criteria for study CORT118335-863 will be administered a single dose of 60 mg miricorilant.	Drug: Miricorilant; Single dose of 60 mg miricorilant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of miricorilant PK parameters	Time to maximum concentration (Tmax)	Day 1- Day 4
Assessment of miricorilant PK parameters	Maximum concentration over the dosing interval (Cmax)	Day 1 - Day 4
Assessment of miricorilant PK parameters	Concentration at 24 hours post-dose (C24)	Day 1 - Day 4
Assessment of miricorilant PK parameters	Area under the concentration-time curve from time 0 to time of last measurable concentration (AUC(0-last))	Day 1 - Day 4
Assessment of miricorilant PK parameters	Area under the concentration-time curve from time 0 to time 24 hours post-dose (AUC(0-24))	Day 1 - Day 4
Assessment of miricorilant PK parameters	Area under the concentration-time curve from time zero extrapolated to infinity (AUC(0-inf)),	Day 1 - Day 4
Assessment of miricorilant PK parameters	Partial areas under the concentration-time curve from time 0 to time 6 hours and/or 8 hours post-dose (AUC(0-6), AUC(0-8))	Day 1 - Day 4
Assessment of miricorilant PK parameters	Apparent terminal elimination half-life (T1/2)	Day 1 - Day 4

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Corcept Therapeutics
• Investigators: Study Director: Aprille Espinueva, PharmD, Corcept Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: April 14, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nonalcoholic Steatohepatitis (NASH); Nonalcoholic Fatty Liver Disease (NAFLD); Metabolic dysfunction-Associated Steatohepatitis (MASH); Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: CORT118335-863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No