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Recruiting NCT07553663

Evaluating the Pharmacokinetics and Safety of Miricorilant

Phase I Interventional 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)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Miricorilant.
Who it may be relevant to
Registry 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). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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).

Interventions

  • Drug Miricorilant
    Single dose of 60 mg miricorilant

Primary outcome measures

  • 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]
Secondary outcome measures (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. [Time frame: Day 1- Day 28]

Eligibility criteria

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:
  • 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).

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Site# 433 — San Antonio

Identifiers

NCT: NCT07553663 · CORT118335-863

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗