Actively Recruiting

Phase 1
Age: 18Years - 75Years
All Genders
NCT06947304

Evaluation of Miricorilant on Liver Fat in Patients With MASLD

Led by Corcept Therapeutics · Updated on 2026-02-11

8

Participants Needed

1

Research Sites

36 weeks

Total Duration

On this page

Sponsors

C

Corcept Therapeutics

Lead Sponsor

U

University of Missouri-Columbia

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Evaluation of Miricorilant on Liver Fat in Patients With MASLD

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • AST > 17 U/L for women and AST > 20 U/L for men, unless a qualifying liver biopsy within 12 months shows specific NAFLD Activity Scores and fibrosis levels
  • MRI-PDFF showing at least 8% liver fat, performed within 4 weeks before baseline
  • Presence of at least one metabolic syndrome characteristic increasing MASH risk, such as type 2 diabetes managed with diet or stable metformin, or three or more metabolic syndrome components including elevated blood glucose, blood pressure, triglycerides, low HDL cholesterol, or overweight/obesity
Not Eligible

You will not qualify if you...

  • Participation in another clinical trial for MASH or weight loss within the last 3 months
  • Participation in any clinical trial within the last 3 months or 5 half-lives of treatment, whichever is longer
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • BMI less than 18 kg/m2 or greater than 45 kg/m2
  • Significant alcohol use exceeding 20 g/day for women or 30 g/day for men within 1 year prior to screening
  • Positive urine drug screen for amphetamines, cocaine, opiates, or cannabinoids
  • Known or suspected liver cirrhosis or signs of liver failure
  • Other chronic liver diseases such as hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, or Wilson's disease
  • History of recent heart attack, unstable angina, or stroke within 3 months
  • Uncontrolled high blood pressure (systolic > 160 mm Hg or diastolic > 100 mm Hg)
  • Current use of medications that may interact with the study drug
  • Contraindications to MRI scanning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Missouri

Columbia, Missouri, United States, 65211

Actively Recruiting

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Research Team

E

Elizabeth Parks, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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