Evaluating the Pharmacokinetics and Safety of Miricorilant

NCT07553663 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CORT118335-863
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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 Steatotic Liver Disease (MASLD); Non-alcoholic Fatty Liver Disease (NAFLD); Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• 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

Study Arms (1)

Miricorilant 60mg

EXPERIMENTAL

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

Drug: Miricorilant

Interventions

Miricorilant DRUG

Single dose of 60 mg miricorilant

Miricorilant 60mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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)
• Have any other chronic liver disease
• History of cirrhosis or evidence of cirrhosis by clinical, imaging, or liver biopsy evaluation
• Have hepatic decompensation

Sponsors & Collaborators

• Corcept Therapeutics: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Aprille Espinueva, PharmD

  Corcept Therapeutics

  STUDY DIRECTOR

Central Study Contacts

Eric Lawitz, MD

CONTACT

210-253-3426; lawitz@txliver.com

Toluwalase Okubote, MBBS, MPH, PMP

CONTACT

210-253-3426; tokubote@txliver.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 28, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share