RECRUITING

Evaluation of Miricorilant on Liver Fat in Patients With MASLD

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Conditions

Nonalcoholic Steatohepatitis (NASH)Metabolic Dysfunction-Associated Steatohepatitis (MASH)Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)Non-alcoholic Fatty Liver Disease (NAFLD)Nonalcoholic Fatty Liver Disease (NAFLD)Metabolic dysfunction-Associated Steatosis Liver Disease (MASLD)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Official Title

A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Quick Facts

Study Start:2025-08-01
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06947304

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Evidence of liver fibrosis with either FibroScan liver stiffness measurement ≥ 8 kPa and CAP ≥ 280 dB/m OR historical biopsy within 12 months of screening that meets the following criteria:
  2. 1. NAFLD Activity Score (NAS) ≥ 3 with ≥ 1 point in each subcomponent of steatosis, inflammation, and ballooning, and a NASH CRN fibrosis score of F1 OR
  3. 2. NAS ≥ 2 with ≥ 1 point in subcomponent of steatosis and ≥ 1 point in subcomponent of ballooning or inflammation, and a NASH CRN fibrosis score of F2 or 3
  4. * 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.
  5. * FIB-4 score of ≥ 1.3. The FIB-4 inclusion criterion does not apply to participants with an eligible historical liver biopsy performed within 12 months of screening.
  6. * MRI-PDFF with ≥ 8% steatosis; this assessment must be performed within 4 weeks of the Baseline Visit.
  7. * Have a stable weight within the last 6 months, defined by no more than a 5% loss of initial body weight.
  8. * Presence of at least 1 of the following metabolic syndrome characteristics that increase the risk of MASH:
  9. * 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).
  1. * Participation in another clinical trial for MASH or weight loss (e.g., GLP-1 receptor agonists) within the last 3 months.
  2. * Participation in any other clinical trial within the last 3 months or 5 half-lives of the treatment, whichever is longer.
  3. * Women who are pregnant, planning to become pregnant, or lactating.
  4. * BMI \< 18 kg/m² or \> 45 kg/m².
  5. * Significant alcohol consumption exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening.
  6. * Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids.
  7. * Known or suspected cirrhosis or signs of hepatic decompensation.
  8. * Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease.
  9. * History of myocardial infarction, unstable angina, or stroke within 3 months prior to screening.
  10. * Uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 100 mm Hg).
  11. * Current use of medications prohibited due to potential drug-drug interactions with study treatment.
  12. * Contraindications to magnetic resonance imaging (MRI).

Contacts and Locations

Study Contact

Elizabeth Parks, PhD
CONTACT
(573) 882-5864
parksej@missouri.edu

Principal Investigator

Kavita Juneja, MD
STUDY_DIRECTOR
Corcept Therapeutics

Study Locations (Sites)

University of Missouri
Columbia, Missouri, 65211
United States

Collaborators and Investigators

Sponsor: Corcept Therapeutics

  • Kavita Juneja, MD, STUDY_DIRECTOR, Corcept Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-01
Study Completion Date2026-03

Study Record Updates

Study Start Date2025-08-01
Study Completion Date2026-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Nonalcoholic Steatohepatitis (NASH)
  • Metabolic Dysfunction-Associated Steatohepatitis (MASH)
  • Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
  • Non-alcoholic Fatty Liver Disease (NAFLD)